FDA user fee package to be included in bill to fund government, avoid shutdown, senators say

Legislation to re-authorize the Food and Drug Administration’s user fee programs for the next five years will be included in a continuing resolution to avoid a government shutdown, Senate leaders of a key committee confirmed on Thursday.

“Senator [Patty] Murray has reached a deal on a practically clean reauthorization that ensures Congressional inaction won’t force FDA to send out pink slips along with some additional policies,” an aide to the Washington Democrat wrote in an emailed statement to MedTech Dive, adding that the lawmaker would continue pushing for reforms after the immediate challenge is addressed.

On Thursday, Senate Committee on Health, Education, Labor and Pensions ranking member Sen. Richard Burr, a Republican representing North Carolina, told reporters that a “practically clean” version of the bill would be included in the continuing resolution, Politico reported.

If lawmakers decide to go with a “clean” user fee bill without additional amendments, known as riders, the amendments could be included in a funding bill that Congress is expected to pass by the end of the year.

The FDA user fee programs provide much of the funding for the agency’s review of prescription drugs, medical devices and other products. Without an extension of the user fees, the FDA has warned it would have to start furloughing staff.

Lawmakers, lobbyists and advocates are still battling over what to include in the bill beyond continuing to levy user fees to fund the review programs. That includes product listing standards for dietary supplements, and regulation for lab-developed diagnostic tests, which have been favored by consumer advocacy groups including the Pew Charitable Trusts. FDA oversight of cosmetics has also been discussed by the Senate. Industry advocates differ with consumer groups over the details of diagnostic regulation.

In June, the House passed a version of the user fee bill that included bipartisan provisions requiring clinical trials be more diverse, and that device makers improve cybersecurity protection.

The American Clinical Laboratory Association has said it favors the risk-based framework for diagnostic tests attached to the Senate bill, called the VALID Act, although it has proposed some changes.

“We continue to believe that a blended version of the House and Senate bills that includes the VALID Act can and should get done as soon as possible,” AdvaMed CEO Scott Whitaker said in an emailed statement before the Thursday announcement. “There is clearly broad bipartisan support for this type of legislative package, and it will set the agency on the right path for future innovation.”

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