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Obama Presidency Sparks Hope for a New, Improved FDA

Nov 6, 2008 | Parker Waichman LLP With a Barack Obama presidency just months away, both industry representatives and consumer groups are lobbying for strong new leadership at the Food & Drug Administration  (FDA).  Both groups believe that such leadership could restore confidence in the much-maligned agency, which has been seen as weak,  incompetent and too-political during the last eight years.

That the FDA was neglected during the Bush Administration is an understatement.  For more than half of the last 8 years, the agency lacked a permanent commissioner.  Critics of current Commissioner Andrew von Eschenbach complain that he has maintained a largely hands-off policy. Meanwhile, scandals involving drugs like Vioxx and heparin, dangerous side effects from other medicines, plus recalls of peanut butter, spinach and other foods, hurt the FDA's reputation.

Under the Bush administration, the FDA was also accused of allowing politics to interfere with science, particularly when it initially rejected over-the-counter sales of the Plan B emergency contraceptive.

Consumer advocates want to see an FDA with more funding and more clout.  According to Reuters, many are advocating a medical doctor or someone with a science background who can play a more active role in decision-making.  Strangely enough, many from the industries the FDA regulates agree.

"Due to the vital nature of the FDA's public health oversight, identifying a strong, independent FDA commissioner should be among the first accomplishments of the new administration," Billy Tauzin, head of the Pharmaceutical Research and Manufacturers of America, said in a statement to Reuters.

"It's absolutely important that patients have confidence in the medicines they take," Ian Spatz, vice president of global health policy for Merck, told Reuters.  He said the FDA needs a leader "with not only the trust of the president but also the trust of key members of Congress".

Others would like to see the Obama Administration go further, and make the FDA an independent agency.  Right now, the FDA falls under the oversight of the Department of Health and Human Services.  More independence, coupled with a renewed focus on science on the part of FDA leadership, could insulate the agency from the kind of politics that plagued the Plan B decision.

"It's been extraordinarily difficult for the agency over the past eight years," Susan Wood, former head of the FDA's Office of Women's Health, told Reuters.  "The scientific decisions ... of the approvals and any regulations that are issued need to be valued and used appropriately, and I think the commissioner plays an important role in ensuring that happens."

Woods, who resigned over the Plan B decision, has been mentioned by consumer advocates as a candidate for FDA commissioner.

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