U.S. Rep. Tom Emmer (R-Minn.) has introduced a bill that would allow FDA to continue processing new medical device applications and associated user fees in the event of another partial government shutdown.
Medical device companies pay fees to FDA when they register their businesses and list their devices with the agency, whenever they submit an application or a notification to market a new medical device in the U.S., and for certain other types of submissions. These actions fall under the Medical Device User Fee Amendments (MDUFA).
FDA staff continued performing work funded by user fees collected before the 35-day shutdown that ended Jan. 25, but did not accept any device applications or new fees during the lapse. About 50% of device reviews are paid for by user fees, according to Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, an organization of patient groups, consumer advocates, biomedical research advocates, health professionals and industry representatives.
Emmer’s bill, the Medical Innovation Never Stops Act, would allow the FDA to continue processing new device applications and associated user fees during a lapse in appropriations.
“This common-sense fix will allow the FDA to access funds that companies have already agreed to pay for the review process,” Emmer said in a prepared statement. “Patients deserve access to life-saving devices, and companies dedicated to providing these innovations should not have their hands tied by the government’s inability to provide adequate funding for its agencies.”
Medtech trade group AdvaMed praised Emmer’s bill. “The provisions in this legislation, if adopted, would help ensure the pipeline of innovative new diagnostics, treatments, and cures will not be delayed, ultimately to the benefit of patients,” said AdvaMed president & CEO Scott Whitaker in a separate statement. “The bill would also help alleviate potentially crippling delays in manufacturer planning and operations, which can be particularly acute for resource-constrained start-ups and small companies.”
FDA had collected $7.5 million in medtech user fees at the end of fiscal year 2017, Whitaker noted. “We look forward to working with members of the House and Senate to move forward with this legislation,” he said.
