FDA ‘reckless’ in approving Gilead’s controversial HIV ‘prevention’ pill

No HIV testing requirement baffles AIDS advocate – Press Teleconference: 3pm Eastern TODAY

In mid-February, FDA granted an expedited review of Gilead’s supplemental New Drug Application (sNDA) for use of Truvada as an HIV prevention pill—an announcement that came despite dubious research studies and days after release of another study that showed one key component of Truvada is associated with significant risk of kidney damage and disease that increases over time; FDA delayed a ruling initially due June 15th until mid-September following concerns about testing and labeling

WASHINGTON (July 16, 2012 AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider blasted the Food and Drug Administration (FDA) for its reckless decision earlier today to approve an application by Gilead Sciences for the use of its blockbuster AIDS treatment Truvada as a form of an HIV prevention pill. In February 2012, the FDA granted an expedited review of Gilead’s application for approval by the FDA to market once-daily Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV in uninfected adults.

WHAT:  
PRESS TELECONFERENCE
FDA ‘reckless’ in approving Gilead’s controversial HIV ‘prevention’ pill

WHEN:        
TODAY–Monday, July 16th – 3:00pm Eastern,  (12 noon Pacific Time)

HOW:          
Teleconference—Dial in: 1-877-411-9748    Access Code: 7134323

WHO:   
Michael Weinstein, President, AIDS Healthcare Foundation
Tom Myers, Chief of Public Affairs & General Counsel, AIDS Healthcare Foundation

CONTACTS:    
Ged Kenslea, Communications Director, AHF (323) 791-5526 mobile
Tom Myers, Chief of Public Affairs & General Counsel, AHF   (323) 860-5259 mobile

“The FDA’s approval of Gilead’s Truvada as a form of HIV prevention today without any requirement for HIV testing is completely reckless and a move that will ultimately set back years of HIV prevention efforts,” said Michael Weinstein, AHF’s President. “From the beginning we believe there was a rush to judgment by government officials and others in favor of such approval despite decidedly mixed studies offered in support. And while FDA recommends a negative HIV test prior to use of Truvada as PrEP and states that use by people with an ‘…unknown or HIV positive status…’ is ‘contraindicated,’ it in no way actually requires HIV testing in any manner—just strengthening of the ‘Boxed Warning’ on Gilead’s packaging. The FDA’s move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people.’

Gilead first filed a supplemental new drug application (sNDA) for use of Truvada as prevention in December; in February 2012, the FDA granted an expedited review of Gilead’s application for approval by the FDA to market once-daily Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV in uninfected adults.  On May 10th, the FDA held an Advisory Committee hearing on the issue during which public comment opposing such use of the drug was heard from by more than 25 members of the audience. At the conclusion of the meeting, the Advisory Committee voted to advise the FDA to grant approval of Gilead’s application. Under statutory regulations, it was expected that a ruling by the FDA would be issued by Friday, June 15th.

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