Congress moves forward with "clean" deal to fund FDA
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A deal to renew funding for Food and Drug Administration drug and device evaluations will move forward this week, but without additional reforms to increase oversight of dietary supplements, lab-developed tests and other areas, congressional aides said Monday.
Why it matters: The "clean" extension of FDA user fees for five years means the agency will avoid having to send out furlough notices to its staff. But it indefinitely forfeits the chance to expand the FDA's regulatory purview.
Between the lines: The deal, first reported by STAT, follows the wishes of top Republicans like Senate Minority Leader Mitch McConnell (R-Ky.) and Senate HELP Committee Ranking Member Richard Burr (R-N.C.), who had pushed for the "clean" extension ahead of a Sept. 30 deadline. It will be passed with a stopgap spending bill to keep the government running.
- Still, Democrats set up the prospect for a year-end showdown, renewing smaller FDA programs only through Dec. 16, meaning agency issues would have to be revisited in an end-of-year funding package.
- Bigger policy changes could include increased oversight of supplements and cosmetics, as well as reforms to a fast-track drug approval process that has come under scrutiny after the approval of a controversial Alzheimer's drug.
The bottom line: At least for now, funding for the FDA's work is continuing without efforts to increase oversight.
- "It's difficult not to note that the effect of reauthorizing only the fees is to move forward those parts of the bill negotiated privately with industry ... and to sideline reforms that mostly would increase oversight and could benefit patients," tweeted Rachel Sachs, a health law expert at Washington University in St. Louis.
