SAFE DOSES Act

I thank the gentleman from Texas for yielding me this time.

I introduced H.R. 4223, the SAFE DOSES Act, to address the problem of medical cargo theft across the United States. Medical cargo theft poses significant health risks to patients who have no reason to know that their medicines have been stolen and improperly cared for before being sold back into the legitimate supply chain.

Stolen medical cargo can kill or injure those patients that need reliable, safe medicines.

Sophisticated and enterprising criminal organizations are stealing large quantities of medical products and selling them via the wholesale market into legitimate pharmacies and hospitals. They are putting patient safety at risk because improperly cared-for medical products can be ineffective or harmful, and such damaged products are often impossible for health care professionals to identify.

High-value pharmaceuticals, including treatments for serious diseases, are frequent targets. Unfortunately, these high-value items are the very type of sensitive products that need the most careful handling and temperature control. Many medical products can become ineffective if stored at the wrong temperature, even for a brief time. Yet, under current law, the theft of lifesaving medical supplies is treated the same as the theft of perfume or stereo equipment.

The criminal organizations hijack tractor-trailers at truck stops, break into warehouses and evade alarm systems, forge shipping documents, produce high-quality counterfeit labels with altered expiration dates and lot numbers, and otherwise thwart the intense security measures used by the industry. Some employ sophisticated surveillance equipment and techniques in order to learn exactly when and where they can steal the particular shipments they want.

For example, in March 2010, over $75 million of prescription drugs, including treatments for cancer, heart disease, and neurological disorders such as depression, ADHD, and schizophrenia, were stolen from a warehouse in Enfield, Connecticut. The burglary was one of the largest pharmaceutical heists in history. The criminals broke into the secure facility on the weekend by cutting a hole in the roof, then rappelling into the storage area. They disabled the alarm system and loaded dozens of crates onto a tractor-trailer.

Experts have said that this heist shared many traits with warehouse thefts of pharmaceuticals last year in Richmond, Virginia; Memphis, Tennessee; and Olive Branch, Mississippi. Those thieves also cut through ceilings and sometimes used trapeze-style rigging to get inside and to disable the main and backup alarms. In some cases, they sprayed dark paint on the

lenses of security cameras; in others, they removed disks from the security recording devices.

This bill increases sentences for theft, transportation, and storage of medical product cargo; enhances penalties for the ``fences'' who knowingly obtain stolen medical products for resale into the supply chain; increases sentences when injury or death results from the ingestion of a stolen substance or when the defendant is employed by an organization in the supply chain; provides law enforcement with such tools as wiretaps; and provides restitution to victims injured by stolen medical products.

The legislation is supported by the Coalition for Patient Safety and Medicine Integrity, a group of pharmaceutical, medical device, and medical products companies whose purpose is to protect patients from the risks posed by stolen and improperly handled medical products reentering the legitimate supply chain. Members of the Coalition include Abbott and Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Novartis, Novo Nordisk, Sanofi, and PhRMA. The bill is also supported by the Association of Community Cancer Centers, the Healthcare Distribution Management Association, the National Council for Community Behavioral Healthcare, and the National Fraternal Order of Police.

The companion bill in the other body, Senate 1002, was reported by voice vote from the Senate Judiciary Committee in March.

I urge my colleagues to support this commonsense, bipartisan legislation to give law enforcement agencies and prosecutors the additional tools they need to confront this growing problem.

Madam Speaker, I yield myself such time as I may consume.

H.R. 4223 is intended to address the problem of large-scale medical product theft. I think we will all agree that this crime poses substantial risks to the public.

For instance, in North Carolina, in 2009, over 120,000 vials of insulin were stolen and subsequently reintroduced back into the supply chain to be used by unsuspecting patients.

Patients should be able to rely on their medications to be safe, effective, and unadulterated, and we certainly need to treat it as a significant crime when criminals steal shipments of drugs. Large-scale medical product theft is a serious problem that merits a serious solution.

I commend my colleagues on the House Judiciary Committee for making important changes to this bill. The manager's amendment adopted at markup clarified that the mens rea applies only to conduct in which the perpetrator knows that the product involved is a medical product that is stolen, expired, or not yet released to the public.

I also believe that the correct reading of this bill, consistent with the general presumption that the mens rea element in a statute applies to all other nonjurisdictional elements, is that a defendant would have to know that the product is a pre-retail medical product in order to be convicted.

While I note these important issues, I want to raise a note of concern about the approach of increasing penalties as a way of addressing crime. Stealing cargo from a warehouse is already illegal, of course. The penalty is a fine and up to 10 years in prison.

H.R. 4223 creates a new crime for theft of preretail medical products and a new code section, 18 U.S.C. Section 670. Section 670 would increase the penalties to up to 30 years in prison in some cases if the stolen goods are preretail medical products.

However, I'm heartened that this bill does not include mandatory minimum sentences, and there will be an intelligent, deliberative process to set sentencing guidelines by the U.S. Sentencing Commission.

As the House moves to adopt this bill today, I want to emphasize that it is also important that we do what we know works best to deter crime, and that is to increase the likelihood that perpetrators will be caught and convicted.

We heard from a witness at the hearing on this bill that increased investigation and enforcement would have a greater deterrent effect than increased penalties. I agree, and this bill was amended at markup to include a provision directing the Attorney General to give increased priority to efforts to investigate and prosecute preretail medical theft offenses.

Finally, we want to encourage the industry to exhaust all reasonable means of preventing these thefts from their properties and other facilities along the transit route.

The April 2011 edition of Fortune Magazine included an article entitled, ``Drug Theft Goes Big.'' The article reports that the thieves who committed the largest prescription drug theft in history did so by cutting through the tar roof of Eli Lilly's Connecticut warehouse and sliding down ropes. Security was so lax that the thieves were able to pull their own tractor-trailer up to the loading dock and spend a couple of hours loading the stolen goods.

In a similar event several months ago, thieves broke into a GlaxoSmithKline warehouse by coming through the roof. While none of this in any way shields or excuses the perpetrators of these crimes, clearly, these examples point to the need for more security.

Government and industry should work together at all points along the factory-to-retail chain to prevent and detect such thefts. I'm aware that industry and government regulatory authorities are working toward these ends, and I would hope that work will continue so that we will have a comprehensive effort to address this type of crime.

Madam Speaker, I yield back the balance of my time.

Madam Speaker, I rise today in support of H.R. 4223, the ``Safe Doses Act of 2012'' which amends Title 18, United States Code, to prohibit theft of medical products, and for other purposes.

More specifically, this bill will prohibit theft of pre-retail products such as drugs, medical devices and infant formula. Likewise, it forbids one from alternating labels of pre-retail medical products, transporting stolen or counterfeit medical products and purchasing or distributing expired medical products with the intent to deceive others and passing such products off as authentic.

Due to the increased activity in counterfeit drugs it is critical that Congress lay down harsher parameters so that potential criminals are faced with more deterrents should they consider participating in such behavior.

As a Representative from Houston, Texas, it is of grave concern that consumers and law enforcement officials are protected given the proximity of Texas to the Mexican border. It is not inconceivable that crime syndicates operating on both sides could cause significant problems by stealing drugs and selling them in Mexico.

The theft of large scale medical products has become a growing concern; thus, this legislation aims to toughen the penalties for individuals who place thousands of lives in danger by stealing large quantities of medical products and re-introducing such products in the legitimate supply chain including pharmacies and hospitals.

This bill is encouraged by pharmaceutical companies after instances of fraud appeared within the industry. According to an FDA affidavit, in 2009, a truck containing over 120,000 vials of insulin was stolen in North Carolina. After being improperly stored the product was illegally resold into distribution by wholesalers reaching medical centers in many other states including my state of Texas.

While some diabetic patients reported the drugs after usage and noticing poor blood sugar control, the actual amount of innocent people who received the spoiled product in pharmacies in 17 states is unknown. It was determined that the insulin was purchased from a national distribution company only one day after the medication was reported stolen. While some arrests were made in relation to this incident, over 125,000 vials of insulin were never located.

Incidents such as these are ones which this bill is intended to prevent. Serious public health and safety implications arise based on the improper care of medical products which may be both ineffective and harmful to unsuspecting patients.

Currently, Title 18 of the United States Code sets forth penalties of a fine and/or imprisonment of no more than 10 years for involvement in such crimes. While I am not quick to increase sentences, keeping one imprisoned after they have served their time, I am of the belief that consumers purchasing medicine should be able to do so with the confidence that what they are paying for is real and safe. Thus those criminals that take actions to threaten the life of another by engaging in the

transportation of counterfeit drugs should be locked up.

Despite the lack of evidence supporting the contention that offenders are less likely to engage in such deviant behavior once they are aware of federal laws increasing fines and longer penalties, I support this bipartisan measure to help ensure that our everyday Americans in need of medication are not falling prey to criminals intending to defraud them of necessary medical products.

Madam Speaker, I move to suspend the rules and pass the bill (H.R. 4223) to amend title 18, United States Code, to prohibit theft of medical products, and for other purposes, as amended.

Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous materials on H.R. 4223, as amended, currently under consideration.

Madam Speaker, I yield myself such time as I may consume.

Large-scale medical product theft is a significant problem in today's society. Medical products require special care and maintenance. When medical products are stolen, thieves resell them. When these drugs are not stored or handled properly, they can lose their effectiveness and cause further injury to medical patients.

Current law does not recognize the added importance of medical products. These products are often essential to a person's health and can be lifesaving.

Under federal law, those who steal a truck full of insulin intended for diabetics would be sentenced to the same extent as those who steal a truck full of car tires.

In 2009, an organized ring of criminals stole 129,000 vials of insulin worth approximately $11 million in North Carolina. A few months later, the FDA received a report that some of the vials had been reintroduced into the supply chain when a diabetic patient reported to a medical center in Houston, Texas, with an adverse reaction after use of insulin from the stolen lot.

The FDA issued a warning that the insulin had likely not been kept refrigerated correctly and could still be in the market. The spoiled product was ultimately found in pharmacies in 17 states. At least 2 additional patients experienced adverse reactions. While some arrests have been made, over 125,000 vials of insulin still remain unaccounted for.

Shipments of drugs that treat kidney failure, ADHD, schizophrenia, rheumatoid arthritis and ovarian cancer were stolen in three separate incidents between 2008 and 2009.

The prescription drugs, worth over $3 million, were taken during a distribution center break-in and in two separate trailer break-ins. The FBI made an arrest in only one of the three incidents, and the criminal was convicted.

H.R. 4223, the SAFE DOSES Act, modernizes and strengthens the criminal code in order to deter and punish those who steal pre-retail medical products. Enhanced penalties not only make people think twice before they steal medical shipments, but also provide law enforcement agencies with the tools they need to obtain cooperation to bring down criminal organizations.

The SAFE DOSES Act enables authorities to better target the multi- dimensional criminal enterprises that carry out these thefts and recognizes the health risks created by the improper care and handling of sensitive medical products.

This bipartisan bill helps to ensure that life-saving drugs remain in the hands of those trained to handle them, and do not continue to pose a threat to public safety. I commend Crime Subcommittee Chairman Sensenbrenner for his work on this legislation and urge my colleagues to join me in support of this bill.

Madam Speaker, I yield such time as he may consume to the gentleman from Wisconsin (Mr. Sensenbrenner), who is the chairman of the Crime Subcommittee of the Judiciary Committee and a former chairman of the Judiciary Committee, and also the sponsor of this legislation.

Madam Speaker, I yield back the balance of my time.

Madam Speakers, I rise in support of H.R. 4223, the Safe Doses Act. I am proud to join my colleagues on both sides of the aisle in supporting this important legislation.

H.R. 4223 addresses a difficult issue in the pharmaceutical supply chain: the theft of medical products. While this body last week passed important legislation to protect consumers from counterfeit drugs, there remains a real risk from stolen medical goods.

This is a not a hypothetical exercise, it is a real problem. Criminal organizations who steal medical products are not concerned with storing these materials properly, or ensuring that they are only sold with a doctor's prescription.

Let me give one brief, but telling example: In 2009, 128,000 vials of insulin were stolen in North Carolina. Beyond the $11 million monetary cost of this theft, there was a human cost as well.

These vials were reintroduced into the supply chain after being improperly stored. The vials found their way to pharmacies in 17 different states, and at least two individuals suffered potentially fatal blood sugar levels before the FDA was able to alert the public to this danger.

H.R. 4223 is a simple and sensible way to give law enforcement and prosecutors a stronger set of tools to go after criminal organizations that are brazenly stealing vital medication and devices. I further note that, beyond the bipartisan support this measure has received, the Safe Doses Act passed both the House Judiciary and Senate Judiciary Committees unanimously.

I encourage all of my colleagues to support this legislation, clean up the pharmaceutical supply chain, and protect their constituents.