Stop Counterfeit Drugs By Regulating and Enhancing Enforcement Now Act

Floor Speech

Mr. Speaker, I rise to voice my strong support for H.R. 5228, legislation that I authored that will strengthen FDA's ability to prevent illicit opioids from coming in through our international mail facilities by providing the agency with additional enforcement authority and financial resources.

In April, Mr. Speaker, I had the opportunity to visit an international mail facility in my home State of New Jersey with the Food and Drug Administration, Customs and Border Patrol, and the U.S. Postal Service, and to see firsthand the problems that these agencies are facing when it comes to illegal, unapproved drugs entering our country through international mail facilities.

FDA staff showed us boxes of pills that had limited labeling, labeling in foreign languages, or no labeling at all, and were sent from unknown and unregistered facilities. FDA staff explained that it takes the agency days to catalog these boxes, identify what products contained inside are legitimate, and identify what products, under current law, the agency can destroy.

FDA then had no other option but to return that box to the sender. This leaves open the possibility that the sender will just drop the box of illegal pills back in the mail and try to enter the country again through another international mail facility.

The agency also showed me a series of similarly wrapped and marked packages that contained little labeling and were misidentified as gifts. Upon inspection, these packages included bags of drugs, some labeled and some labeled in another language. Again, the agency faced the task of trying to identify if the product was a drug before it could take further action.

Now, the SCREEN Act, the bill before us, which passed the Energy and Commerce Committee by a voice vote, would give FDA authority to act in these situations to stop illicit drugs from entering the marketplace and allow the agency to better target their resources.

Specifically, the SCREEN Act would, first, expand FDA's authority to refuse or destroy illegal drugs; second, provide FDA with the ability to order manufacturers to cease distribution or to recall drugs that pose an imminent or substantial hazard to the public health. Third, it would allow FDA to refuse admission or to destroy bulk shipments of drugs from manufacturers, distributors, or importers, if they are found to be misbranded or adulterated. Then it would authorize new resources to help provide additional capacity at international mail facilities and to upgrade infrastructure, equipment, and other needed technology for screening purposes.

Mr. Speaker, having worked closely with FDA on this legislation, I know that the authorities outlined in the SCREEN Act will go a long way toward empowering the agency to take on repeated illicit drug traffickers and ensure that dangerous, unapproved drugs are stopped at our ports and at our mail facilities.

I urge my colleagues to vote in support of this bill, and I reserve the balance of my time.

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Mr. PALLONE. Mr. Speaker, I have no additional speakers. I urge my colleagues to support the bill, and I yield back the balance of my time.

Ms. JACKSON LEE. Mr. Speaker, I rise in strong support of H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, or the SCREEN Act.

Mr. Speaker, one way the nation can express its concern for our citizens' health is by addressing the issue regarding counterfeit drugs and synthetic opioids.

Among other things, H.R. 5228 will strengthen the ability of the Food and Drug Administration to combat counterfeit drugs, illegal and synthetic opioids, and opioid-like substances.

Because the capabilities of counterfeit drugs and opioids are rapidly and continuously evolving, there is no ``single'' technology that provides long-term assurance of drug security.

H.R. 5228 will implement new, holistic technology to better protect our drug supply.

Opioids are a class of drugs that include the illegal drug heroin.

All opioids are chemically related and interact with opioid receptors on nerve cells in the body and brain.

According to a recent study, Centers for Disease Control and Prevention (CDC) report there were 63,632 drug overdose deaths in 2016 in America, 42,249 of which were related to opioid overdoses.

This issue directly affects my state of Texas, because in 2016, there were 1,375 opioid-related overdose deaths, according to the National Institute on Drug Abuse.

In the city of Houston alone, there were 364 drug-related overdose deaths.

Another issue that H.R. 5228 will address is the prevalence of counterfeits, or fake medicines which are produced and sold with the intent to deceptively represent its authenticity or effectiveness.

Fake medicine may contain harmful or inactive ingredients that harm users, or might have the right active ingredient but at the wrong dosage.

Counterfeit drugs are illegal and can be harmful to your health.

Mr. Speaker, critics of the FDA say the entire screening system is underutilized and filled with incomplete and late information.

By enacting H.R. 5228, the FDA will have the authority to combat the scourge of opioids and counterfeit drugs.

I urge my colleagues to join me in supporting H.R. 5228.

Mr. GENE GREEN of Texas. Mr. Speaker, I rise in support of H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, or SCREEN Act.

I am proud to champion an important provision that was added to the SCREEN Act during the Energy and Commerce Committee's markup that clarifies the U.S. Food and Drug Administration's authority to consider the potential for misuse and abuse as part of the approval process.

In March, the Health Subcommittee received testimony from FDA Commissioner Scott Gottlieb that opioid misuse and abuse is one of the agency's highest priorities.

Last year, the FDA acted when it requested the withdrawal of the opioid pain medication Opana ER, finding, ``the benefits of the drug may no longer outweigh its risks.''

Clarifying the FDA's authority to examine the potential risks for abuse and misuse as a consideration in the approval process is an important step in combatting the opioid crisis.

I thank our committee's chairman, Greg Walden, and our Ranking Member, Frank Pallone, for supporting the inclusion of this important provision.

I ask my colleagues to join me in supporting the underlining bill, which will strengthen the FDA's authority to stop and destroy illicit substances identified through international mail facilities, and my misuse and abuse language which will help protect Americans from opioid and substance use abuse.

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