today, the Senate passed the Food and Drug Administration Reauthorization Act of 2017, FDARA, to reauthorize user fees and other programs at the FDA to ensure that new, safe, and effective treatments get to patients in need as quickly as possible to save lives and greatly increase quality of life. While I have long preferred that Congress appropriate funding to the FDA for this purpose to avoid any conflicts of interest, I have supported user fee bills and will do so again today, as it represents a bipartisan pathway for timely drug approvals. I am pleased that this legislation increases the amount of funding that drug and device companies will contribute to the approval process. However, I am disappointed that this legislation does not address drug pricing in a comprehensive way, as I have long advocated. I will continue to work with my colleagues to press for Senate action on this critical issue. FDARA includes a number of key provisions I worked on to improve the pipeline for new pediatric drugs and devices. In particular, this legislation will reauthorize funding for critical pediatric programs such as pediatric clinical trials at the National Institutes of Health and the Pediatric Device Consortia grants under the FDA. In addition, this legislation will spur more pediatric drug development because of critical reforms to require drug companies to begin consideration of pediatric studies earlier in the drug development process.…
On the recordAugust 3, 2017
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