Synthetic Drug Control Act of 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 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.

My colleagues, this reauthorization of the FDA's user fees will provide stability for the FDA's new product review as companies submit new and innovative drugs, medical devices, and biologics for approval.

I am especially proud that my bill, the Faster Access to Specialized Treatments, H.R. 4132, FAST, was included in the FDA Reform Act. FAST modernizes the FDA's accelerated approval pathway to reflect scientific developments that have occurred over the past 20 years. This will allow for new drugs for people suffering from rare diseases. There are 30 million Americans suffering from one of over 7,000 rare diseases, but only 250 currently have any treatment. FAST will save lives.

I am pleased also that the bill includes the EXPERRT Act, H.R. 4156. This will help the FDA consult with medical experts when evaluating drugs designed for rare diseases, such as cystic fibrosis. As the cofounder of the Cystic Fibrosis Caucus, I am glad we are finally providing this tool to the FDA.

I obviously support the passage of this bill.

Mr. Speaker, the Food and Drug Administration Safety and Innovation Act (S. 3187) is based on user fee negotiations between FDA and the prescription drug, generic drug, biologic, and medical device industry. This reauthorization of the FDA user fees will provide stability with FDA's new product review as companies submit new and innovative devices and drugs for approval.

This bill is the result of hard work and negotiations between industry and FDA, and the hard work between Republicans and Democrats, and between the House and the Senate. This bill is a true bipartisan, bicameral bill that will serve the American people well.

In codifying the User Fee Agreement, this committee has included additional provisions designed to address some of the defects of the regulatory structure and overreach by the FDA. Under my Chairmanship of the Oversight and Investigation Subcommittee, we held a hearing into FDA's regulatory efforts in the medical device space. During our hearing, many of the witnesses talked about the reluctance of FDA to approve devices and how FDA continually moved the goalposts for approval. I am glad that Title VI of this bill includes a significant number of reform provisions designed to bring certainty to the medical device field.

In addition to reforming approaches to medical devices through Title VI, the FDA's approach to rare diseases must also be modernized.

I want to take this opportunity to thank Dr. Emil Kakkis, Julia Jenkins, Harry Sporidis, Tim Perrin, Steve Stranne, everyone at the EveryLife Foundation for Rare Diseases, Pat Furlong, Nick Manetto, everyone at the Parent Project Muscular Dystrophy, and the other 150 rare disease groups that supported FAST and ULTRA. In 2011, I met with Dr. Kakkis who introduced me to two parents who had children with rare diseases and limited options as most rare diseases do not have treatments. One parent talked about his frustration at not having any treatments, except for a drug trial happening in Europe, not the United States. We talked about how we need FDA to properly address the issue of drug approval for the rare disease community, which led to examining the Accelerated Approval pathway and trying to modernize it. We developed the Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA, H.R. 3737), which I introduced with my friend and colleague, Rep. Ed Towns, to nudge the FDA into using Accelerated Approval for rare diseases.

However, after further review of the law, FDA's history of usage of Accelerated Approval and the feedback we received from stakeholders, we realized that amending the law was not sufficient. Instead, we worked with all the stakeholders to rewrite the entirety of the Accelerated Approval statute. In March, Representative Towns and I introduced the Faster Access to Specialized Treatments Act (FAST, H.R. 4132). FAST updates and modernizes Section 506 of the Food, Drug & Cosmetic Act, and updates the Accelerated Approval statute to reflect two decades worth of medical sciences that has occurred since Accelerated Approval was first created. FAST will help FDA implement broadly effective processes for the expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life- threatening diseases by using modern scientific tools.

The use of surrogate endpoints may result in fewer, smaller or shorter clinical trials without compromising FDA's existing high standards for safety or efficacy. Surrogate and clinical endpoints only need to be reasonable predictors of clinical benefit to support accelerated approval. They do not need to be validated or proven first. The changes made to current law permitting the Secretary to require validation of surrogates following accelerated approval is not intended to change FDA's long history of granting accelerated approval based on unvalidated, but predictive, surrogate endpoints.

Additionally, FAST includes explicit language for FDA to think about the challenges of rare diseases when developing their guidance and gives the rare disease community an opportunity to publically comment on FDA's draft guidance. FAST ensures that the voices of the 30 million Americans with a rare disease will be heard by FDA. There are about 7,000 rare diseases and only about 250 have any treatment. FAST will save lives, and give a voice to the voiceless; and I am glad it is in the final bill.

Lastly, the committee included the Expanding and Promoting Expertise in Review of Rare Treatments, (EXPERRT Act, H.R. 4156), a bill my fellow Co-Chairs of the Cystic Fibrosis Caucus and I introduced. EXPERRT will have the FDA consult with experts in rare diseases. This will ensure that FDA has access to the knowledge needed when dealing with drug approvals for diseases where FDA may lack subject matter expertise. As one of the Co-Founders of the Cystic Fibrosis Caucus, I am glad that we are giving this tool to the FDA. I also want to thank Stephanie Krenrich and the Cystic Fibrosis Foundation for all their hard work in developing EXPERRT.

I would like to submit these letters from the EveryLife Foundation for Rare Diseases and the Parent Project Muscular Dystrophy into the Record.

S. 3187 is a good bill that will help new drugs and new medicines get into the market and be available to patients. I support passage of the FDA Safety and Innovation Act.

Parent Project

Muscular Dystrophy,

Hackensack, NJ, June 20, 2012.

Hon. Cliff Stearns,

U.S. Congress, Washington, DC.

Rayburn House Office Building,

Dear Representative Stearns: On behalf of all patients and

families living with Duchenne muscular dystrophy--the most

common form of muscular dystrophy and the most common lethal

genetic condition diagnosed in childhood--Parent Project

Muscular Dystrophy (PPMD) would like to express its deep

gratitude for your efforts to include provisions of deep

interest to the rare disease community in S. 3187, the Food

and Drug Administration Safety and Innovation Act. The final

user fee reconciliation package between the House of

Representatives and Senate includes a number of measures that

will accelerate the Food and Drug Administration (FDA)

process of reviewing potential therapies for serious life-

threatening conditions like Duchenne, will ensure that the

patient voice has a seat at the table when key decisions are

made, and will incent industry to develop treatments for

pediatric rare diseases.

As you know, Duchenne muscular dystrophy exemplifies the

challenges faced by many patients and families afflicted by

rare diseases. It is a fatal condition with most patients not

living past their late 20s, and the only approved therapies

are steroids, which cause significant complications long-

term. With nearly 20 potential therapies in various stages of

clinical trials, our community is hopeful that better times

are ahead, and we recognize that a more efficient FDA attuned

to the needs of the rare disease patient population is

critical to our success. Again, we are most appreciative of

your efforts to ensure that the above mentioned provisions

were included in the final legislation. On behalf of Duchenne

and the broader rare disease community, thank you for your

leadership and support.

Sincerely,

Pat Furlong,

Founding President and CEO.

I appreciate the gentleman from Virginia for yielding the time.

I rise in opposition to this particular bill. It's not that I am, indeed, in favor of any of the particular drugs that are here; but just like Mrs. Adams, my colleague from Florida mentioned, the State of Florida has already criminalized it, as many States have, and it's really a State issue.

It seems interesting. When the subject du jour comes up, the item of the day, there is a rush to action and a rush to forget States' rights. There is a desire on gun bills to overlook the States and to have a Federal law on the interstate shipment of guns or on the interstate transportation of guns by people with permits. In this situation, drugs that should be criminalized are criminalized at the State level, but all of a sudden we're doing it more at the Federal level.

This bill would place more than 40 chemical compounds on Schedule I, the most punitive and restrictive schedule, without any independent scientific evidence that doing so is necessary or warranted. It is a rush to legislate before we know all the facts.

This bill essentially bans these substances without any study whatsoever. I've read the press reports of young people who have been harmed by these substances and by others, and I'm very sympathetic as that's certainly wrong; but we shouldn't legislate on the basis of anecdotal evidence. It's typical of the ``shoot first and ask questions later'' approach that we have taken to drug policy in this country for decades.

Our national drug policy should be driven by science, not politics. We've already gotten a well-deserved reputation here as a do-nothing Congress; but bills like this and our attitudes towards clean air, clean water, global climate change, and other environmental issues have made this the no-respect-for-science Congress as well.

The DEA has already taken steps to temporarily place certain synthetic substances on Schedule I while it conducts a review. If there is an emergency that requires temporarily scheduling the other substances in this bill, the DEA can review them and do that just as well.

But we shouldn't circumvent the process established in law. I don't think this is a responsible way to legislate. I know the sponsors of this bill know about the emergency review process because the bill doubles the length of time a bill can be put on emergency review on a schedule from 18 months to 3 years; it doubles it. Yet there's been no hearings or evidence that 18 months was insufficient, none whatsoever. It was just a knee-jerk way to respond to the issue du jour.

This is a very serious issue and deserves serious study and consideration before we act, as all bills before Congress should. I fear that this bill continues the misguided policies that we've created towards drugs in this country.

Just look at our experience with marijuana, which Congress placed on Schedule I in 1970. According to the criteria of the Controlled Substances Act, it supposedly has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug under medical supervision.

Let's put aside for a minute the question of whether it has a potential for abuse. Certainly there's a lot of evidence that it does not. But I think thousands of people who depend on marijuana to treat the effects of such diseases as AIDS, cancer, glaucoma, and multiple sclerosis would take issue with the notion that it has no medical use, and 15 or so States have legalized it for medical use. It increases appetite and eases pain in a way that has helped countless people in the last stages of life.

But we treat our approach to drugs as a law enforcement matter, not a scientific matter, and we've placed marijuana in Schedule I, the most restrictive schedule. Meanwhile, the scientific community is urging that we reschedule marijuana so we can continue to conduct important research and make it available to those in need.

Recently, the California Medical Association called for cannabis to be legalized and regulated, primarily so

that scientists can gain access to it and conduct further research. They advocated wider clinical research with accountable and quality- controlled production of cannabis. None of this can happen with the tight restrictions we've placed on cannabis. That's exactly the situation we may find ourselves in with the substances named in this bill.

I know that licenses are available for research in the Schedule I drugs, but there's no reason to make researchers go through such hoops. It is nearly as easy to get permission to do research on a Schedule I drug as it would be to go to the Vatican and ask for a grant to study birth control.

We don't know what medical benefits these substances may contain and we don't know the true risk they pose. Perhaps they belong in a lower schedule. And Schedule II would certainly deter young people from using them and others and set a penalty stage. But we have no idea. We just decided to throw the book and make it Schedule I.

Perhaps they shouldn't be scheduled at all. I suspect they should be scheduled, maybe Schedule II. But the scientists should decide this and not politicians. We have no basis to believe they belong in Schedule I. Haven't we learned from this Nation's 40-year experiment with the war on drugs?

Prohibition does not work. It is an expensive and counterproductive policy that fills up our prisons and places a mark on our citizens that can make jobs, housing, and education nearly impossible to obtain. We should focus our efforts on educating young people about the substances and continue to do research about their benefits and risks.

Instead of basing our drug policy on science, we are letting it be driven by politics. This bill continues that trend, and regrettably I must urge its defeat. We need to send this bill back to committee and take a careful, considerable review so that we can have Congress make this decision on a scientific basis with help from the scientists.

The DEA can use its emergency powers to temporarily schedule these substances while letting the scientific process play out. Let's put science first and politics second. Let's defeat this bill.

If we put science first and politics second, maybe we won't be in single figures in the public's mind as an organization that they support as an institution. Part of the 9 percent level is because we do things sometimes in a rush to judgment and politics and the issue du jour rather than allowing the scientific process and doing what is logically best for our Nation to prevail.

I urge the defeat of this bill.

Mr. Speaker, I move to suspend the rules and pass the bill (S. 3187) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and insert extraneous material in the Record.

Mr. Speaker, I yield myself 2 minutes.

Mr. Speaker, I want to thank Mr. Waxman, Chairman Harkin, Senator Enzi, and Members on both sides of the aisle in both the House and the Senate who played a role in this process. S. 3187 is a reflection of the hard work put in by both Members and staff, and of everyone's willingness to put partisanship aside to look at the issues together. Because of that outstanding dedication, we have a bill today that will make a real difference in the lives of so many patients and provide much-needed support for innovators across our great country.

At the outset of this Congress, I set a goal of enacting this bill by the end of June--and here we are, well before the clock expires for this month--in order to provide certainty for American patients and innovators. I never lost confidence that we could deliver the bipartisan reforms we needed, and I am so proud that we will accomplish that goal.

Mr. Speaker, this is a jobs bill, and it's a medical innovation bill. And as we put this package together, our goal was to improve the predictability, consistency, transparency, and efficiency of FDA regulation. These reforms will help get new treatments to patients more quickly. They will help us not only keep jobs in Michigan and all across the country, but also to create new ones. In order to get it right, we turned to patients, innovators, and job creators who provided firsthand experience of how the current system is broken. And we included many of their suggestions in the bill.

This bill includes significant accountability and reform measures designed to hold the FDA responsible for its performance. The measure includes independent assessments of FDA's drug and device review process. It also includes requiring quarterly reporting from the device center so we don't have to wait a year to find out FDA's progress. The bill is about patients, and that's why so many patient advocates have spoken out in support of these reforms. Whether it is steps that we took to support treatments for rare diseases or mitigate drug shortages or speed up the approval of devices that will improve a patient's quality of life, these are steps that will make a real and significant difference.

They're going to keep the U.S. at the forefront of medical innovation where we belong.

This bill is just the first step. This bill provides the resources and the game plans so that FDA can improve its performance.

I yield myself an additional minute.

It is now up to the FDA to execute that game plan. And I give my commitment today that our committee will continue to monitor and hold the FDA accountable for its performance. So, together, the Members of the House and the Senate have produced a bill that is a win for American patients, innovation, and job creation.

Before I conclude, I would like to recognize Warren Burke and Megan Renfrew from the Legislative Counsel's Office for their tireless work. The role of Legislative Counsel often goes unnoticed. I also want to appreciate our staff, starting with our staff director, Gary Andres, for pushing this legislation over the finish line; Clay Alspach, on the majority staff; Rachel Sher, on the minority staff; and in particular, Ryan Long, the chief counsel for the Health Subcommittee.

This bill, when it becomes law, patients will benefit from faster, newer, and better treatments, and American workers will keep us on the cutting edge of medical innovation.

I reserve the balance of my time.

Mr. Speaker, I yield 1 minute to the chairman emeritus of the Energy and Commerce Committee, the gentleman from Texas (Mr. Barton).

(Mr. BARTON of Texas asked and was given permission to revise and extend his remarks.)

Mr. Speaker, I yield 2 minutes to the distinguished chairman of the Health Subcommittee, the gentleman from Pennsylvania (Mr. Pitts).

Mr. Speaker, I yield 2 minutes to the gentleman from Texas (Mr. Burgess), the distinguished vice chair of the Health Subcommittee.

Mr. Speaker, I yield 1 minute to the distinguished gentleman from Florida (Mr. Stearns).

Mr. Speaker, I yield 1 minute to the distinguished gentlewoman from North Carolina, the vice chair of the Energy and Commerce Committee, Mrs. Myrick.

I yield 1 minute to the distinguished gentleman from Pennsylvania, Dr. Murphy.

Mr. Speaker, I yield 1 minute to a member of the committee, the distinguished gentleman from California (Mr. Bilbray).

Mr. Speaker, I yield 2 minutes to the distinguished gentleman from Georgia, Dr. Gingrey, a member of the committee.

Mr. Speaker, I yield 1 minute to the gentleman from New Jersey (Mr. Lance), a member of the committee.

Mr. Speaker, I yield 1 minute to the gentleman from Kentucky (Mr. Guthrie).

Mr. Speaker, I yield 1 minute to the gentleman from New Hampshire (Mr. Bass), a member of the committee.

Mr. Speaker, I yield 1 minute to the gentleman from Minnesota (Mr. Paulsen).

Mr. Speaker, may I ask how much time remains on each side?

Mr. Speaker, I have no further requests for time. So if the gentleman wants to close, then I will close.

Thank you, Mr. Speaker.

Mr. Speaker, I just want to say that with all of the positive comments here, this bill was not a piece of cake. There was a lot of hard work on both sides of the aisle, particularly by the staff on both sides of the aisle. Again, I want to cite Clay and Ryan on our staff.

But let's face it: All of us particularly involved on the health side of the issues, as we meet with different folks afflicted with different diseases, we want to find a cure. And it would be great to find that cure here in America because we have outstanding pharmaceutical industries that have the talent and the staff to work with the different departments, whether it be the NIH, the CDC, certainly the

Mr. Speaker, I yield myself 3 minutes.

Today, the House considers a bill that represents a significant bipartisan and bicameral achievement.

On May 30 of this year, the House passed its user fee legislation by a dramatic vote of 387 5. That bill was a strong one, but through our collaborative process with the Senate, we have made it even better.

It has been a pleasure to work not only with Mr. Upton, Mr. Pitts, Mr. Pallone, and Mr. Dingell, among many involved House colleagues, but also with our Senate colleagues, Senators Harkin and Enzi.

When we began this process, there were divergent views on the various issues contained in this bill. But we worked together and found ways to bridge our differences in a fashion that protects patients and fosters innovation.

This legislation contains many provisions that are critical to the functioning of major parts of the FDA. We reauthorize the FDA's drug and medical device user fee programs which will provide resources to enable the efficient review of applications and give patients rapid access to new therapies. We're also reauthorizing two pediatric programs which foster the development and safe use of prescription drugs in children.

This year, we're establishing two new programs to help the FDA speed up their review of new generics and biosimilars. These provisions illustrate our bipartisan commitment to ensuring a vibrant generic marketplace. All

of us will see the benefits when more low-cost generics are on the market.

One of the most important improvements to the House-passed bill is in the area of antibiotics. We accepted the Senate language that directs incentives for the development of antibiotics toward serious and life- threatening infections.

This bill also includes provisions to modernize FDA's authorities with respect to the drug supply chain. Today, 80 percent of active ingredients and bulk chemicals used in U.S. drugs come from abroad and 40 percent of finished drugs are manufactured abroad. FDA has been trying to keep pace with this increasingly globalized drug supply change using an outdated statute. This legislation will give the FDA critical new tools to police this dramatically different marketplace.

We have also worked to address the area of drug shortages, which is a complex and multifaceted problem, but this legislation takes some sensible first steps.

I want to thank my colleagues on both sides of the aisle and their staffs for the hard work they've put into making this a strong bipartisan bill. I particularly want to thank Mr. Pallone and Mr. Dingell's staff members, Tiffany Guarascio and Kim Trzeciak, as well as Mr. Upton and Mr. Pitt's staff, Ryan Long and Clay Alspach.

I yield myself an additional 30 seconds.

Warren Burke and Megan Renfrew have done tremendous work on this bill. I'd like to express my appreciation for their efforts. I want to thank my own staff: Karen Nelson, Rachel Sher, Eric Flamm, and Arun Patel.

The American public will benefit from the provisions of this bill. The FDA will have the resources to remain the gold standard for the future. This is an important bill, a good one. I urge its support.

I reserve the balance of my time.

Mr. Speaker, at this time, I'd like to yield 3 minutes to the gentleman from New Jersey (Mr. Pallone), the ranking member of the Health Subcommittee, the subcommittee that was responsible for this legislation in its first instance.

I ask unanimous consent that Mr. Pallone be permitted to manage the rest of the time on our side of the aisle.