
Industry Comments on Senate Passage of PDUFA V
The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization released statements last week regarding the Senate's vote to pass the Food and Drug Administration Safety and Innovation Act, which reauthorizes PDUFA.
The Pharmaceutical Research and Manufacturers of America (PhRMA) released a statement last week regarding the Senate’s vote to pass the Food and Drug Administration Safety and Innovation Act (
Said senior vice-president Matthew Bennett in the
The Senate vote also reauthorized permanently the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), which PhRMA applauded in its statement.
These programs “have encouraged increased research into the use of medicines in children, helping us make significant advances in the care that children receive. Permanent reauthorization of these patient-focused programs will help to continue the progress made in this field by providing more certainty to the sponsors of important pediatric clinical trials,” said Bennett.
The Biotechnology Industry Organization (BIO) issued a
BIO specifically commented on the inclusion of an enhanced Accelerated Approval pathway, crafted by Senator Kay Hagan (D-NC), in the Act, which “will help expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases while preserving the FDA’s robust standards for safety and effectiveness.” The enhanced accelerated approval pathway goes beyond the current fast-track
BIO went further to say, “We greatly appreciate the Senate defeat of amendments which would have threatened final approval of FDASIA, including an amendment which would have slowed the FDA's consideration of genetically-modified salmon…. BIO also appreciates the Senate defeat of amendments pertaining to patent settlements, importation, and the elimination of innovator data protections.”
Read Washington Editor Jill Wechsler’s
NOTE: On May 30, the House passed the FDA Reform Act also reauthorizing PFUDA. See PhRMA's
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