On the recordMay 30, 2012
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. {time} 1700 Whether a disease is rare or common, the need for effective care and potential cures is the same.…





