House Energy and Commerce Committee Approves FDA User Fee Bill with OTC Provision
On June 7, the House Energy and Commerce (E&C) Committee held a markup on the FDA Reauthorization Act of 2017, also referred to as the FDA user fee bill. This bill was previously approved by the House E&C Health Subcommittee and contains a provision that directs the FDA to develop a category of over-the-counter (OTC) hearing aids. During the markup, E&C Chairman Greg Walden offered a manager’s amendment that made technical corrections to the OTC provision in the legislation. These corrections included the addition of language that strengthens labeling requirements to ensure consumers understand that OTC devices are only intended for adults over the age of 18. The amended language also directs HHS to analyze and report adverse events related to OTC hearing aid devices to Congress no later than two years after the regulations are finalized. This amendment was approved.
Representative David McKinley also submitted an amendment with language that would have OTC devices include access to an assessment test performed by a licensed hearing care professional. Representative McKinley discussed his experience with hearing loss and the importance of diagnosing hearing loss before pursuing treatment options. He encouraged the House E&C Committee to continue these discussions and commit to addressing this issue even if it wasn’t through a formal amendment. The amendment was later withdrawn.
The House E&C Committee favorably reported this legislation out of the committee. The bill will now go to the full House of Representatives for final consideration. The Senate Help Committee approved similar legislation with an OTC provision on May 11.