AIDS Healthcare Foundation (AHF) today filed a lawsuit against the Food and Drug Administration (FDA) over its denial of AHF's Freedom of Information Act (FOIA) requests regarding correspondence between the FDA and Gilead Sciences regarding its potential application to the FDA to expand the use of its AIDS drug, Truvada, for use as an HIV prevention pill for pre-exposure prophylaxis (PrEP) in uninfected individuals. The legal action was filed in the United States District Court, Central District of California. According to AHF's suit, the action is being, "…brought under the Freedom of Information Act, 5 U.S.C. Section 552, as amended, to enjoin defendants from withholding from public disclosure certain records of the United States Food and Drug Administration ("FDA")," and seeks, "To enjoin the FDA from withholding FDA records," and "To order the production of any FDA records improperly withheld from AHF."
“AHF heard from reliable sources that FDA officials were actually encouraging Gilead to apply for expanded use of its AIDS drug, Truvada, as a form of pre-exposure prophylaxis for prevention of HIV transmission”
"AHF heard from reliable sources that FDA officials were actually encouraging Gilead to apply for expanded use of its AIDS drug, Truvada, as a form of pre-exposure prophylaxis for prevention of HIV transmission," said Michael Weinstein, AIDS Healthcare Foundation President. "We were aggravated by the fact that the FDA has failed to comply with these FOIA requests and filed this legal action after repeated failed attempts to get any answers from the FDA. This action was also filed to determine the extent of collusion, if any, between Gilead and the FDA with regard to this potential use for Truvada."
Gilead's likely pursuit of FDA-approval for expanding the use of its best-selling $35 per day AIDS drug to include use as a form of HIV prevention comes following a widely-reported study released earlier this year of 2,500 high risk gay men using Truvada as prevention which showed a 44% effectiveness rate in preventing HIV transmission. AHF believes such modest results are insufficient to support FDA approval of Truvada as an HIV prevention tool—and a move that AHF and other AIDS advocates believe would set a dangerous precedent.
Background on AHF's Freedom of Information Requests
According to AHF's lawsuit, AHF filed the following FOIA requests and correspondence with FDA officials: