Nation’s largest AIDS group files action in United States District Court, Central District of California against the Food and Drug Administration over its denial of AHF’s Freedom in Information Act requests regarding correspondence between the FDA and Gilead Sciences regarding its potential application to expand the use of its AIDS drug, Truvada, for use as an HIV prevention pill in uninfected individuals
WASHINGTON--(BUSINESS WIRE)-- 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,” 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:
- AHF Freedom of Information Request 2/25/2011
“AHF filed with the FDA’s Freedom of Information Office on February 25, 2011 a letter requesting access to certain documents, under the Freedom of Information Act, …that show whether, from January 1, 2010 to the present, Gilead Sciences Inc. has submitted an Investigational New Drug application and/or a New Drug Application and/or a request for a new use or indication for the use of the drug Truvada (Tenofovir/Emtricitabine) as a means of ‘pre-exposure prophylaxis’ to prevent transmission of Human Immunodeficiency Virus (HIV)."
- AHF Freedom of Information Request 3/31/2011
“... Access was requested to “documents pertaining to or showing any communications or discussions, either within the FDA or between the FDA and Gilead Sciences Inc. concerning the possible indication for the use of the drug Truvada (Tenofovir/Emtricitabine) as a means of ‘pre-exposure prophylaxis’ to prevent transmission of Human Immunodeficiency Virus (HIV)."
- FDA Denial of AHF’s Freedom of Information Requests
“ By letter dated July 18, 2011, the FDA responded to AHF’s two requests and assigned case numbers 2011-2612 and 2011-1543. … The FDA denied the requests, claiming that it “cannot acknowledge receipt of such applications until they are otherwise publicly disclosed, e.g., by the applicant or when an approvable or approval letter is issued to the firm.”
- AHF Appeal
“ By letter dated August 25, 2011, AHF explained to the FDA that Gilead has made the status of any application public in a forum that included employees of the FDA and therefore the FDA’s purported basis for denying the Freedom of Information Act requests no longer exists….”
“The FDA did not respond to our appeal within the statutory time limit,” said Tom Myers, General Counsel and Chief of Public Affairs for AIDS Healthcare Foundation. “We believe pursuant to the Freedom of Information Act that AHF has the right to obtain the documents requested, and the FDA has no sound legal basis for its actions in withholding access to such documents. As a result of such ongoing avoidance and delay tactics and non-responses from the FDA, AHF decided its best course was to file this action in order to get the information requested.”
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 182,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific region and Eastern Europe. www.aidshealth.org
AIDS Healthcare Foundation
Tom Myers, General Counsel
Ged Kenslea, Communications Director
Lori Yeghiayan, Associate Director of Communications
KEYWORDS: United States North America California District of Columbia
INDUSTRY KEYWORDS: Health AIDS Biotechnology Public Policy/Government Pharmaceutical Public Policy Philanthropy FDA Foundation