AHF claims victory over FDA on Gilead’s PrEP

The USA-based AIDS Healthcare Foundation(AHF) says it has won another key legal victory late last week in a push for drug safety as well as increased government transparency.

The AHF said that a federal court ruled against the Food and Drug Administration and rejected the overwhelming majority of exemptions sought by the FDA in Freedom of Information Act (FOIA) requests tendered by the AHF regarding correspondence between the FDA and Gilead Sciences (Nasdaq: GILD) related to Gilead’s New Drug Application for use of its blockbuster AIDS drug, Truvada (tenofovir disoproxil fumarate and emtricitabine), for pre-exposure prophylaxis (PrEP) as a form HIV prevention.

In a ruling late last week, the US District Court, Central District of California issued a Judgment and Order that requires the FDA to provide AHF with data, documents, correspondence and meeting minutes between the agency and Gilead. Last August, AHF won an initial ruling in its FOIA case against the FDA; however, the FDA claimed exemptions for many documents. At the time, the court directed the FDA to file a Vaughn Index (a document that agencies prepare in FOIA litigation to justify each withholding of information under a FOIA exemption), and ordered the FDA to provide certain documents ‘in camera’ for inspection by the court.