AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS organization, today called on Food and Drug Administration (FDA) Commissioner Margaret Hamburg to step down in response to the agency's gross mismanagement of new product reviews and a lack of transparency. Hamburg's tenure as FDA Commissioner has been marred by questionable product reviews that have ignored scientific evidence, and often FDA's own scientists. These issues have recently spilled over into the agency's questionable review of a new HIV prevention pill.
“Commissioner Hamburg was not appointed by President Obama to serve as the chief lobbyist for pharma.”
On March 22, the New York Times reported that FDA leadership previously approved a new dosage of an Alzheimer's drug "against the advice of reviewers" at the agency. Approving the new dosage allowed the drug company that makes the drug to extend the patent, but according to scientists interviewed by the NY Times, "it doesn't really have much benefit, but does substantially more harm." This controversy followed a Washington Post report that FDA "secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients."
"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," said Michael Weinstein, President of AIDS Healthcare Foundation. "Commissioner Hamburg was not appointed by President Obama to serve as the chief lobbyist for pharma."
AHF's call for Hamburg to step down is also in response to FDA's complete stonewalling of requests for information about its cozy relationship with drug companies. In a response to an AHF lawsuit on FDA's refusal to disclose documents under the Freedom Of Information Act, FDA claimed that the "premise that FDA's review of a pending drug application should be transparent is also wrong," and that "FDA's drug review process is not a participatory process." The agency also asserted that "[t]he value of public participation in FDA's scientific review of a new drug application is particularly ambiguous …"
"President Obama pledged that his administration would be the most transparent in history, yet FDA claims that it does not have to be transparent, and that the American public has no voice on how FDA conducts their business," said Tom Myers, AHF General Counsel and Chief of Public Affairs. "One can only assume that FDA's shocking lack of transparency is because Commissioner Hamburg has something to hide."
"We cannot afford to wait for the health and safety of the American public to be put at further risk before taking action. Hamburg must go," said AHF's Weinstein.
AHF believes that FDA's failure to protect the American public from unsafe and ineffective drugs has now extended into HIV. In February, FDA granted Gilead Sciences an expedited review of its application for Truvada as HIV Prevention (so-called "Pre-Exposure Prophylaxis" - or "PrEP") despite the fact that the drug failed to meet the agency's own guidelines for approving an expedited review.
"It's clearly time for a change in leadership at FDA when a drug like PrEP, which has failed several clinical trials and could potentially lead to an increase in HIV infections, is being rushed to market," said Weinstein.
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