Industry Comments on Senate Passage of PDUFA V

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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 (FDASIA), which reauthorizes the Prescription Drug User Fee Act (PDUFA). PDUFA was created by Congress in 1992 and must be reauthorized every five years. The current program, known as PDUFA IV, will expire unless reauthorized by Congress on Sept. 30, 2012 (see back story, and FDA’s take).

Said senior vice-president Matthew Bennett in the statement, “By reauthorizing PDUFA, members of both sides of the aisle have taken an important step forward toward providing the FDA with much-needed resources and management tools to support patient safety and to promote innovation through increased consistency and efficiency in FDA’s science-based human drug review program.”

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 statement in support of the Senate votes as well. “In particular, we appreciate the leadership shown by Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) to craft a bipartisan measure which will continue to ensure patient safety, access to the newest cures and therapies, and job growth in America,” said the BIO statement.


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 process, to “enhance the authority of the FDA to consider appropriate scientific data, methods, and tools, and to expedite development and access to novel treatments for patients with a broad range of serious or life-threatening diseases or conditions,” says the Senate-passed legislation (S. 3187). Updated guidance would be required.

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 blog on the Senate votes and what is needed next.

NOTE: On May 30, the House passed the FDA Reform Act also reauthorizing PFUDA. See PhRMA's statement.