Drugs

Gilead Promoting Truvada Off-label Use: AIDS Group

The AIDS Healthcare Foundation (AHF) is asking FDA to take enforcement action against Gilead Sciences for off-label promotion of its Truvada (emtricitabine and tenofovir disoproxil fumarate) for situational pre-exposure prophylaxis (PrEP) to prevent HIV infection. A recent letter to FDA acting commissioner Stephen Ostroff is the latest AHF action seeking to hold Gilead accountable for the off-label promotion.

“In contravention of statute and regulations,” the letter says, “Gilead appears to be promoting situational use of its AIDS treatment Truvada for PrEP, misleading viewers into believing that Truvada is safe and effective for use on a situational basis, despite knowing that the drug is not FDA approved for such use.”

The letter follows publication of a news article on Australia’s Gay News Network focusing on a video that appears to promote situational rather than daily use of Truvada “for men who enjoy recreational sex and drug use but do not test regularly for HIV.” The article said that the campaign “is supported by Gilead Sciences, manufacturer of Truvada.” The TV ad entitled “I Like to Party” also has a slate at the end reading “Supported by funding from Gilead Sciences” and also crediting Public Health Solutions, a New York City-based non-profit, and Connected Health Solutions, described as a Brooklyn-based organizational development consultancy.

“Gilead, which we believe has been deliberately mounting an under-the-FDA-radar, guerilla-style marketing and media campaign for PrEP for the past three years by funding scores of community and AIDS groups across the nation to promote PrEP, has run afoul of FDA by funding this as promoting off-label use of PrEP,” says AHF president Michael Weinstein.

The group asks the agency to take immediate action to: (1) require Gilead to cease and desist all such off-label promotion; (2) require Gilead to publically correct the misinformation disseminated by the ad campaign; and (3) impose any sanctions permitted by law. The letter also was sent to the HHS Inspector General.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome