Health Chair Enzi Envisions Timely Crawford Confirmation
This article was originally published in The Tan Sheet
Executive Summary
Senate Health Committee Chairman Michael Enzi (R-Wyo.) expects a vote on Acting FDA Commissioner Lester Crawford's nomination to the permanent post to proceed as scheduled on April 13
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Senate Health Committee Chairman Michael Enzi (R-Wyo.) expects a vote on Acting FDA Commissioner Lester Crawford's nomination to the permanent post to proceed as scheduled on April 13. Senate Health Democrats Hillary Clinton (N.Y.) and Patty Murray (Wash.) say they will place a hold on the nomination. However, Enzi told attendees at the Food & Drug Law Institute annual conference in Washington, D.C. April 7 that the vote is going forward as planned. The two Democrats said they will delay the nomination following an "unsatisfactory" meeting April 6 with Crawford regarding the agency's handling of the Rx-to-OTC switch of Barr Labs' Plan B emergency contraceptive. While the committee members wrangle over the timing of Crawford's status, issues of drug safety and the agency's organizational structure continues to come under debate. Senate leaders from both sides of the aisle, including Finance Committee Chairman Chuck Grassley (R-Iowa), have taken the stance that an independent drug safety board would address concerns of a conflict of interest within FDA between drug safety and drug approval procedures (1 (Also see "Sen. Grassley’s Proposed Drug Safety Office Would Have Labeling Authority" - Pink Sheet, 14 Mar, 2005.), p. 7). Enzi is opposed to the proposal: "There is a push to have a separate safety board or a person that can separate that safety issue out, and I'm fighting that," he said. The Health Chair cited the potential for an independent safety group to overreact to lesser adverse events typically listed in direct-to-consumer advertisements. "If I'm the guy in charge of safety, and I see those ads, I've got to say, that's not safe. I don't care if it's just diarrhea. I know people can die from diarrhea," Enzi said. "So if I'm the safety guy and that is my job, I pull every drug that has a problem with diarrhea." Enzi touched on a number of points during his speech, including his position on drug reimportation. "There is momentum at the moment to do something on importation....We're beyond whether to do it or not: it will be done. There will be a bill for importing drugs." "Right now there are more than 60 people who are ready to vote for that in the Senate," making a bill immune to filibuster. |