S. 409Senate112th Congress (2011-2013)In Committee

Combating Dangerous Synthetic Stimulants Act of 2011

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Placed on Senate Legislative Calendar under General Orders. Calendar No. 120.

July 28, 2011

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SenateIntro Referral

Introduced in Senate

February 17, 2011

SenateIntro Referral

Read twice and referred to the Committee on the Judiciary.

Judiciary Committee

February 17, 2011

SenateCommittee

Committee on United States Senate Caucus on International Narcotics Control. Hearings held.

United States Senate Caucus on International Narcotics Control

April 6, 2011

SenateCommittee

Committee on the Judiciary. Ordered to be reported without amendment favorably.

Judiciary Committee

July 28, 2011

SenateCommittee

Committee on the Judiciary. Reported by Senator Leahy without amendment. Without written report.

Judiciary Committee

July 28, 2011

SenateCalendars

Placed on Senate Legislative Calendar under General Orders. Calendar No. 120.

July 28, 2011

Floor Debate

24 members

What members said about S. 409 on the floor

+19

9 Republicans15 Democrats

Sen. Richard J. DurbinD-IL · May 24, 2012

Mr. President, I think that accommodation was to allow the Senator from Louisiana for 7 minutes, and I would ask for 5 minutes before the votes begin. Mr. President, today we are considering a bill…

Mr. President, I think that accommodation was to allow the Senator from Louisiana for 7 minutes, and I would ask for 5 minutes before the votes begin.

Mr. President, today we are considering a bill that will improve the FDA's ability to assure the

safety of drugs in our medicine cabinets and medical devices in our hospitals. The FDA is an essential guardian of the public's health and safety. In the past few years, FDA has faced obstacles that call on the agency to adapt and respond to the evolving nature of reviewing, manufacturing, and distributing drugs and devices.

Some of those obstacles and challenges are addressed in the reauthorizations of the Prescription Drug User Fee Act and the Medical Device User Fee Act, which are set to expire at the end of September 2012.

Last fall, I visited Cook Medical's medical device plant in Canton, Illinois, and representatives expressed concern about the amount of time it takes medical devices to be reviewed. The FDA needs sufficient time to review medical devices, in order to ensure their safety and effectiveness. However, inefficiencies and insufficient resources can result in longer review times, which mean patients have to wait longer to benefit from new medical devices.

This bill makes key changes to maintain the safety of devices and preserve our country's leadership in biomedical innovation. The bill will authorize the FDA to collect almost $600 million in user fees over 5 years. The FDA can use these additional resources to help hire and train staff.

Furthermore, the bill makes important improvements by streamlining the review process for devices and increasing communication between the FDA and device manufacturers throughout the review process. These changes to the review of medical devices will not only help innovative device companies get their product to market faster, but will prevent patients from having to wait extra weeks and months to benefit from a new device.

In addition to reauthorizing the Prescription Drug and Medical Device User Fee Acts, this bill also establishes the Drug User Fee Act and Biosimilar User Fee Act, which gives the FAA new authority to collect user fees for generic and biosimilar drugs. Currently the FDA does not collect user fees to support the review of generic drugs, and it takes about 30 months for the agency to review generic drug applications. This extra time reduces access to safe, affordable generic drugs and leaves patients and taxpayers paying the tab for brand-name drugs that lack competition from generics.

Since the first Prescription Drug User Fee Act was enacted in 1992, the FDA began collecting user fees to support the review of applications. The FDA has cut the review time for new drugs by 60%, from 2 years to a little over 1 year. Similarly, the Generic Drug User Fee Act will give the FDA the support it needs to cut the current 30- month review time for generic drugs down to 10 months. This improvement will promote competition in the marketplace and save money by reducing the amount of time patients have to wait for less expensive generic alternatives to brand name drugs. The process of negotiating and drafting this legislation started 18 months ago and the result is a comprehensive bill that improves the safety and quality of drugs and medical devices.

Chairman Harkin and Senator Enzi have put together a bill that responds to many of these challenges, including one that is of particular interest to me----the national shortage of critical drugs. Between 2006 and 2010 the drug shortage increased 200 percent from 56 to 178 drugs. Currently the drug shortage includes over 200 drugs, like intravenous nutrition supplements, cancer treating drugs, and anesthesia.

Over the past few months, I have held three roundtable discussions at hospitals across Illinois to learn about the drug shortage and how it is affecting providers and patients. From these discussions it is clear that the drug shortage is being felt at most hospitals and those Illinois hospitals, providers, and pharmacists are working around the clock to ensure patients maintain access to drugs and safe treatments.

At Advocate Hospital in Libertyville, a doctor shared that he learned just days before starting a patient on chemotherapy that the drug was not available. Unfortunately, this is a common scenario across the country as doctors learn days before starting a treatment or even once the patient is on the hospital bed that a drug is not available. Pharmacists now spend part of each day scrambling to find drugs or an alternative treatment.

Recently I learned that a young woman on my staff here in D.C. is all too familiar with the drug shortage. She is a smart and hard-working woman who has been taking Concerta to treat her ADD since she was 14. Like most people with severe ADD, she must take her medicine at a certain time every day in order to keep her ADD symptoms from impeding basic life and work responsibilities. And while there are several ADD drugs on the market, each drug works differently and can have different side effects, so switching to a new prescription is not without risk.

Last year, the local CVS where she usually had her prescription filled started telling her they didn't have her drug in stock. She didn't think much of it as she would wake up early and walk to another CVS in the morning where she was usually able to get the prescription. Over time, she grew accustomed to going between these two CVS pharmacies to fill her prescription.

Until one month, when she carried her prescription with her for 3 days and was unable to find a pharmacy with enough Concerta to fill her 30-day prescription.

By the end of day 3, she was out of her supply. She woke up early and rode her bike to four or five CVS pharmacies until she was able to find a pharmacy that could fill her prescription. But by then it was 12 o'clock and past the prescribed time to take the drug.

The shortage of ADD drugs impacts children, adults, parents, and employees across the country. Congress needs to take action to address the drug shortage.

The FDA Safety and Innovation Act builds on Senator Klobuchar's bill with key provisions to curb the national drug shortage. First, the bill requires drug manufacturers to notify the FDA 6 months in advance for certain drug shortages. With this much notice, the FDA can work with manufacturers to try to avoid a shortage and, when necessary, identify alternative sources of the drug to ensure we maintain a supply for patients.

This winter, thanks to open communication between the FDA and drug companies, the FDA successfully avoided a shortage of methotrexate, a vital drug to treat leukemia in children. The FDA collaborated with Illinois-based generic drug manufacturer, Hospira, to increase production of this live-saving drug when another company halted production. Requiring 6 months advance notice of a drug shortage will help the FDA to work with companies to avoid shortages of critical drugs.

Furthermore, the bill requires FDA to enhance the agency's response to shortages and will improve reporting of shortages by allowing third- parties to report drug shortages to the FDA.

This bill also takes steps to improve the safety of drugs and the drug supply chain.

In 2008, serious injuries and 81 deaths were linked to contamination of the crucial blood thinning drug heparin. The source of the contamination was a facility in China that intentionally adulterated the drug. This was a horrible illustration of what happens when adulterated and counterfeit drugs make their way into the drug supply chain and ultimately to patients. This case has also raised serious questions about the global manufacturing practices of drugs and drug ingredients and the FDA's responsibility to protect the drug supply chain.

Since the heparin incident, the global nature of the drug supply chain has only grown. Today 80 percent of active pharmaceutical ingredients are manufactured outside of the United States. This bill improves the safety of our supply chain, both domestically and internationally by requiring foreign manufacturers to register their facilities with the FDA. The bill also places greater responsibility on U.S. drug manufacturers to know their international suppliers and increases penalties for intentionally contaminating or counterfeiting drug. Counterfeit and adulterated drugs can have deadly consequences, yet the penalty for committing these crimes is less than the penalty for selling a counterfeit designer purse.

Currently, the penalty for intentionally counterfeiting or adulterating a drug is no more than 3 years in prison or a $10,000 fine or both.

This bill raises the penalty for intentionally adulterating a drug to no more than 20 years in prison or a $1 million fine or both.

And the penalty for intentionally counterfeiting drugs is raised to no more than 20 years in prison or a $4 million fine or both.

This bill addresses the drug shortage, reduces the review time for medical devices and drugs, improves the pipeline for antibiotics and pediatric drugs, and helps secure the supply chain for prescription drugs.

I would like to thank Chairman Harkin and Senator Enzi for their extraordinary leadership and hard work on this bill.

The amendment we will face this afternoon is one I am offering relative to dietary supplements. I want to make it clear what this is about.

If someone walked into their neighborhood drugstore and looked at everything on the shelf, here is what they can say: All the prescription drugs the pharmacy has access to have been reviewed by the Food and Drug Administration that they are safe and effective. All of the over-the-counter drugs have been reviewed and registered with the Food and Drug Administration to make certain they are safe and have been precleared before they can be sold. Now when they move back to the vitamin counter, all bets are off. Those are called dietary supplements. They are not subject to the same level of scrutiny, inspection, testing or regulation. It is an entirely different world.

It is understandable that there are those of us who want to be able to walk in and buy vitamins, for example, without a prescription. That is our right as Americans. But we also want to make sure that whatever is on the shelf at the pharmacy is not dangerous or at least we know it is there.

There are between 55,000 and 75,000 dietary supplements in America. We don't know the exact number. They include the obvious, vitamins and minerals, but they also go further. They include energy drinks. Ever heard of the 5-Hour Energy Drink, Monster Energy Drink? Those are not sold as colas, sodas, or beverages. They are sold as dietary supplements. Why? Because there is no regulation in terms of their contents.

We had a sad story I told on the Senate floor 2 days ago, with the family in the gallery, about a 16-year-old girl from Hagerstown, MD, who drank two Monster Energy Drinks within a 24-hour period and went into cardiac arrest. It was too much for her heart. She died. That was a dietary supplement.

My amendment says if they want to sell a dietary supplement in the United States, they have to do one basic thing: They have to go to the Food and Drug Administration and say: This is the name of my company. This is the name of my product and the ingredients in it. And here is a copy of the label. That is it.

So is it important that we know this? There will be 1,000 new products bought and sold in the United States as dietary supplements every year. Just in case we think knowing the dietary supplement facility company has been registered is enough, hang on tight. These dietary supplements are coming from all over the world. Sadly, a lot of them turn out to be dangerous.

In 2009 the FDA announced that Super Slim, a dietary supplement manufactured in China, contained the pharmaceutical ingredient sibutramine, which is no longer available in the United States and found to increase the risk of heart attack or stroke. If the manufacturers had registered this dietary supplement so we knew the ingredient, we could protect American consumers.

The same thing was true in 2001. Another Chinese-based weight-loss ingredient, aristolochic acid, was found to cause kidney damage and to be a potent carcinogen. Isn't it important for us to know this? Is it too much to ask the dietary supplement companies to go to the FDA and at least register their products before they put them on the shelves across America? Don't American families have the right to scrutiny and at least some basic knowledge of the sale of these products?

The industry is against this. They don't want to report it. They basically say: It is none of your business. We will sell what we want to sell, and that is the way it will be. If we want to volunteer the information, so be it. But we don't want to be required to disclose the information.

There are groups that see it differently. I ask unanimous consent to have printed in the Record letters that support my amendment. The Center for Science and Public Interest and the Consumers Union are in support of this amendment.

I ask my colleagues when this vote comes before us, before we have another death in America from a dietary supplement from China, India, Mexico, or even in the United States, shouldn't we require the most basic information so we know the name of the company, the ingredients in the product, and what the label looks like?

The FDA has asked for this information. They asked expressly for this information. To say it is a burden on them, they already asked for it.

I ask my colleagues when this amendment comes up later this afternoon that they support this in the best interest of protecting American families and consumers.

I yield the floor.

I announce that the Senator from Connecticut (Mr. Blumenthal) and the Senator from Maryland (Ms. Mikulski) are necessarily absent.

I announce the Senator from Connecticut (Mr. Blumenthal) is necessarily absent.

I announce that the Senator from Hawaii (Mr. Akaka), the Senator from Connecticut (Mr. Blumenthal), the Senator from California (Mrs. Boxer), and the Senator from Michigan (Ms. Stabenow) are necessarily absent.

I announce that the Senator from Connecticut (Mr. Blumenthal) is necessarily absent.

Mr. President, this is a very simple amendment. If you go into the drugstore and look at the prescription drugs, every one of them has been registered with the FDA. The over-the-counter drugs have all been registered. When you go to the dietary supplement section, there is no requirement under the law for the company selling those products to register the name of the product, the ingredients of it, or a copy of the label.

The GAO did a study in 2009, and the FDA said we need this information to protect American consumers. From what? One of them is an example on this chart. This is a Chinese product that was imported into the United States, put up for sale, and then we discovered that one of the ingredients was life-threatening. It was never registered with the FDA, and there was no disclosure of its ingredients.

If you want to sell from the counters in America, shouldn't you be required, whether you are from China, India, Mexico, or anywhere in the United States, to register your product, the ingredients in it, and a copy of the label? The FDA says they need this information to keep America safe.

Mr. President, I ask unanimous consent to have the same amount of time given on the other side.

Mr. President, the FDA asked for this knowledge and information. What am I asking them to disclose? The name of the product, the ingredients of it, and a copy of the label. If a Chinese manufacturer wants to sell a dietary supplement in Des Moines, IA, shouldn't they have to report to the FDA the name of the product and its ingredients? It is not required by law now. Let's give the FDA this extra information to keep Americans safe.

Madam President, today, we are considering a bill that will improve the FDA's ability to assure the safety of drugs in our medicine cabinets and medical devices in our hospitals.

The FDA is an essential guardian of the public's health and safety.

In the past few years, FDA has faced obstacles that call on the agency to adapt and respond to the evolving nature of reviewing, manufacturing, and distributing drugs and devices.

Last fall, I visited Cook Medical's medical device plant in Canton, IL, and representatives expressed concern about the amount of time it takes medical devices to be reviewed.

FDA needs sufficient time to review medical devices in order to ensure their safety and effectiveness. However, inefficiencies and insufficient resources can result in longer review times, which means patients have to wait longer to benefit from new medical devices.

This bill makes key changes to maintain the safety of devices and preserve our country's leadership in biomedical innovation.

The bill will authorize the FDA to collect almost $600 million in user fees over 5 years. FDA can use these additional resources to help hire and train staff.

Furthermore, the bill makes important improvements by streamlining the review process for devices and increasing communication between the FDA and device manufacturers throughout the review process.

These changes to the review of medical devices will not only help innovative device companies get their product to market faster but will prevent patients from having to wait extra weeks and months to benefit from a new device.

In addition to reauthorizing the Prescription Drug and Medical Device User Fee Acts, this bill also establishes the Generic Drug User Fee Act and Biosimilar User Fee Act, which give FDA new authority to collect user fees for generic and biosimilar drugs.

Currently the FDA does not collect user fees to support the review of generic drugs, and it takes about 30 months for the agency to review generic drug applications. This extra time reduces access to safe, affordable generic drugs and leaves patients and taxpayers paying the tab for brand-name drugs that lack competition from generics.

Since the first Prescription Drug User Fee Act was enacted in 1992, the FDA began collecting user fees to support the review of applications.

FDA has cut the review time for new drugs by 60 percent, from 2 years to a little over 1 year.

Similarly, the Generic Drug User Fee Act will give FDA the support it needs to cut the current 30-month review time for generic drugs down to 10 months.

This improvement will promote competition in the marketplace and save money by reducing the amount of time patients have to wait for less expensive generic alternatives to brand-name drugs.

The process of negotiating and drafting this legislation started 18 months ago, and the result is a comprehensive bill that improves the safety and quality of drugs and medical devices.

Chairman Harkin and Senator Enzi have put together a bill that responds to many of these challenges, including one that is of particular interest to me--the national shortage of critical drugs.

Between 2006 and 2010 the drug shortage increased 200 percent--from 56 to

178 drugs. Currently the drug shortage includes over 200 drugs, such as intravenous nutrition supplements, cancer treating drugs, and anesthesia.

Over the past few months, I have held three roundtable discussions at hospitals across Illinois to learn about the drug shortage and how it is affecting providers and patients. From these discussions it is clear that the drug shortage is being felt at most hospitals, and those Illinois hospitals, providers, and pharmacists are working around the clock to ensure patients maintain access to drugs and safe treatments.

Pharmacists now spend part of each day scrambling to find drugs or an alternative treatment.

I recently learned that a young woman on my staff here in DC is all too familiar with the drug shortage. She is a smart and hardworking woman who has been taking Concerta to treat her ADD since she was 14. Like most people with severe ADD, she must take her medicine at a certain time every day in order to keep their ADD symptoms from impeding basic life and work responsibilities. And while there are several ADD drugs on the market, each drug works differently and can have different side effects, so switching to a new prescription is not without risk.

Last year, the local CVS where she usually had her prescription filled started telling her they didn't have her drug in stock. She didn't think much of it, as she would wake up early and walk to another CVS in the morning where she was usually able to get the prescription.

Over time, she grew accustomed to going between these two CVS pharmacies to fill her prescription until one month when she carried her prescription with her for 3 days and was unable to find a pharmacy with enough Concerta to fill her 30-day prescription. By the end of day 3, she was out of her supply. She woke up early and rode her bike to four or five CVS pharmacies until she was able to find a pharmacy that could fill her prescription. But by then it was 12 o'clock and past the prescribed time to take the drug.

The shortage of ADD drugs impacts children, adults, parents, and employees across the country.

Congress must take action to address the drug shortage.

The FDA Safety and Innovation Act builds on Senator Klobuchar's bill, with key provisions to curb the national drug shortage.

First, the bill requires drug manufacturers to notify the FDA 6 months in advance for certain drug shortages.

With this much notice, the FDA can work with manufacturers to try to avoid a shortage and, when necessary, identify alternative sources of the drug to ensure we maintain a supply for patients.

This winter, thanks to open communication between the FDA and drug companies, the FDA successfully avoided a shortage of methotrexate, a vital drug to treat leukemia with children.

FDA collaborated with Illinois-based generic drug manufacturer Hospira to increase production of this lifesaving drug when another company halted production.

Requiring 6 months' advance notice of a drug shortage will help the FDA to work with companies to avoid shortages of critical drugs.

Furthermore, the bill requires FDA to enhance the agency's response to shortages and will improve reporting of shortages by allowing third parties to report drug shortages to the FDA.

This bill also takes steps to improve the safety of drugs and the drug supply chain.

This case has also raised serious questions about the global manufacturing practices of drugs and drug ingredients and the FDA's responsibility to protect the drug supply chain. Since the heparin incident, the global nature of the drug supply chain has only grown. Today, 80 percent of active pharmaceutical ingredients are manufactured outside of the United States.

This bill improves the safety of our supply chain both domestically and internationally by requiring foreign manufacturers to register their facilities with the FDA.

The bill also places greater responsibility on U.S. drug manufacturers to know their international suppliers and increases penalties for intentionally contaminating or counterfeiting drugs.

Counterfeit and adulterated drugs can have deadly consequences, yet the penalty for committing these crimes is less than the penalty for selling a counterfeit designer purse. Currently, the penalty for intentionally counterfeiting or adulterating a drug is no more than 3 ears in prison or a $10,000 fine or both. This bill raises the penalty for intentionally adulterating a drug to no more than 20 years in prison or a $1 million fine or both. And the penalty for intentionally counterfeiting drugs is raised to no more than 20 years in prison or a $4 million fine or both.

I thank Chairman Harkin and Senator Enzi for their extraordinary leadership and hard work on this bill.

Rep. Charles W. DentR-PA-15 · Dec 7, 2011

I certainly appreciate the support of Mr. Pitts and Mr. Pallone for their leadership on this issue. It's deeply appreciated. This issue of synthetic or designer drugs was first brought to my…

I certainly appreciate the support of Mr. Pitts and Mr. Pallone for their leadership on this issue. It's deeply appreciated.

This issue of synthetic or designer drugs was first brought to my attention by a woman, a mother in my district whose son had been abusing legal substitutes for marijuana. These synthetic cannabinoids, as they're referred to, or synthetic marijuana, affect the brain in a manner similar to marijuana, but can actually be even much more harmful.

Synthetic marijuana, or cannabinoids, are just one category of designer drugs. Even more potent substances have properties similar to cocaine, methamphetamine, LSD, and other hard street drugs. These substances are marketed as innocent products like bath salts, plant food, incense, and they're sold under brand names familiar to their users, such as K2 Spice, Vanilla Sky, or Ivory Wave. However, these are total misnomers designed to facilitate their legal sale. These drugs have no legitimate purpose, period.

H.R. 1254, the Synthetic Drug Control Act, drafted in consultation with Federal law enforcement, has three principal components:

First, a prohibition of broad structural classes of synthetic marijuana or the cannabinoids;

Two, a prohibition of synthetic stimulants and other designer drugs, such as bath salts, mephedrone, MDPV, C2E, et cetera, several of those;

Third, an expansion of the DEA's existing authority to temporarily ban a new substance from 1\1/2\ to 3 years. Under current law, if the DEA and Department of Health and Human Services can prove that a substance is, one, dangerous and, two, lacking legitimate value while it is temporarily banned, the prohibition will become permanent.

Over the past year there's been a sharp increase in the number of new reports detailing horrific stories of individuals high on synthetic drugs. A man in Scranton, Pennsylvania, stabbed a priest, and another jumped out a three-story window, both high on bath salts. Several deaths from West Virginia to Florida to Pennsylvania to Iowa have been attributed to abuse of synthetic drugs.

Senator Chuck Grassley of Iowa has introduced a companion bill with provisions very similar to H.R. 1254, named after one of his young constituents who tragically took his own life while high on synthetic marijuana.

A man in my district was arrested this past May for firing a gun out of his window in a university neighborhood. Police charges indicate that he injected himself with bath salts, and he later told police he thought there were people on the roof watching him.

Finally, I was approached by another distraught mother from my district whose son was hospitalized for over 2 weeks after suffering liver failure and other complications after injecting himself with bath salts. These substances pose a substantial risk, both to the physical health of the user as well as to the safety of those around them when these drugs contribute to dangerous, psychotic behavior, suicide, and public endangerment.

The fact that these drugs are legal in many States contributes to the misconception that they are safe. And the use of easily recognizable brand names and logos on the packaging promotes the concept of a consistent product.

Significant variations of potency from one unit to the next have led recurrent users to inadvertently overdose. One of the major difficulties in combating these designer drugs is the ability of the producers to skirt the law with different chemical variations. By modifying the formula in some minor way, producers can generate a new compound which circumvents legal prohibitions but has similar narcotic events. DEA needs enhanced authority to temporarily schedule new variations when they hit the market, and they usually hit Europe first, and then they enter the United States.

A growing number of States, including Pennsylvania, have enacted bans on many forms of synthetic drugs, but Federal action is necessary to prevent these drugs from being obtained by simply crossing State lines or, increasingly, ordering them over the Internet.

I believe over 30 States have passed bans, if my memory serves me correctly. State-by-State differences in which individual substances are controlled and how strongly makes for a confusing legal patchwork, and Federal legislation certainly will facilitate enforcement.

The U.S. Department of Justice announced its support of H.R. 1254 as amended by the House Judiciary Committee in a letter dated September 30, 2011, and I would submit that for the Record.

I also want to point out, too, that the American College of Emergency Physicians, which notes the devastating physical and psychotic effects of these drugs, has also endorsed this bill, and I think that's quite significant as well.

Finally, go to a hospital like Children's Hospital of Philadelphia-- they'll tell you they get a case every day with individuals who are suffering from these particular drugs. A year ago at this time, they probably got no calls. And now every day, and that's not just typical in Philadelphia but throughout the country. I urge my colleagues to support this legislation.

You will also hear some folks here today who might actually argue that medical research will somehow be impeded. Nothing could be further from the truth. This legislation does not in any way impede medical research. I would be happy to get into that at some point.

U.S. Department of Justice,

Office of Legislative Affairs,

Washington, DC, September 30, 2011.

Hon. F. James Sensenbrenner, Jr.,

Subcommittee on Crime, Terrorism, and Homeland Security,

Committee on the Judiciary, House of Representatives,

Washington, DC.

Dear Mr. Chairman. This letter provides the Department of

Justice's views on H.R.

1254, as amended by the Committee on Energy and Commerce,

titled the ``Synthetic Drug Control Act of 2011.'' The bill

would amend the Controlled Substances Act (CSA) to address

the growing use and misuse of synthetic drugs by placing a

number of substances in schedule I and by extending the

length of time that a drug may be temporarily placed in

schedule I.

We support the bill as drafted, but believe it can be

strengthened with the addition of the ``2C family'' of drugs

listed in an appendix to this letter and in S. 839. The

Department also supports the goals of S. 605, Dangerous

Synthetic Drug Control Act of 2011 or the ``David Mitchell

Rozga Act''; S. 839, Combating Designer Drugs Act of 2011;

and S. 409, Combating Dangerous Synthetic Stimulants Act of

2011. H.R. 1254 already contains many provisions included in

S. 605 and S. 409, and we urge that the bill be expanded to

include the provisions of S. 839.

The Threat of Synthetic Drugs

In recent years, a growing number of dangerous products

have been introduced into the U.S. marketplace. Products

labeled as ``herbal incense'' have become increasingly

popular, especially among teens and young adults. These

products consist of plant materials laced with synthetic

cannabinoids which, when smoked, mimic the deleterious

effects of delta-9- tetrahydrocannabinols (THC), the

principal psychoactive constituent in marijuana. To

underscore the scope and breadth of the synthetic cannabinoid

problem, a recent report prepared by the United Nations

Office on Drugs and Crime (UNODC) notes that more than 100

such substances have been synthesized and identified to

date.''

There is also growing evidence demonstrating the abuse of a

number of substances labeled as ``bath salts'' or ``plant

foods'' which, when ingested, snorted, smoked, inhaled, or

injected, produce stimulant and other psychoactive effects.

These synthetic stimulants are based on a variety of

compounds and are purported to be alternatives to the

controlled substances cocaine, amphetamine, and Ecstasy

(MDMA). These drugs have been distributed and abused in

Europe for several years and have since appeared here in the

United States. According to a recent National Drug

Intelligence Center report, poison control centers and

medical professionals around the country have reported an

increase in the number of individuals suffering adverse

physical effects associated with abuse of these drugs.

There are other newly developed drugs that also pose a

significant threat to the public. This includes the ``2C

family'' of drugs (dimethoxyphenethylamines), which are

generally referred to as synthetic psychedelic/hallucinogens.

Recently, a 19-year-old male in Minnesota died of cardiac

arrest after allegedly ingesting 2C-E, one of the substances

within this class of drugs. We note that the 2C substances

listed in the attached Appendix are included in the list of

substances covered by S. 839. The Department supports the

addition of the 2C family of substances listed in the

Appendix to H.R. 1254.

Products containing synthetic drugs are dangerous and

represent a growing challenge to law enforcement. Apart from

the wide array of harmful or even lethal side effects of many

of the listed substances, neither the products nor their

active ingredients have been approved by the Food and Drug

Administration for use in medical treatment, and

manufacturers and retailers of the products containing these

substances do not disclose that there are synthetic drugs in

their products. Synthetic drug abusers may endanger not only

themselves but others: some become violent when under the

influence of these substances, and abusers who operate motor

vehicles after using synthetic drugs likely present similar

dangers as those under the influence of controlled

substances.

With the exception of the five substances recently

controlled by the Drug Enforcement Administration (DEA)

pursuant to its temporary scheduling authority, the listed

synthetic cannabinoids and synthetic stimulants are not

currently in any schedule under the CSA.

Efforts to control Synthetic Drugs

Congress created an interagency process for placing new and

emerging drugs into one of five schedules of the CSA (21

U.S.C. 811 et seq.). One such mechanism, temporary scheduling

(21 U.S.C. 811(h)), was specifically designed to enable the

Department to act in an expeditious manner if such action is

necessary to avoid an imminent hazard to the public safety.

In response to the growing threat posed by known synthetic

cannabinoids, on March 1, 2011, the DEA temporarily placed

the following five synthetic cannabinoids in schedule I: JWH-

018, JWH-073, JWH-200, CP-47, 497, and CP-47, 497 C8

homologue.

The DEA is currently gathering scientific data and other

information about synthetic cathinones as well as evaluating

their psychoactive effects to support administrative action

to schedule these substances under the CSA. To temporarily

schedule these stimulants, the DEA must find that placement

in schedule I is necessary to avoid an imminent hazard to the

public safety, a finding that requires the DEA to consider

the following three factors: history and current pattern

of abuse; the scope, duration, and significance of abuse;

and what, if any, risk there is to the public health,

including actual abuse; diversion from legitimate

channels; and clandestine importation, manufacture, or

distribution. Once data have been gathered to meet the

statutory criteria to temporarily schedule these

cathinones, the Department will initiate an action to

temporarily place them into schedule 1. In fact, on

September 8, 2011, the DEA published a notice of intent in

the Federal Register (21 FR 55616) to temporarily place

mephedrone, methylone and MDPV in schedule I.

Unfortunately, however, the distribution and abuse of

synthetic drugs cannot be fully addressed by temporary

scheduling because as law enforcement investigates,

researches, and develops evidence to support such action,

illicit drug makers create new synthetic drugs for the

purpose of evading federal law. Scheduling via legislation is

an additional tool to promote public health and safety.

Purpose of Legislation

Placing synthetic carnnabinoid and synthetic stimulant

substances in schedule I would expose those who manufacture,

distribute, possess, import, and export synthetic drugs

without proper authority to the full spectrum of criminal,

civil, and administrative penalties, sanctions, and

regulatory controls. Unless authorized by the DEA, the

manufacture and distribution of these substances, and

possession with intent to manufacture or distribute them,

would be a violation of the CSA and/or the Controlled

Substances Import and Export Act.

H.R. 1254, as well as S. 409, would amend the CSA by

expanding the list of substances in schedule I of the CSA (21

U.S.C. 812(c)). To address synthetic cannabinoid abuse, the

bill names 15 unique substances that would be placed in

schedule I; this list includes those temporarily scheduled by

the DEA. Additionally, the bill creates five structural

classes of substances collectively referred to as

``cannabimimetic agents.'' In order for a substance to be a

cannabimimetic agent, the substance must: (1) bind to the CB1

receptor; and (2) meet any of the definitions for those

structural classes. If both criteria are met, that substance

will be a schedule I cannabimimetic agent controlled

substance.

To address emerging synthetic stimulant abuse, H.R. 1254

names 17 unique substances that would be placed in schedule

I. These substances have either been encountered by law

enforcement here in the United States or are most likely to

be encountered by law enforcement in the United States based

on their use and misuse in Europe, which is likely where the

use and misuse originated.

Finally, the bill seeks to double the amount of time

allowed for the Department to temporarily schedule new and

emerging drugs by amending 21 U.S.C. 811(h). In this regard,

the bill seeks to enhance the tools available to the

Department to combat the abuse of new drugs that will appear

in the future.

For these reasons, the Justice Department supports H.R.

1254 and recommends that the Committee consider strengthening

it in the ways we have proposed.

Thank you for the opportunity to present our views. The

Office of Management and Budget has advised us that from the

perspective of the Administration's program, there is no

objection to the submission of this letter.

Sincerely,

Ronald Weich,

Assistant Attorney General.

Appendix

Additional Synthetic Drugs for Inclusion in section 202(c)

of the Controlled Substances Act (21 U.S.C. 812(c)):

Redline of H.R. 1254, as amended by Energy and Commerce on

July 28, 2011--

``(35) 2-(2,5-Dimethoxy-4-ethylphenyl)

ethanamine (2C-E).

(36) 2-(2,5-Dimethoxy-4-methylphenyl)

ethanamine (2C-D).

(37) 2-(4-Chloro-2,5-dimethoxyphenyl)

ethanamine (2C-C).

(38) 2-(4-lodo-2,5-dimethoxyphenyl)

ethanamine (2C-I).

(39) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]

ethanamine (2C-T-2).

(40) 2-[4-(lsopropylthio)-2,5-dimethoxyphenyl

-[ethanamine (2C-T-4).

(41) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).

(42) 2-(2,5-Dimethoxy-4-nitro-phenyl)

ethanamine (2C-N).

(43) 2-(2.5-Dimethoxy-4-(n)-propylphenyl)

ethanamine (2C-P).''

I do want to address a few of the statements I heard on the floor from my friends from Tennessee and Virginia.

My friend from Tennessee made some comments, but I want to be very clear, these drugs are dangerous, have a high potential for abuse and no accepted medical use, which is why they belong on Schedule I. Schedules II and V are reserved for drugs used in legitimate medical procedures.

So we're talking about Schedule I here, not Schedules II through V. Let me be very clear on that point.

Second, the FDA has stated that the drugs listed in H.R. 1254 have no medical use, and there are no INDs--that is, investigational new drug applications--for these substances pending with the FDA. This is from the FDA. H.R. 1254 will not prevent further research into synthetic drugs. It's simply false to say that it will.

DEA has a routine, well-established procedure in place to facilitate scientific study of Schedule I drugs, including marijuana, cocaine, and heroin. Currently the DEA has licensed nearly 4,000 individuals and other entities, including universities, manufacturers, researchers, and labs to handle Schedule I drugs for scientific and investigational purposes. These are facts.

I also want to point out, my friend from Virginia made some comments about I guess eight compounds having been found in the United States. Actually, dozens of compounds have been found in the United States. Many bath salt chemicals currently are in the United States, but only three synthetic stimulants and five synthetic cannabinoids have been emergency

scheduled by the DEA because they have to go chemical by chemical in order to act on this matter. They have to deal with this on a chemical- by-chemical basis.

We need Congress to give the DEA authority to be more effective and get ahead of this problem. We know that these drugs are coming into this country from Europe. That's where they're coming from, these compounds. There are some in Europe right now. Our goal is to get out in front of this before they have a chance to be exported into the U.S.

Another comment I heard about 325 researchers, well, 325 researchers because that's all who have applied to do this type of research. DEA is not in the business of turning researchers away, so I want to be clear on these points.

There's so much more that can be said on this. But again, research will not be impeded in any way. There is a mechanism, there is a process in place to do research on these Schedule I drugs. It's well established. This has nothing to do with the medical marijuana debate. I heard that argued earlier, too. We're talking about synthetic marijuana and synthetic cocaine. This stuff is dangerous. And, in fact, some would argue worse than the real stuff, so let's get to it.

This is about public safety. This is about the health of our constituents. We know what's going on. In fact, somebody pointed out to me today that a store in Washington, D.C., a few blocks from the Capitol, somebody is selling this stuff. My State and over 30 other States have seen this problem. They know what's happening across this country. We need to do something about it. DEA is alarmed by this. Justice is on board. DEA is on board. Let's do something for the good of the American people. Please pass H.R. 1254, the Synthetic Drug Control Act of 2011. It's in the best interest of the American people, and the best interest of our children. We're doing the right thing.

Sen. Charles E. SchumerD-NY · May 24, 2012

I am speaking on the majority's time. No. I am speaking on the McCain amendment. Mr. President, I am going to speak for a brief moment on the amendment No. 2146 and then on a different issue, which…

I am speaking on the majority's time.

No. I am speaking on the McCain amendment.

Mr. President, I am going to speak for a brief moment on the amendment No. 2146 and then on a different issue, which is the reaction of some to the proposal Senator Casey and I made about Eduardo Saverin and others who renounced their citizenship for tax purposes.

First, on 2146. I am glad this amendment has now finally passed the Senate. It places synthetic drugs on schedule I of the Controlled Substances Act as totally banned substances, which are where they belong.

These synthetic substances are also known as bath salts or, in the case of synthetic marijuana, Spice incense. Synthetic drugs aren't sold on street corners by slingers who keep hidden stashes; instead, these drugs are legal--even though they are dangerous--and can be found in local corner stores across the country. They are as easy to buy as a lollipop or a carton of milk but far more dangerous, even more dangerous than the common illegal drug on which they are based.

By passing this amendment, we finally get these poisonous drugs off our shelves and keep our Nation's youth out of emergency rooms.

I wish to thank Senators Klobuchar and Grassley for working with me on this amendment, as well as Chairman Harkin and Senator Enzi, Chairman Leahy, Senator Grassley, and Senator Feinstein for their leadership, and I want to thank Senator Harkin and Enzi particularly for getting us in this package and Senator Portman for working with us on this amendment.

Eduardo Saverin

On the issue of Eduardo Saverin, last week, Senator Casey and I introduced the Ex-Patriot Act. It is a bill that makes sure that people that renounce their citizenship for tax purposes do not escape what they owe and cannot come back without repaying all that they avoided paying this great country.

It is a modest proposal, made in response to the regrettable effort by a person named Eduardo Saverin, who renounced his American citizenship to avoid paying even the historically low level of 15 percent on capital gains for the several billion dollars in windfall profit he is set to receive from the Facebook IPO.

Mr. Saverin is no longer involved in the day-to-day running of the company, and it bears mentioning that the current, active leadership of Facebook is comprised of responsible corporate citizens who meet all of their responsibilities and obligations.

Mr. Saverin, on the other hand, has chosen to disown the United States to save some money on his taxes.

Senator Casey and I have proposed a response. Our bill would bar Saverin--and others like him--from reentering the country. It would also re-impose taxes on investment income earned in the United States even if an expatriate is living abroad.

I believe that the vast majority of Americans, of all parties and persuasions, think that renouncing citizenship in America to avoid taxes is troubling, unwarranted and ungrateful.

It is upsetting, to say the least, when a person who has benefitted so thoroughly from being an American--a person who accessed and enjoyed so many exceptional aspects of American society--just takes the money and runs, rather than doing the right thing and repaying the debt he owes to a nation that nurtured, facilitated and cheered his success.

And I think that the vast majority of Americans are receptive to suggestions for how we can address this kind of unacceptable behavior.

Look, nobody enjoys paying taxes, but Americans know that we would not have a functioning society without them. We argue and debate about the proper rates, and what is fair, and what level will sustain and grow our economy and our middle class.

But I think that most Americans agree that paying a mere 15 percent in capital gains taxes on a sum of $3 billion or $4 billion is not too much to ask a person, especially a person who fled

their own homeland because their native society could not provide a reasonable level of security to their family.

While the real point here is not just about this one case--our bill addresses a small group of evaders over the last decade or so--it is worth pointing out that in this particular case the Saverin family found security here thanks to taxpayer funded cops and stability thanks to a taxpayer funded military, and a world-class university system, like that at Harvard--again underpinned by public support.

And they also found an expansive middle class that would become the market for his product. And a dynamic, entrepreneurial, free market economy that allows for significant accumulation of wealth. And functioning capital markets that were recently saved from the brink of catastrophic collapse through who? The American taxpayer.

And they found a government that invests in research and development, in things like creating the internet, and the web, and GPS, and microprocessors, all of which are necessary precursors to what Saverin and his cohorts created via Facebook.

And let's not forget, a non-corrupt legal system, which decided a case in his favor that made him a billionaire.

Yes, Eduardo Saverin did well by being in America.

And I think that most Americans know full well that what he accomplished was not done in a vacuum and that his success is the also the outgrowth of his participation in an extraordinary American society--a society that we collectively support.

No one gets rich in America on their own. And when people do well in America, they should do well by America.

I believe the vast majority of Americans believe this, too. So when I introduced our legislation I was sure it would garner wide and deep support, and in general, it has.

That is why it is baffling that extreme right wing Republicans, people like Grover Norquist, the de-facto leader of the Republican Party on tax matters, would rush to the defense of a man who is turning his back on America by dodging taxes.

Amazingly, the extreme right-wing echo chamber has made Saverin into a cause celebre, defending his decision to disown the country as somehow ``heroic''--Their words, not mine.

I was amazed. Just amazed. I took it as a given that citizenship--and all that it implies in terms of loyalty and duty to America--was axiomatic.

But that is no longer the case. Here is just some of what was said.

Forbes said that ``For De-Friending The U.S., Facebook's Eduardo Saverin Is An American Hero.'' An American hero? Renouncing your citizenship now qualifies as heroic for the hard right wing? George Washington was heroic. Rosa Parks was heroic. John McCain and Gabby Giffords are heroic. Navy SEALS are heroic. Eduardo Saverin is not.

National Review's Mario Loyola says, ``It is the foolish and counter- productive tax policies of the left that are chasing Eduardo Saverin to another country. . . .'' I'm sorry. 15 percent capital gains rate on several billion dollars is so onerous that it is chasing him away? I am sure any American worker would love to have that rate.

And if 15 percent is too high, what does Mr. Loyola or Mr. Norquist think the proper capital gains rate should be? Do they think we should have even lower taxes on capital gains, which disproportionately goes to the highest income earners?

What is the proper capital gains rate, Mr. Norquist? Should we make it 10 percent? 5 percent? Or should it be zero?

They won't say. Because if they did, they would be laughed out of town.

The Wall Street Journal says we are ``oppressive and demagogic.''

No. In America, You are free to leave. But if you leave to purposely avoid paying your fair share, then we will attach a consequence to that dodge.

Right wing blog after blog--from the American Thinker to the Daily Caller--echoes that, ``punishing Saverin for tax dodging is un- American.''

Really? Silly me. I thought that renouncing one's citizenship was un- American.

While on right wing radio they ask:

If it's a more favorable tax haven than you can find

elsewhere, why is it automatic that you are unpatriotic? Why

is it automatic that you are a coward?

Because, my fellow Americans, when you renounce your nation to fatten your bank account, you are--by definition--being greedy and unpatriotic.

Grover Norquist: says our bill is like fascist Nazi Germany or apartheid South Africa or communist Soviet Union, while in American Thinker we of erecting a ``Berlin Wall.'' And In the Examiner they are accused say we are ``totalitarian.''

The comparisons are absurd on their face and burden on the odious.

The law Mr. Norquist references in Nazi Germany was purely; discriminatory. It targeted a particular race of people--the Jewish people--and--punished them for nothing other than being Jewish and exercising freedom of movement. It was meant to constrain that freedom by forcing Jews to reside inside Germany.

Our proposal targets no single race, creed or class. It doesn't punish you for factors beyond your control, like who your parents were. It applies based on actions you take--namely, disowning the United States to avoid taxes. Our law is not triggered by a wish to travel beyond America's borders, or even reside permanently in a foreign country. It is the act of renouncing one's U.S. citizenship--for the purpose of avoiding taxes--that triggers our bill.

Another right wing opinion piece asks: ``If you leave to protest heavy taxation why must you pay a penalty?''

I am sorry, gentlemen, but Mr. Saverin is not protesting anything If he was protesting, he would stay here, and fight for a lower tax rate-- not simply exempt himself and leave others like him to continue paying a rate he considers too high. What he is doing is free-riding on America, dodging paying his fair share, and pocketing the billions from an IPO windfall.

Yet another right wing blog says we are engaged in ``class warfare to vilify people that create wealth-just like the Nazi's did with the Jews.''--I know a thing or two about what Nazi's did--some of my relatives were killed by them--and saying that a person who made their fortune specifically because of the positive elements of American society, in turn, has a responsibility to do right by America is not even on the same planet as comparing to what the Nazis did to the Jews. That comparison is odious, but it is in a bunch of these right-wing blogs.

On and on it goes. The whole torrent of vitriol is absurd. Just absurd.

Mr. Saverin is, in essence, an economic tax dodger.

And once upon a time, the right wing castigated draft dodgers for failing to heed their nation's call. Those who fled the country were vilified by the right wing as cowards, as self-absorbed, as traitors.

Yet, in this case, the exact same kind of unpatriotic, un-American behavior is actually being defended by the extreme right wing.

It is off the deep end.

And when a view this irrational has overtaken one end of the political spectrum, it has serious, negative consequences for our ability to solve our nation's problems.

If those on the other side of the negotiating table are this obsessive on taxes--that they consider their minimization a higher priority than preserving our national identity--then it is no wonder a grand bargain on taxes and spending has been so out of reach.

In the last several years, the far right has disregarded one historically conservative priority after another in favor of an all- consuming obsession with protecting low tax rates for the wealthiest Americans.

First, it was the deficit. The Republicans have for years claimed that deficit reduction was their top priority. But that has since been exposed as a myth.

Every independent economist will tell you that the deficit problem cannot be solved except through both spending cuts and revenue increases. In fact, preserving tax cuts for the very wealthy is counterproductive to the goal of reducing our annual deficits.

Yet the far right marches on in defense of tax cuts for millionaires, deficits be damned.

Last August, our Nation's creditworthiness became a second casualty of the far right's insistence on low taxes for the wealthy. The right wing was so dug in against any reasonable fiscal

compromise that they forced a manufactured crisis over raising the Nation's debt limit. This caused the first-ever downgrade of our Nation's credit rating.

Unbelievably, the far right prioritized millionaire tax breaks over our Nation's full faith and credit.

Despite that unreasonableness, we thought we had finally figured out a way to force the far right to come to grips with the need to deal with revenues. We come up with a mechanism called the sequester that would trigger harsh defense cuts if the Republicans continued to refuse any new revenues.

Surely, if there was one thing conservatives prized as much as tax cuts, it was defense spending, right?

Wrong. As we speak, the far right remains unwilling to cede an inch on revenues, no matter what it means for the Pentagon. The deficit; the Nation's creditworthiness; National security--all of these have taken a backseat to the far right's idolatry on taxes. Now they have gone so far, they have taken this idolatry all the way to its extreme end point by making Eduardo Saverin into their patron saint.

In the name of low taxes for the wealthy, they have lionized an inherently unpatriotic person.

The hero worship of Saverin is Norquist's extreme right wing anti-tax agenda being carried to its logical conclusion. And it is a scary, absurd place where even a tax dodger who renounces America for his own 30 pieces of silver is celebrated as a patriot and an American hero.

It is perverse.

Reasonable Republicans rightly seem wary to embrace taking things this far. House Speaker John Boehner labeled Saverin's move ``absolutely outrageous'' and said he would support legislation to stop wealthy ex-pats relocating to avoid taxes.

Others have been quiet, perhaps cowed by fears of being the next target of the right wing echo chamber.

Shouldn't loyalty to America--and the broader responsibilities and duty of citizenship--trump base, non-essential financial self-interest?

Sadly, the answer of the extreme right is no.

The Wall Street Journal attacked the thrust of our proposed legislation as an example of the ``age of envy.'' Well, it is not envy. In fact, I am happy those who intended and invested in Facebook got very rich. Having an idea and succeeding and maybe getting rich off this great idea is the American way. More power to them.

However, what is not the American way is taking a free ride on all the exceptional aspects of American society. What is not the American way is deriving massive advantage from various publicly supported elements of that society and then skipping town when you hit the jackpot. Yes, you are free to leave. You have a right to be selfish-- even greedy--when renouncing this Nation.

I understand this will make you more money and there is a rational, simplistic argument to be made in favor of doing it--if the only factor that mattered was always getting richer and all other values were irrelevant. But we Americans have other values too.

America is special for many reasons. It is secure, it offers freedom of expression, it is diverse and tolerant, it is entrepreneurial, and it is economically and culturally dynamic. Looking out for the common good is in our blood. It is a part of our shared history and vision of our Founding Fathers.

We provide for the common defense. We promote the general welfare. We are not just out for ourselves. No. We look to secure the blessings of liberty not just for ourselves but for our posterity. It is this, and so much more, that makes America an exceptional society.

I am appalled by the reaction. I am not appalled by a debate on tax policy. I am appalled by making heroic a man who renounces his citizenship to escape a tax rate, capital gains of 15 percent.

Too often I think every action and dilemma we face is now reduced to a question of whether this means bigger government or smaller government. Since those on the extreme right believe we must have smaller government at all costs, they vehemently oppose all taxes. But sometimes, as with this case and others like it, it is not just about the size of government. It is about doing what is fair and right and just based on your responsibilities as a citizen.

Citizenship is not simply a business decision, it is not just a transaction. Those on the right, such as Grover Norquist, defending this economic draft dodger are saying something very different. They are saying the social contract somehow excludes the accumulation of money. We know we give up certain rights and freedoms to live in a place like America, but we cannot just carry out vigilantism to pursue justice.

So in conclusion, being an American is not a one-way street. There are enormous benefits to being a citizen of our Nation and a member of the amazing society that has spawns. But there are also responsibilities and duties, such as patriotism, service, contributing your fair share, and commitment to community and family.

As we approach critical debates on the matters of taxation and fairness and job creation so critical to keeping America, the greatest Nation on the face of the Earth, I certainly hope it is these values, not glorified self-interest, that drowns out all other values that guide our actions.

Thank you. I yield the floor.

Sen. John McCainR-AZ · May 24, 2012

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. I ask unanimous consent to call up amendment No. 2107 and make it pending. Mr. President, I ask unanimous…

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

I ask unanimous consent to call up amendment No. 2107 and make it pending.

Mr. President, I ask unanimous consent that the reading of the amendment be dispensed with.

Mr. President, this is not a new issue. This has been before this body on several occasions. I want to assure my colleagues that if the lobbyists for the pharmaceutical companies in this town are able to block this, we will be revisiting this issue. This is an issue of fundamental fairness and decency and giving Americans the opportunity to have access to very important medication that in many cases is lifesaving. It has been blocked by one of the most powerful lobbies in Washington, that of the pharmaceutical companies.

For years, along with many other Senators and the current occupant of the White House--the President of the United States, when he was a U.S. Senator, supported this amendment. I would love to see the administration weigh in and take the same position that then-Senator Obama took on this issue of basic and fundamental decency and fairness to people who are badly in need of medicine to, in many cases, literally save their lives.

Industry opponents of the comprehensive importation proposals have found various ways to confuse the issue, raise red herrings about safety, or cut secret deals to block passage of reasonable and widely supported prescription drug importation programs.

Let me give an example--this recently came up--of the activities of the pharmaceutical companies in the formulation of ObamaCare. ``GOP probe uncovers deal between Obama and drug companies,'' by Philip Klein, the senior editorial writer of the Washington Examiner.

Three years ago, President Obama cut a secret deal with

pharmaceutical company lobbyists to secure the industry's

support for his national health care law. Despite Obama's

promises during his campaign to run a transparent

administration, the deal has been shrouded in mystery ever

since. But internal emails obtained by House Republicans now

provide evidence that a deal was struck and GOP investigators

are promising to release more details in the coming weeks.

What the hell?'' White House Deputy Chief of Staff Jim

Messina, who is now Obama's campaign manager, complained to a

lobbyist for the Pharmaceutical Research and Manufacturers of

America (PhRMA) in January 15, 2010 email. ``This wasn't part

of our deal.''

This reference to ``our deal'' came two months before the

final passage of Obamacare in an email with the subject line,

``FW: TAUZIN EMAIL.''

At the time Billy Tauzin was president and CEO of PhRMA--

And I might add, one of the highest paid lobbyists in history, millions of dollars--

the e-mail was uncovered as a part of Obama's closed-door

health care negotiations that was launched by the House

Energy and Commerce Committee oversight panel:

``In the coming weeks the Committee intends to show what

the White House agreed to do as part of its deal with the

pharmaceutical industry and how the full details of this

agreement were kept from both the public and the House of

Representatives,'' the committee's Republican members wrote

in a memo today.

On June 20, 2009, Obama released a terse 296-word statement

announcing a deal between pharmaceutical companies and the

Senate that didn't mention any involvement by the White

House.

``The investigation has determined that the White House,

primarily through Office of Health Reform Director Nancy Ann

DeParle and Messina, with involvement from Chief of Staff

Rahm Emmanuel, was actively engaged in these negotiations

while the role of Congress was limited,'' the committee

members wrote. For example, three days before the June 20th

statement, the head of PhRMA--

That is Mr. Tauzin--

promised Messina, ``we will deliver a final yes to you by

morning.''

Meanwhile, Ms. DeParle all but confirmed that half of the

Legislative Branch was shut out in an e-mail to a PhRMA

representative: ``I think we should have included the House

in the discussions, but maybe we never would have gotten

anywhere if we had.''

What went on in the formulation of ObamaCare is still one of the worst, sleaziest exercises I have seen in my many years here, and this involvement by the pharmaceutical companies was probably the most egregious. All this amendment does is allow U.S. consumers who need more affordable prescription drug options to either go without their medications or pay higher prices than they could get from legitimate Canadian pharmacies. But that is not a reason. It is not a reason for us to stop fighting for those in the United States who need more affordable prescription medications.

There are Americans in this country today who cannot afford their medications. They have a choice between eating or taking their prescription drugs. Meanwhile, there is a way for them to get much cheaper drugs, and this amendment does that.

We will hear from the pharmaceutical company supporters in the Senate who will talk about safety and how Canadians don't have the same standards we do. Really? Do we really believe the Canadian regulations and oversight are any better or worse than the United States? To ensure that U.S. patients have at least one option, this amendment takes a very narrow approach to safe importation by focusing on legitimate Canadian pharmacies.

Under this amendment the Secretary of Health and Human Services will certify ``approved Canadian pharmacies'' based on certain safety and quality criteria. To ensure that patients are not exposed to unsafe medications ``approved Canadian pharmacies'' can only sell drugs to U.S. customers that are the same as U.S. approved drugs. To protect U.S. patients against rouge distributors, a list of approved Canadian pharmacies must be published by the Secretary of Health and Human Services so Americans know which Canadian pharmacies are legitimate.

The cost of health care, including prescription drugs, continues to increase. However, there is nothing in the underlying FDA bill that will bring down the cost of prescription drugs. I wonder if the bill should be enacted when it doesn't do anything to address costs. The quality of pharmaceuticals in this country is outstanding, and I recognize that. But don't we all know how expensive it is?

For example, don't we know that in the United States of America, Nexium, 20-milligram, 30 tabs, is $195.99. The Canadian brand is $108.55, and Canadian generic is $69. For Plavix, the U.S. brand is $195; the Canadian brand, $132.

I am sure many Americans whose health coverage does not include these very expensive pharmaceuticals would be eager to take advantage of the same quality brand of prescription drugs that are available at these pharmacies in Canada.

As we all know, unemployment remains over 8 percent, and millions of families have mothers and fathers who remain unemployed or underemployed and have no health insurance coverage. But the unemployed and uninsured still have health conditions, and they need medications. Millions continue to search for more affordable ways to get their needed prescription drugs.

Unfortunately, in my State many of my fellow citizens who cannot afford it go to Mexico to get drugs, and I cannot guarantee what they purchase there will always be what it is purported to be. That is not a criticism of my friends south of the border. But the fact is in Canada they have the same kind of process we do. Despite there being no official program to import medications from Canada, approximately 1 million U.S. consumers use

their own money to safely get their medications from legitimate Canadian pharmacies.

In Arizona, over 20,000 patients purchase their medications safely from Canadian pharmacies. In Florida over 85,000 patients purchase their medications safely from Canadian pharmacies. A recent study from Roger Bate, an AEI scholar, confirms that in drugs dispensed from legitimate Canadian pharmacies there was no failure of authenticity between drug samples obtained online from U.S. pharmacies compared to the same drug from Canadian pharmacies. Within the verified pharmacies U.S. prices on average were 52.5 percent higher than Canadian pharmacy prices. In other words, the drugs from Canadian pharmacy sites are the same dosage, form, and potency as drugs in the United States, only much less expensive.

The drugs are the same as I mentioned. This amendment doesn't authorize insurance companies, huge pharmacy chains, or drug wholesalers to import massive quantities into the U.S. system. This is about safely allowing uninsured, unemployed, and the underemployed to individually import these drugs they need.

So, please, somebody explain to me how we tell the struggling family who needs their medications that they cannot use their own money to get the same drug from legitimate Canadian pharmacies where the costs can be more than 50 percent lower than U.S. prices. It is not about the alarms of safety because this amendment requires the Secretary of Health and Human Services to promulgate regulations permitting individuals to safely import medications from Canada, and the following safety criteria must be met for a patient to import drugs from FDA- approved Canadian pharmacies: The prescribed drug must be dispensed by a licensed Canadian pharmacist; the prescribed drug must be for personal use in quantities that don't exceed a 90-day supply; the prescribed drug must be dispensed in accordance with a valid prescription issued by a physician licensed to practice in the United States; the imported drug must have ``the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved by the Secretary.''

The amendment recognizes that approved Canadian pharmacies meeting safety criteria can and should provide needed alternatives to U.S. patients using their own money to affordably obtain their medications. The Secretary is required to publish on the FDA Web site a list of ``approved Canadian pharmacies'' that meet the following stringent criteria: The pharmacy has been in existence for 5 years prior to enactment of the program and has a purpose other than to participate in the U.S.-Canadian safe drug importation program; the pharmacy operates in accordance with provincial pharmacy rules and regulations; the pharmacy complies with all inspection and data reporting procedures; the pharmacy agrees that labs approved by the Secretary shall be used to conduct product testing to determine the safety and efficacy of sample pharmaceutical products; the pharmacy does not resell products from online pharmacies located outside Canada to consumers in the United States.

Safe drug importation is a bipartisan issue. People in all of our States are still struggling with family budgets, and the Senate cannot do anything to give patients more choices about where they can get their needed drugs because the drug industry opposes allowing individual Americans to use their own money to safely get the same drugs from Canada, and it doesn't make sense.

Just a word about the types of medications that are eligible. I have been asked by colleagues whether biologic medicines can be part of the program. The answer is not unless they can be safely imported under the provisions of the amendment and regulations issued by the Secretary.

The amendment doesn't discriminate against the type of conditions or medicines that patients should be able to safely import under this program. Not all biologics are the same. Some biologic medicines are available in capsules; others are injectable medications that require refrigeration. Some injectables don't require refrigeration and are shipped to patients throughout the United States every day.

I don't believe U.S. patients should be necessarily prevented from saving money on biologics. If a biologic medicine cannot meet the various safety provisions in the amendment, it should not be eligible. If it can meet the requirements of the amendment, then a biologic can be available to U.S. patients.

If the past is a prologue, then obviously this amendment will go down. Then after this amendment is rejected, I hope none of my colleagues have any curiosity about the way the American people feel about us; about the incredible, inordinate, illegitimate, outrageous influence of the pharmaceutical companies in America over the average American citizen. American citizens should be able to purchase pharmaceuticals from an approved pharmacy in Canada that many times is saving them half the money.

I am sure the distinguished chairman, my friend from Iowa, knows how many families do not have prescription drug coverage who are making a choice today between eating and medicine. What are we going to do? We are going to turn down this commonsense amendment.

Congratulations ahead of time to the corrupt pharmaceutical companies and their influence in the United States Senate and Capitol.

Mr. President, I ask for the yeas and nays on the amendment.

Mr. President, I suggest the absence of a quorum.

Mr. President, this amendment is a simple one. It creates a safe individual drug importation program only from approved Canadian pharmacies, overseen by the Secretary of Health and Human Services.

In a normal world, this would probably require a voice vote. But what we are about to see is the incredible influence of the special interests, particularly PhRMA, here in Washington, where people who cannot afford it will have to make a choice between eating and medicine. They will not be allowed to purchase a medication at less than half the price, many times, than they will in American pharmacies in Canada.

So what you are about to see is the reason for the cynicism the American people have about the way we do business in Washington. PhRMA--one of the most powerful lobbies in Washington--will exert its influence again at the expense of average low-income Americans who will, again, have to choose between medication and eating.

Sen. Olympia J. SnoweR-ME · May 24, 2012

Mr. President, I rise to speak in support of the amendment offered by the Senator from Arizona. Nuclear Submarine Fire Before I do that, I want to recognize and acknowledge the tremendous and…

Mr. President, I rise to speak in support of the amendment offered by the Senator from Arizona.

Nuclear Submarine Fire

Before I do that, I want to recognize and acknowledge the tremendous and outstanding and remarkable work done by the crew at the Portsmouth Naval Shipyard and the local firefighters from numerous departments from the State of Maine, as well as from New Hampshire, because of the fire that occurred on the nuclear-powered submarine at the shipyard last evening, which was burning for more than 9 hours.

It was the extraordinary teamwork and coordination among all of the crews, as well as the firefighters and departments from both States, that managed to put out the fire. It is now smoldering. I offer my commendations and congratulations to those who did the exceptional and outstanding work, which exemplifies the kind of teamwork that already occurs at that shipyard. I wanted to offer my recognition to that extraordinary work in a very difficult circumstance.

Amendment No. 2107

I rise in support of the amendment offered by the Senator from Arizona, Senator McCain, in authorizing a very limited drug importation program, whereby Americans can purchase medications from accredited online Canadian pharmacies. I am supporting this amendment, as I have in the past. In fact, we have had broader amendments offered on the floor of the Senate for almost more than a decade with respect to allowing importation of prescriptions from other countries that offer more competitive prices.

I applaud Senator McCain, who obviously has been a very valuable ally in

this effort for many years. But he proposed a very limited approach to address those who have concerns with the idea of importing prescription drugs. I, for one, cannot understand why there is such a fundamental concern about this issue because, first of all, Americans have been facing tremendous increases in prescription drug prices for far too long. I think it is at a point at which Congress should address this issue, and precisely on this particular piece of legislation that is before us today. It could not be more appropriate to have this amendment offered on this legislation.

In 2010, AARP found that retail prices for the most popular brandname drugs increased 41.5 percent, while the Consumer Price Index rose just 13 percent. In other words, the cost of prescription drugs rose more than three times as much as the inflation rate. That is completely unacceptable.

What has occurred as a result of this trend? First of all, American consumers are increasingly choosing to risk living without taking critical medications. According to the Commonwealth Fund, in 2010, 48 million Americans did not fill a prescription due to high costs. That represents an increase of 66 percent since 2001.

If the Senate and the overall Congress were to adopt the McCain amendment, it would allow Americans to purchase safe medications at a lower price than they are available for us in this country. We could begin to turn this disturbing trend around. I know people in Maine deserve access to affordable drug prices. Millions of Americans, and certainly those in Maine, have purchased drugs from Canada safely, at a significant savings over the years. They have had to go to great lengths in order to purchase lower price medications. They have taken bus trips to Canada to purchase that medication because that was the only way they could have access to the prescriptions they so desperately need. The McCain amendment builds on that foundation.

If we look at this first chart, Mr. President, an April 27, 2012, survey comparing average Canadian drug prices against major U.S. retail pharmacy prices, we find the average U.S. price for a 90-day supply of Nexium, which is a common blood thinner, is $560 in America but only $265 in Canada. So Americans are paying twice as much for Nexium as Canadians do. I think that is simply outrageous. Why should American consumers pay twice as much for a medication that so many Americans depend upon?

Here is another example of a drug that is a blood-thinning drug that is also very crucial in this process, and that is Plavix. That costs $585 in the United States versus $398 in Canada for a 90-day supply. So, again, American consumers are paying 50 percent higher costs for the same prescription drugs as Canadians do.

Then let's look at the very popular anticholesterol medication Lipitor. This chart illustrates, again, what Lipitor costs the American consumer. The cost is $478 in the United States as compared to $278 in Canada for a 90-day supply.

So for patients who are already trying to make ends meet in this very difficult economy by rationing their medications, splitting their pills, or even skipping medications entirely, why would we deny them access to safe drug products at these dramatically lower prices? That is why I have cosponsored Senator McCain's amendment. It would allow Americans to import medication from accredited Canadian pharmacies from a list approved by the Secretary of Health and Human Services. These accredited pharmacies must commit to ongoing quality assurance programs and product testing to determine the safety and efficacy of these products.

This amendment is more narrowly focused than even the one that our former colleague Senator Dorgan and I had offered previously. This provides a pathway to a more limited approach for Americans to access affordable medications. In fact, there has been a very recent study conducted by Roger Bate of the American Enterprise Institute entitled ``Unveiling the Mystery of Online Pharmacies: An Audit Study.'' Let me quote from him as to what he discovered:

If some foreign Web sites sell safe prescription drugs with

substantial price discounts, but American consumers are

guided to buy from U.S. Web sites only, the FDA could

potentially discourage price competition between the U.S. and

foreign pharmacies and, thereby, reduce drug affordability

within the United States. The danger of reducing price

competition depends on whether consumers can distinguish

trustworthy Web sites from the vast pool of foreign Web

sites.

So here we have the documentation by a very significant study that talks about how Americans can access these affordable medications. We shouldn't be discouraging price competition, as this study illustrates. That is one of the points I have been arguing over the years; that the real problem in this country with respect to prices for prescriptions is that we don't have competition within the industry and competition for those medications.

Americans have learned that citizens in other countries use the very same medications as we do. They are made in the very same plants. Yet they pay less. We talk about injecting greater free market competition in the health care marketplace as a way of achieving greater affordability, and this amendment attempts to address that very issue. As we look at what other countries do, when we are talking about accessing cheaper medications, we know in Canada that is the case, and it is certainly true in other industrialized nations.

I should add, in fact, they pay 35 to 55 percent less for their drugs because of the higher prices Americans pay, which is about $90 billion more for prescription drugs every year than we would otherwise. I think that is totally unacceptable. Why should American consumers be paying 35 to 55 percent more or nearly $90 billion more than consumers in other countries for the very same medications? It simply doesn't make sense.

According to former Pfizer CEO Hank McKinnell--looking at the quote on this chart:

Competition is good medicine for economies. . . . Name an

industry in which competition is allowed to flourish--

computers, telecommunications, small package shipping,

retailing, entertainment--and I will show you lower prices,

higher quality, more innovation, and better customer service.

There's nary an exception. Okay, there's one. So far, the

health care industry seems immune to the discipline of

competition.

When we last considered the legislation I introduced along with former colleague Senator Dorgan, we allowed importation only from Canada, the European Union, Australia, New Zealand, and Japan, and the Congressional Budget Office estimated the Federal Government would save almost $20 billion--$20 billion--if we allowed the importation of those medications. So we know for a fact allowing drug importation generates considerable cost savings to the government, to individuals, and businesses that provide health insurance coverage to their employees.

The bottom line is where nations institute safe, regulated trade in pharmaceuticals they achieve results. When Sweden entered the European Union system of trade, they saw a reduction of 12 to 19 percent in the price of traded drugs. In fact, Europe has had parallel trading for more than 30 years and has never had an incident.

Industries see the advantage in being a part of the global market when it comes to manufacturing costs. For example, according to a Pew study in 2011, the number of prescription drugs made at non-U.S. sites doubled between 2001 and 2008. That means they doubled at a sizable increase with respect to the number of prescription drugs that are made at non-U.S. sites. There are more than 50 plants where our medications are manufactured, and not all of those facilities are even inspected-- not even inspected. Yet those are medications we use in this country because they are manufactured at other plants in other countries. As I said, there are more than 50 countries in which we have our prescriptions manufactured.

So let me see if I have this straight. It is fine for some foreign countries to manufacture drugs in their own plants for the U.S. market, ship those drugs here where the American people are given the privilege of paying higher prices than anywhere else in the world, but somehow we can't safely import those very drugs into the United States directly. It simply doesn't make sense.

The American taxpayer is underwriting more than $30 billion of research--basic and applied research--at the National Institutes of Health alone, so consumers in all those other

nations are benefiting from the investments the American taxpayer is making with respect to research. That U.S. research produces these medications and these prescriptions that other nations pay 35 to 55 percent less for than the American consumer. The American taxpayer is paying more for those drugs, as I said, and also paying more of their tax dollars for the research that is ongoing at the National Institutes of Health. It simply doesn't make sense.

With all of the additional profit, industry invests nearly equally in R&D in the United States and in Europe and is increasingly moving research to low-cost Asian countries. So paying the world's highest prices for drugs doesn't ensure us more research, but it decreases our access to drugs. So that is the contradiction that Americans confront each and every day when they are purchasing their medications at a much higher cost than consumers in other countries.

The amendment that is offered by the Senator from Arizona is allowing importation solely from Canada, and it is for online pharmacies based on a list that has been drafted by the Department of Health and Human Services. That is a very prescribed, targeted, limited approach to allowing American consumers to benefit from those lower priced drugs that are offered in Canada.

It is very important we take this step. It is important for American consumers who otherwise are not going to be able to afford these medications when they are paying two to three times more than their counterparts in Canada, for example. The prices are rising five times more than the inflation rate year after year, so the compounding effect is significant and overwhelming for most American consumers and families. So what I hope is we will support the amendment that has been offered by Senator McCain.

Some have suggested that providing support for the McCain amendment will hinder efforts to quickly move on the underlying legislation for the FDA. That concern is certainly not persuasive because the McCain amendment is a very narrowly focused approach. It represents a good- faith effort to find common ground. It has included strong safety- related measures and is done under very limited circumstances so the American consumer can take advantage of the lower prices I have demonstrated today with regard to some of the commonly used drugs, such as the anticholesterol medication Lipitor and the drug-thinning drugs such as Plavix. It is explicitly designed to make it more broadly acceptable to those who might have concerns in taking the approach of drug importation.

We must create a more competitive, more affordable health care system for the American people. The prescription drug market needs competition. Competition will lower prices. For some reason, even though we are underwriting all of the research that benefits consumers in so many other countries, and even though our medications are manufactured at other plants in 50 countries, the American consumers are paying up to 55 percent more than their counterparts around the world. It simply doesn't make sense. In fact, I would suggest it is outrageous.

So that is why I am supporting this amendment. We need to take this limited, modest first step that I think goes a long way to addressing any reservations anyone might have in this Chamber with respect to the issue of importation. I hope we will allow American consumers to benefit from the much lower prices, especially during these very difficult economic times. This is a first step toward a larger system of safe, regulated drug importation.

I commend the Senator from Arizona for offering this amendment, and I hope the Senate will adopt it.

I yield the floor.

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Reported to SenateIssued July 28, 2011

Calendar No. 120

112th CONGRESS

1st Session

S. 409

IN THE SENATE OF THE UNITED STATES

February 17, 2011

Mr. Schumer (for himself, Mr. Kyl, Mr. Kohl, Mr. Sessions, Mrs. Feinstein, Mr. Whitehouse, Ms. Klobuchar, Mr. Franken, Mr. Blumenthal, Mr. Brown of Ohio, Mr. Casey, Mr. Lautenberg, Mr. Manchin, Mr. Wyden, and Mr. Leahy) introduced the following bill; which was read twice and referred to the Committee on the Judiciary

July 28, 2011

Reported by Mr. Leahy, without amendment

A BILL

To ban the sale of certain synthetic drugs.

Short title

This Act may be cited as the Combating Dangerous Synthetic Stimulants Act of 2011.

Controlled Substances Act

Schedule I of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended in subsection (c) by adding at the end the following:

(18)

4-methylmethcathinone (Mephedrone).

(19)

3,4-methylenedioxypyrovalerone (MDPV).

July 28, 2011

Reported without amendment