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Public Statements

Food and Drug Administration Reform Act of 2012

Floor Speech

By:
Date:
Location: Washington, DC

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Mr. BUTTERFIELD. I thank the gentleman for yielding, and I thank him for his leadership on our committee.

Mr. Speaker, I rise today in support of H.R. 5651, the Food and Drug Administration Reform Act, and want to simply highlight section 865, the Rare Pediatric Disease Priority Review Voucher Incentive program. I'm so pleased this section was included in the base text of the bill. I want to thank my colleagues on the committee and my good friend Congressman Mike McCaul of Texas for joining with me to see to its inclusion. Actually, we joined together in seeing to its inclusion. Also, let me give a strong thank you to Nancy Goodman with Kids vs. Cancer, who was a strong advocate on this issue.

The program will incentivize pharmaceutical companies to develop new drugs for children with rare pediatric diseases such as childhood cancers and sickle cell disease by expanding the cost-neutral priority review voucher program. Expanding the voucher program will allow pharmaceutical companies to expedite FDA review of more profitable drugs in return for developing treatments for rare pediatric disease.

Since 1980, the FDA has approved only one new drug for treatment of childhood cancer while having approved 50 new cancer-fighting drugs for adults. Children living with life-threatening conditions need access to newly developed drugs that can treat these rare diseases.

Whether a disease is rare or common, the need for effective care and potential cures is the same. Therefore, I strongly urge its inclusion in the final bill that will go to the President for his signature.

Mr. Speaker, on a slightly different note, I would also like to discuss another issue of equal importance. My colleagues and I have worked closely with the Pharmaceutical Distribution Security Alliance to craft a consensus proposal that has the support of manufacturers, distributors, wholesalers, and both the community and chain pharmacists in dealing with traceability of prescription medication.

The proposal, known as RxTEC, would establish a national standard to address the serious issue of drug traceability and pedigree. I commend PDSA for their commitment to consumer and patient safety by working so diligently with both Chambers on this very important issue, ultimately securing placeholder language in the Senate FDA reform bill.

I am very supportive of this proposal, as RxTEC increases patient access to safe medicines, improves security of the pharmaceutical distribution chain, and lowers costs and regulatory burdens. Given the seriousness of this issue, and to avoid additional injuries and potential deaths from counterfeit drugs, I urge the FDA and all parties involved in these talks to find common ground so that we can include final supply chain integrity language into the final draft similar to section 865.

I ask my colleagues on the committee to also voice their support for inclusion.

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