Statement on the FDA Reauthorization Act
Statement on the FDA Reauthorization Act from Danielle Brian, Executive Director,
Executive Director Danielle Brian issued the following statement on the Senate’s passage today on the FDA Reauthorization Act:
"Under a false sense of urgency that FDA layoffs are imminent, 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. The threat of immediate layoffs is Chicken Little. Congress should have hit the pause button instead of fast tracking FDA user fee legislation. The legislation contains troubling provisions that loosen oversight of medical device safety and warrant scrutiny by Congress.
More broadly, Congress should rethink a system that leaves the FDA so beholden to industry not just for funding, but for the terms of that funding."
For example, one of the bill’s provisions could provide patients and regulators with less detailed and timely warnings about potentially deadly hazards associated with medical devices. People whose lives depend on the most sensitive medical devices, including those implanted in their bodies, could be left in danger as malfunctions mount.
As POGO has previously reported, the FDA receives much of its funding from so-called “user fees” paid by makers of drugs and medical devices, and the money comes with conditions. To keep the fees coming, the FDA engages in wide-ranging negotiations that give industry lobbyists extraordinary sway over how the agency does its job.
Senator Lamar Alexander, chairman of the Senate health committee, has pushed for urgent passage of the legislation, saying that Congress must send the bill to the President’s desk by the August recess or the “FDA will be forced to begin sending layoff notices to more than 5,000 employees.” The FDA Commissioner has recently said “we do not anticipate initiating the process of making a determination regarding potential RIF [Reduction in Force] notices unless and until September 30 passes without reauthorization.” And the FDA has told POGO that “In the unlikely event that FDARA [FDA Reauthorization Act] is not passed by the deadline, the FDA will be able to rely on its estimated available user fee balance at the end of FY17 of $313 million to wind down user fee program activities”—enough for “a minimum of approximately two months.”
Founded in 1981, the Project On Government Oversight (POGO) is a nonpartisan independent watchdog that champions good government reforms. POGO’s investigations into corruption, misconduct, and conflicts of interest achieve a more effective, accountable, open, and ethical federal government.