The Wall Street Journal reports this morning that AIDS Healthcare Foundation (AHF) won a key legal victory today in the push for drug safety, as well as increased government transparency, when a federal court ruled in their favor in a battle over approval of the HIV treatment drug Truvada as a prophylaxis.
Their suit claims that the Food and Drug Administration (FDA) illegally blocked Freedom of Information Act (FOIA) requests tendered by AHF regarding correspondence between the FDA and Gilead Sciences, maker of Truvada.
The judge’s description of the documents in the court ruling also implies collusion, said the news report, suggesting the FDA worked with Gilead on what to say to get their unfavorable drug trial results spun in such a way that the FDA deemed them sufficient to approve the drug for expanded use of Truvada as an HIV prevention pill for pre-exposure prophylaxis (PrEP) in uninfected individuals.
Additionally, the court’s ruling implies collusion, suggesting the FDA cooperated with Gilead on what to say to get their unfavorable drug trial results spun in such a way that the FDA deemed them sufficient to approve the drug.
Ruling for the United States District Court, Central District of California (CV 11-07925 MMM [JEMx]), Judge Margaret M. Morrow ordered the FDA to disclose “…complete and un-redacted 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.