AHF claims victory over FDA in HIV prevention drug case

The USA-based AIDS Healthcare Foundation (AHF) says it won a key legal victory in a push for drug safety as well as increased government transparency when a federal court ruled that the Food and Drug Administration illegally blocked Freedom of Information Act (FOIA) requests tendered by the AHF regarding correspondence between the FDA and drugmaker Gilead Sciences (Nasdaq: GILD).

The description of the documents in the court ruling also implies collusion, suggesting the FDA worked with Gilead on what to say to get the firm’s unfavorable drug trial results spun in such a way that the FDA deemed them sufficient to approve the expanded use of Truvada (emtricitabine, tenofovir disoproxil fumarate) as an HIV prevention pill for pre-exposure prophylaxis (PrEP) in uninfected individuals.

Ruling for the US District Court, Central District of California (CV 11-07925 MMM [JEMx]), Judge Margaret Morrow ordered the FDA to disclose “…complete and unredacted copies of documents…” and correspondence between the FDA and Gilead regarding the safety and efficacy of PrEP as well as the drug company’s application to the FDA for approval of the use of Truvada as PrEP.