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Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

By:
Date:
Location: Washington, DC

Mr. VAN HOLLEN. Mr. Speaker, I rise in support of S. 3187, as amended, the Food and Drug Administration Safety and Innovation Act.

I am proud to represent many of the hard working employees at the Food and Drug Administration (FDA), and this legislation provides them with the resources to fulfill FDA's mission to protect and advance public health and safety. This bipartisan legislation enables FDA to review drugs and medical devices in a timely fashion, reduces costs by authorizing a new user fee program for generic drugs, and takes important steps to prevent and mitigate critical drug shortages.

As the co-chairman of the Childhood Cancer Caucus, I am pleased that this legislation contains several provisions that will facilitate the development of safe and effective childhood cancer treatments. The legislation makes permanent two key complementary pediatric drug programs--the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Both of these programs foster the development of prescription drugs for children and the safe use of drugs by children. Finally, I am pleased that this legislation incorporates the Creating Hope Act, which I introduced with Representatives McCaul, BUTTERFIELD, and MYRICK. Under this incentive program, a pharmaceutical company that develops a drug specifically to treat a rare pediatric disease will be rewarded with a priority review voucher for another drug. I'm hopeful that this program will kick start private sector investment in new and innovative treatments for children and families affected by cancer.

I strongly urge my colleagues to support S. 3187 to provide FDA the resources it requires to guarantee the safety of American's prescription drugs and medical devices.


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