House Subcommittee Advances User Fee Reauthorizations

Posted 18 May 2017 By Zachary Brennan

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Following its Senate counterparts, the Energy & Commerce health subcommittee on Thursday advanced a bill to reauthorize the user fee agreements over the next five years for drugs, generic drugs, medical devices and biosimilars.

All four amendments were agreed to, including one to increase generic drug competition and provide 180-day exclusivity for first generics where there’s a limited market, one on protecting the supply chain, one on improving the process for medical device inspections and one on over-the-counter hearing aids.

The Senate last week also agreed to amendments on OTC hearing aids, generics and device inspections.

A number of Democrats brought up the issue of drug prices while others noted the bipartisan nature of the user fee reauthorizations.

Rep. Jan Schakowsky (D-IL) said that the user fee bill advanced in the House does nothing to lower drug prices and she called on her counterparts across the aisle to hold hearings. A drug pricing hearing has been proposed in the Senate. Rep. Frank Pallone (D-NJ) also called for "serious policy discussions on reducing drug prices."

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Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, FDA

Tags: E&C, FDA user fees, user fee reauthorization

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