User fee package goes to Senate with lab-developed test, OTC hearing aid provisions – MedTech Dive

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Dive Brief:

• The Senate Committee on Health, Education, Labor and Pensions voted Tuesday to send a bill to the Senate that would reauthorize the Food and Drug Administration to collect user fees from device- and drug-makers for the next five years. 
• A provision would require the FDA to finalize guidance that would create a category of over-the-counter hearing aids within a month of the bill’s passage. The FDA last issued a proposed guidance in October.
• Committee Ranking Member Sen. Richard Burr, R-N.C., questioned on Tuesday whether the FDA should have that expanded authority, despite co-sponsoring legislation that would change how diagnostic tests are regulated, including laboratory-developed tests.

Dive Insight:

The Senate version of the user fee bill passed the committee late Tuesday by a 13-9 vote. 

The hearing aids provision was added to a draft of the bill in late May, as the FDA has delayed finalizing a rule establishing over-the-counter hearing aids. Congress passed legislation in 2017 that would allow adults to purchase them without an exam or fitting by an audiologist.

“I am incredibly frustrated it is taking FDA so long to take a step that will lower costs for millions of people across the country,” said Senate HELP Committee Chair Patty Murray, D-Wash.

Meanwhile, Burr stepped back on legislation he cosponsored that would clarify the FDA’s authority to regulate lab-developed tests, questioning whether the agency could be trusted with new responsibilities after its response to the infant formula shortage. 

“We still have a long way to go on this bill before it becomes law. And I’ll be watching the actions …….

Source: https://www.medtechdive.com/news/FDA-user-fee-bill-senate-HELP-markup/625517/