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Posted 28 March 2012 | By Alexander Gaffney, RAC
The AIDS Healthcare Foundation (AHF) has launched an aggressive public advocacy campaign calling for the resignation of the US Food and Drug Administration's top regulator, Commissioner Margaret Hamburg in response to FDA's approval of the anti-HIV prophylaxis drug Tuvada.
In a statement released to the media on 27 March, AHF called on Hamburg to step down "in response to the agency's gross mismanagement of new product reviews and a lack of transparency" at FDA.
"Hamburg's tenure as FDA Commissioner has been marred by questionable product reviews that have ignored scientific evidence, and often FDA's own scientists," continued AHF. "Under the leadership of Commissioner Hamburg, the FDA has proven that it cannot be trusted with protecting the American public from unsafe and ineffective drugs."
AHF said it was particularly upset about FDA's expedited review of Gilead Sciences' Truvada, which was approved in February 2011 as a Pre-Exposure Prophylaxis (PrEP) product used to help prevent HIV.
AHF claims the drug "failed to meet the agency's own guidelines for approving an expedited review," and that the drug is unsafe for use.
The campaign follows an earlier attempt by AHF to draw attention to FDA through an ad campaign entitled, "What's Rotten at FDA?"
The ads similarly targeted FDA, asking the public to contact US Department of Health and Human Services Secretary Kathleen Sebelius to press FDA on the Truvada approval.
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Tags: Resignation, AHF, AIDS, PrEP, HIV, Latest News, Hamburg, approval, NDA
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