Chairman Upton Kicks Off Debate on H.R. 3204, the Drug Quality and Security Act

September 28, 2013

WASHINGTON, DC – House Energy and Commerce Committee Chairman Fred Upton (R-MI) today kicked off debate on the bipartisan H.R. 3204, the Drug Quality and Security Act.

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Remarks as prepared:

Mr. Speaker, I rise today in strong support of H.R. 3204, the Drug Quality and Security Act. I am proud to say that this piece of legislation is a product of true bipartisan and bicameral work. The Senate and the House, Republicans and Democrats came together to produce a bill that will protect American patients by ensuring they receive safe drugs.

This legislation would strengthen the prescription drug supply chain in order to protect American families against counterfeit drugs. The bill also would help prevent increases in drug prices, avoid additional drug shortages, and eliminate hundreds of millions of dollars worth of duplicative government red tape on American businesses that is harming job growth.

The supply chain provisions of the Drug Quality and Security Act are the product of many years of tireless work. We know from stakeholders like Pfizer and Perrigo in Michigan that this is not just a patient safety issue; this is a jobs issue. This bill will bring certainty to the drug supply chain and ensure that patients will continue to receive the medicine they need without interruption.

H.R. 3204 also addresses drug compounding. This bill is the result of the Energy and Commerce Committee’s thorough investigation of the NECC meningitis outbreak, which began its devastating spread almost a year ago today. To date, the CDC has linked 64 deaths and 750 cases in 20 states to contaminated drugs from NECC. My home state of Michigan has been the hardest hit by the outbreak – with 19 lives needlessly lost including three in my district - and the sad truth is, it could have been prevented. This legislation is an important step in helping prevent any such tragedy from occurring again. By reviewing countless documents, holding four committee hearings and reviewing various legislative proposals, we better understood what needed to be done to help prevent a future “NECC” and built that into H.R. 3204.

H.R. 3204 upholds the current section 503A of the law and provides the clarity that FDA needs by eliminating the unconstitutional provisions. The bill also requires FDA to engage in meaningful communication with state boards of pharmacy. Further, under this bill, entities engaged in sterile drug compounding can voluntarily register with FDA and operate under FDA regulation. Finally and importantly, this bill protects traditional pharmacy compounding that occurs in community pharmacies across the country. That is why the bill has the support of the National Community Pharmacists Association, and I’d like to thank them for working with us so closely.

I’d also like to thank Chairman Pitts, Chairman Murphy, Vice-Chair Blackburn, Mr. Latta and Mr. Griffith for their outstanding leadership on these issues. I’d also like to commend Mr. Waxman, Mr. Pallone, Mr. Dingell, Ms. DeGette, Mr. Green, and Mr. Matheson for their work. I’d also like to thank Chairman Harkin and Senator Alexander for their leadership. Finally, I want to thank the Energy and Commerce staff – Clay Alspach, Paul Edattel, John Stone, and Carly McWilliams. It is because of our collaborative and tireless efforts that we are near the resolution of last year’s deadly outbreak. To all the families who have lost loved ones and to those who are still suffering today, with this bill we say “never again.”

I urge my colleagues to support this bill. I yield back the balance of my time.

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