House Staffers Discuss Legislation That Aims To Improve Drug Safety

Ruzanna Harutyunyan's picture

Aides to Democratic members of the House Energy and Commerce Committee met on Monday to discuss revisions to draft legislation that aims to improve the safety of prescription drugs and medical devices, CongressDaily reports. According to CongressDaily, the proposed revisions are limited to the pharmaceutical portions of the bill and reflect provisions negotiated by FDA and the drug industry since the release of the first draft in April. None of the revisions has been finalized.


Under the revised draft, FDA would be allowed to conduct risk-based inspections of manufacturing facilities once every four years, rather than two years, although "language indicates that the maximum interval could change," CongressDaily reports. FDA officials say they need flexibility to allocate limited resources based on risk. Products from facilities that delay or prohibit inspections could be denied entry at the border. The revised bill also would require FDA to establish a system for assessing risk and determining inspection intervals within three years after the bill becomes law.

The revised draft of the bill includes an end to FDA's collection of registration fees in 2012. The amount of the registration fees FDA will charge has not been decided, CongressDaily reports. In addition, the revised draft would provide FDA with subpoena authority and could allow agency staff to develop guidelines on regulations for the agency executives' bonuses (Edney, CongressDaily, 7/29).

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