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Drug Quality and Security Act

Floor Speech

Location: Washington, DC


Mr. PITTS. Mr. Speaker, I am very pleased that the House is considering today H.R. 3204, the Drug Quality and Security Act. This legislation would address two important issues affecting the quality and security of America's drug supply.

First, the bill would protect traditional pharmacies and clarify laws related to human drug compounding in response to last year's nationwide meningitis outbreak--one of the largest public health crises in recent memory.

Second, the bill would strengthen the prescription drug supply chain in order to protect American families against counterfeit drugs.

As we all remember, in the summer and fall of 2012, a Massachusetts company, the New England Compounding Center, the NECC, shipped over 17,000 vials of an injectable steroid solution from three contaminated lots to health care facilities across the country. After receiving injections of NECC's contaminated steroid, over 64 people died from complications associated with fungal meningitis, and 750 others were stricken with meningitis or other persistent fungal infections.

Title I of H.R. 3204 is based off of Representative Morgan Griffith's Compounding Clarity Act and is the culmination of a nearly yearlong House Energy and Commerce Committee investigation. It clarifies FDA's authority over the practice of compounding drugs, and it requires FDA to engage in dialogue with State regulators to prevent against another tragedy like NECC's while protecting the role of traditional pharmacies in compounding.

Title II, based on Representative Bob Latta's Safeguarding America's Pharmaceuticals Act, addresses the safety of the Nation's prescription drug supply chain, as drugs travel from the manufacturer to the pharmacy. It creates a uniform national standard for drug supply chain security to protect Americans against counterfeit drugs while eliminating needless levels of bureaucracy.

The Drug Quality and Security Act is the result of months of bipartisan, bicameral negotiation, and I would like to thank Chairman Upton, Ranking Member Waxman, Chairman Emeritus Dingell, Representatives Griffith, Latta, Pallone, DeGette, and Gene Green for their work on this important legislation, and also Senators Harkin and Alexander in the Senate.

Finally, I would like to thank the staff of the Energy and Commerce Health Subcommittee, especially Clay Alspach, Paul Edattel, Carly McWilliams, Heidi Stirrup, and Monica Volante.

This bill is supported by PhRMA, the Generic Pharmaceutical Association, the National Community Pharmacists Association, the Healthcare Supply Chain Association, and the Pharmaceutical Distribution Security Alliance, among others.

I would urge all of my colleagues to support this commonsense, bipartisan legislation.


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