Statement of Senator Hillary Rodham Clinton on Senate Passage of FDA Reauthorization
"Yesterday the Senate passed the Food and Drug Administration Reauthorization Act, legislation to implement increased safety protections and reauthorize the drug user fee program which funds many of the activities of the FDA. I am pleased that this legislation implements further mechanisms to ensure the safety of the prescription drugs for American consumers, because over the past few years I have raised concerns about the ways in which ideology, rather than science, influences the actions of this agency. With Senate passage, we are making progress toward restoring the FDA's reputation as the gold standard for unbiased consumer protection.
"These provisions will help the agency improve the availability of safe and effective treatments for our children, and include provisions from the Pediatric Research Improvement Act, which I introduced earlier this year. The Pediatric Research Improvement Act reauthorizes the pediatric rule, which gives the FDA the authority to ensure that drugs marketed to children are safe and effective for use in pediatric populations. In addition, this legislation will increase transparency into the FDA's decision making process, ensuring that pediatric drug assessments are reviewed by scientists with pediatric expertise, and improving public availability of essential information about medications for children.
"While I am pleased that we managed to make so many improvements to current law, I am deeply disappointed that this final bill maintains the sunset of the pediatric rule. We would never dream of placing a sunset on the ability of the FDA to ensure that drugs for adults are safe and effective, and we should ensure that the same protections exist for our pediatric populations. There should be no sunset on the pediatric rule, and I will continue to work with my colleagues to make this important pediatric protection permanent. In addition, I am deeply disappointed that we were not able to include legislation to allow competition in the biotech drug market. Legislation I have championed with Senators Kennedy, Enzi, and Hatch would allow the approval of safe generic versions of these expensive products which is critical to reducing drug costs for all Americans. I will continue to push for enactment of this critical proposal this year."