Senate subcommittee passes FDA user fee reauthorization bill with drug price amendment

The House Energy and Commerce health subcommittee on Thursday passed the Food and Drug Administration's user fee reauthorization, reports Regulatory Focus.

If passed, the bill would reauthorize the fee system drug and devicemakers must follow for the next five years for the FDA to review their products.

The committee agreed to add four amendments to the bill, including a provision to boost generic drug competition and offer a 180-day exclusivity period for generic drugs in a limited market, according to Regulatory Focus. Other amendments involve protecting the healthcare supply chain, revamping medical device inspections and permitted over-the-counter hearing aids, which the Senate also agreed to last week.

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