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Public Statements

Counterfeit Drug Penalty Enhancement Act of 2012

Floor Speech

Location: Washington, DC


Mr. SMITH of Texas. Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I thank Mr. Meehan of Pennsylvania and Ms. Linda Sánchez of California for their work on this issue. This is a bipartisan, bicameral bill. Similar legislation sponsored by Senator Leahy was approved by the Senate last March by voice vote.

This bill enacts penalties for trafficking in counterfeit drugs similar to those for trafficking in military goods and services, as established in the National Defense Authorization Act, which Congress passed last December.

Counterfeit military goods affect the credibility of the supply chains that support our national defense, and counterfeit drugs call into doubt the credibility of America's pharmaceutical legal drug supply. In both situations, the significant and multiple dangers to the public demand enhanced penalties.

Counterfeit drugs are fake drugs. They may be contaminated, contain the wrong ingredient or no ingredient at all, or have the right active ingredient but the wrong dose. They are intentionally packaged to convince the consumer they are genuine. Counterfeit drugs are illegal and can be harmful to a person's health and even deadly.

Counterfeit drugs present not only a financial loss to the manufacturer or mark holder, but also a real health risk to consumers.

While current law technically includes counterfeit drugs, the law does not expressly prohibit trafficking in counterfeit drugs and carries a maximum penalty of only 10 years.

Late last month, the U.S. Food and Drug Administration warned consumers and health care professionals about a counterfeit version of Adderall that is available for sale on the Internet. Approved for treatment of attention deficit hyperactivity disorders, this medication is a prescription drug classified as a controlled substance, a class of drugs for which special controls are required for dispensing by pharmacists. The FDA's preliminary laboratory test revealed that the counterfeit version of this drug contained the wrong active ingredients. The counterfeit product contained none of the four active ingredients found in the genuine medication. In fact, it contained two different drugs found in medicines used to treat acute pain.

Rogue Web sites and corrupt distributors now prey on the fears of Americans when medicines are in short supply. Drug shortages have increased in frequency and severity in recent years and adversely affect patient care. An unfortunate and potentially deadly side effect of drug shortages is counterfeit drug trafficking.

Last February, the FDA warned health care professionals and patients about a counterfeit version of Avastin, a cancer treatment. Tests revealed the counterfeit version did not contain the medicine's active ingredient. This may have resulted in patients not receiving needed cancer therapy. Several medical practices in the United States may have purchased the counterfeit drug from a foreign supplier. The FDA requested that the medical practices stop the use of any remaining products from this supplier. Unfortunately, in this case alone, there were dozens of cancer patients who may never know that they did not receive lifesaving cancer drugs. Instead, they got a useless counterfeit drug, a drug counterfeited and sold only for the purpose of financial gain. These recent situations prove that those who traffic in counterfeit drugs should be subject to enhanced penalties.

I urge my colleagues to support this bicameral legislation, and I reserve the balance of my time.


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