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The FDA

FDA may face serious reforms in 2007 under Democratic majority

Tuesday, November 21, 2006 by: Jerome Douglas
Tags: the FDA, FDA corruption, FDA reform


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(NewsTarget) Senator Edward M. Kennedy stands to criticize the Food and Drug Administration (FDA) during a Senate hearing this week for allowing what he is calling "prevailing political winds" to take a higher priority than science. "Science has, too often, had to take a back seat at the very agency which should be setting the standard for objectivity and integrity."

Democrats who wish to strengthen the FDA will get a chance when the Senate Committee on Health, Education, Labor, and Pensions session occurs, now that the Democratic Party became the majority in the U.S. Congress with November's mid-term elections.

Senator Kennedy added, "There is also growing evidence that the dedicated professionals at the FDA have been pressured to trim their scientific views to the prevailing political winds. These are symptoms of a serious illness, and we should act without delay to provide the cure."

The Senator plans to have a series of meetings held in 2007 to determine the levels of FDA oversight needed. An initial hearing entitled "Building a 21st Century FDA: Proposals to Improve Drug Safety and Innovation," is aimed to push ahead FDA reform legislation introduced by Kennedy.

An independent science-based health advisors group called the Institute of Medicine of the National Academies stated last week in initial hearings that the FDA falls short on its drug safety mission due to chronic underfunding, revolving-door leadership, and a dysfunctional culture that ignores advice from staffers about drug safety.

FDA proponents are hoping that witnesses in these hearings will reinforce the message that the agency needs more congressional funding to supplement the millions of dollars in user fees it now receives from industry. The prevailing school of thought revolves around Congress giving the FDA more authority and funding so it can restore its reputation and better protect patients from harmful drugs -- according to hearing witnesses from last Thursday's Senate hearing. ###


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