House Subcommittee Expects New Hearing on Drug Safety Draft
House Energy and Commerce Committee sources have stated that they expect a new hearing to be scheduled on a discussion draft of drug safety legislation, but noted that no time has yet been set. Among other things, the draft legislation would require importer and custom broker registration for drugs, increased inspections and higher penalties. (See ITT’s Online Archives or 09/22/10 and 09/30/10 news, 10092210 and 10093003, for BP summaries of the discussion draft and the canceled September 30, 2010 hearing on it.)
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Bill in Discussion Draft Form Due to Time Constraints
Sources added that the Subcommittee on Health released the bill on September 20, 2010 in discussion draft form because there was insufficient time for it to be taken up before the mid-term elections, and they are interested in getting solid stakeholder input.
Draft is Basically the “Drug Portion” of H.R. 759
They also confirmed that the draft is basically the drug portion of H.R. 759, the Food and Drug Globalization Act, which contained provisions on food, drugs, and cosmetics. The food provisions became the basis of House-passed H.R. 2749, the “Food Safety Enhancement Act.” The sources add that they hope to take up the cosmetic portion after addressing drug safety. (See ITT’s Online Archives or 09/0910 news, 10090924, for BP summary of H.R. 5786, a bill to improve cosmetic safety, which sources could not confirm was the direction planned for cosmetics.)