Trump signs FDA user fee reauthorization into law
- President Trump on Friday quietly signed into law the Food and Drug Administration Reauthorization Act of 2017, extending the user fee agreements with industry that help fund the regulator's operations for another five years.
- Trump's signature had been expected following Senate passage of the bill by a vote of 94-1, even though both legislative chambers had effectively ignored the White House's demands to make the FDA 100% funded through user frees, rather than its current mixture of fees and government funding.
- Still, the administration's subdued handling of a major piece of health legislation passed on a bipartisan basis raised some eyebrows.
The legislation, commonly referred to by its acronym FDARA, allows the regulator to collect fees through 2022 to support review of prescription drugs and medical devices, as well as of generics and biosimilars.
"By signing the FDA Reauthorization Act of 2017 into law, President Trump is ensuring that safe and effective, life-saving treatments will continue to reach American patients, from innovative new drugs, to generic drugs, biosimilars, and medical devices," Health and Human Services Secretary Tom Price said in a brief August 18 statement.
Industry negotiated the bill with lawmakers in both the House and Senate and supported the version which eventually passed both chambers and became law. Both PhRMA and BIO, the largest trade lobbies for the pharmaceutical and biotech industries, were effusive in praising the legislation.
Existing user fee agreements were set to expire on September 30, which would have triggered layoffs of FDA staff.
"By reauthorizing PDUFA and the other user fees, the administration is leading the way toward greater efficiency at the U.S. Food and Drug Administration (FDA) and increasing competition in the biopharmaceutical market," PhRMA CEO Stephen J. Ubl said in a statement.
Vermont Senator Bernie Sanders was the only senator to vote no on passing the legislation, opposing the legislation because it does "nothing to lower drug prices and is a giveaway to the pharmaceutical industry," according to comments from spokesman Josh Miller-Lewis cited by AP.
Reauthorization of industry user fee agreements had been seen as an opportunity to potentially take up consideration of drug pricing. The Senate, however, passed the bill without any major amendments or policy riders, possibly signaling that major pricing legislation is off the near-term agenda.
The Project on Government Oversight, an independent non-profit U.S. organization, has raised concerns about the close relationship between the FDA and industry.
"Congress is rubber stamping a deal that the FDA negotiated with the very industry it oversees — a deal that the FDA negotiated with a budgetary gun to its head," said POGO executive director Danielle Brian following Senate passage. "Congress should have hit the pause button instead of fast tracking FDA user fee legislation."
One of POGO's chief concerns is that the bill means patients and regulators could receive less detailed and timely warnings about issues with medical devices.
- Health and Human Services Press release
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