Deal reached to renew FDA user fee programs

Senate and House health committee leaders on Thursday reached an agreement to renew programs that fund key Food and Drug Administration programs for another five years.

Why it matters: Without congressional action by the end of the month, the FDA would have had to start sending out furlough notices to staff and slow down critical work like drug approvals.

• The compromise covers user fees industries pay to fund new product evaluations and is expected to be rolled into a stopgap spending bill to keep the government funded into the new fiscal year.

Details: Work on the must-pass bill hit a hit a snag in July, when Sen. Richard Burr (R-N.C.) insisted on stripping policy riders that would have increased FDA oversight of dietary supplements, cosmetics, infant formula and lab-developed tests. The policy provisions also would have tweaked a fast-track drug approval process.

• Thursday's agreement between Democratic and Republican leaders on the Senate Health, Education, Labor and Pensions and House Energy and Commerce committees tracks largely with Burr's wishes for a "clean" bill, lawmakers said.
• Burr told reporters that the compromise was "about as close to clean as you can get."
• However, the bill could still attract narrower policy changes. Senate Republican Leader Mitch McConnell has also insisted on a clean reauthorization without extraneous items, as Politico first reported.

• An aide for Senate HELP Chair Patty Murray (D-Wash.) said the deal "won't force FDA to send out pink slips along with some additional policies," but that Murray would continue to insist on reforms.

What's next: The user fee bill will be added to the stopgap spending bill that Congress could vote on next week and would fund the government into December.

The big picture: Possible changes to the FDA's oversight of cosmetics, supplements, lab-developed tests and infant formula might have to wait until the next Congress.