Deal reached to renew FDA user fee programs

• 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.