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from www.medreps.com – The nation’s largest HIV/AIDS organization is calling on the head of the Food and Drug Administration (FDA) to step down, saying the agency’s mismanagement of its pharmaceutical sales approval process of new products is putting the public at risk.
Members of the AIDS Healthcare Foundation (AHF) said they want Commissioner Margaret Hamburg to resign in light of its questionable review of a new HIV prevention treatment and reports that the FDA secretly monitored the personal email of a group of its own scientists and doctors after it warned Congress that the agency may be approving unsafe products, as reported by the New York Times.
The FDA recently granted Gilead Sciences an accelerated review of its application for the HIV prevention drug PrEP, even after the agency voiced concerns that the treatment failed to meet certain federal guidelines.
“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,” Michael Weinstein, AHF president, stressed.
Meanwhile, the FDA email monitoring scandal has led two Republican Congressmen to call on the Obama administration to assess current guidelines for monitoring federal worker’s personal internet accounts.