Congress is nearing a Sept. 30 deadline to reauthorize the Food and Drug Administration’s user fee programs, which provide funding for the review of medical devices, prescription drugs and other products over the next five years.
Right now, Congress is discussing attaching the package to a continuing resolution, which it would also need to pass before the end of the month to avoid a government shutdown. Which provisions will make it into the final bill is less clear.
“Congressional leaders have indicated that they recognize the importance of reauthorizing FDA’s user fee programs before they expire on September 30. So there is growing optimism that a 5-year legislative reauthorization will be attached to the continuing resolution,” wrote Rachel Sher, a partner at legal and consulting firm Manatt Phelps & Phillips, in an email. “Discussions are ongoing regarding which FDA-related policy riders will also be included.”
In June, the House passed a version of the bill that included provisions for clinical trial diversity and cybersecurity requirements, and had bipartisan support. The legislative package has since been held up in the Senate, where legislators have been debating sweeping riders, including one that would create a new framework for regulating diagnostic tests, bringing in vitro diagnostic tests and laboratory-developed tests into a single category.
At this point, a “clean” version of the bill without the Senate riders seems to be the most likely option, industry observers said. If that happens, it’s possible that the provisions could make it into an end-of-the-year funding bill instead.
“I think you have a bipartisan constituency on the Hill that would like to see some healthcare riders in the package,” said an industry source, speaking on anonymity.
Some of the provisions also have support from medical device groups. For example, the American Clinical Laboratory Association favored the the risk-based framework for diagnostic tests attached to the Senate bill, called the VALID Act, even though it 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. “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.”
If legislators don’t pass the user fees package on time, the FDA warned it would have to start furloughing staff. However, Congress is expected to meet the deadline.
This article has been updated with a statement from AdvaMed.