US House of Representatives Passes FDA User Fee Bill; OTC Hearing Aid Provision
On July 12, the US House of Representatives passed the FDA Reauthorization Act ( H.R. 2430) under suspension of the rules. This legislation reauthorizes the FDA’s user fee programs for prescription drug, medical device, generic drug, and biosimilar biological products. The legislation also contains a provision that would direct the FDA to develop a category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss. In early June, the House Energy and Commerce (E&C) Committee favorably reported this legislation out of committee to await consideration by the full House. The Senate Health, Education, Labor, and Pensions (HELP) Committee reviewed and approved this legislation in May.
The version of the bill passed by the House of Representatives contains additional modifications to further ensure safety and efficacy of OTC devices, including requiring the FDA to create a Web site to report on the continued quality, safety, and effectiveness of devices with respect to servicing of OTC devices.
The bill now heads to the Senate floor for consideration. The specific timing for Senate consideration is still unknown as the Senate remains focused on legislation that would repeal and replace large portions of the Affordable Care Act; however, the Senate is likely to act soon. The FDA Reauthorization Act is considered "must-pass" legislation as Congress must reauthorize the user fee agreements before the current ones expire at the end of September.