AHF calls for top to bottom shake-up of management at FDA

AIDS Healthcare Foundation (AHF)Feb 3 2012

AIDS Healthcare Foundation (AHF) today called for a top to bottom shake-up of the management at the Food and Drug Administration (FDA) as well as a Congressional investigation following the publication of a Washington Post news article (1/31/12) that reported, "…the Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients." Last week, a group of six of the current and/or now former FDA scientists sued the agency by filing whistleblower complaints over the agency's illegal surveillance of their personal email accounts. The group asserts they have a legal right to air their concerns to Congress or journalists regarding the safety and efficacy of devices for cancer screening and other purposes that they reviewed.

“…the Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients.”

Last September, AHF had separately sued the FDA over its denial of the AIDS group's Freedom of Information Act requests regarding any correspondence between the FDA and Gilead Sciences regarding the drug company's potential application to expand the use of its blockbuster AIDS treatment, Truvada, for use as an HIV prevention pill in uninfected individuals. AHF officials had been told by sources that Gilead was being encouraged by government officials to apply for the expanded use of the drug as an HIV prevention tool—despite the fact that one widely-reported research study cited in support of such expanded use showed a modest 44% effectiveness rate in preventing HIV transmission.

"The inappropriate and illegal surveillance of FDA employees' personal email accounts by FDA brass demands a top to bottom shake up of management at the FDA as well as a full Congressional investigation into the matter," said Michael Weinstein, AIDS Healthcare Foundation President. "The mission of the FDA is to protect the public health by ensuring that our food, drugs and medical equipment and devices are safe and do not cause harm to the public. In our own situation, AHF heard from reliable sources that FDA officials were encouraging Gilead to apply for expanded use of its AIDS drug, Truvada, as a form of pre-exposure prophylaxis for prevention of HIV transmission despite significant questions about its potential effectiveness at that. We were concerned that the FDA failed to comply with our FOIA requests and as a result, we filed a legal action late last September after repeated failed attempts to get any answers from the FDA. Through that action, we also hoped to determine the extent of collusion, if any, between Gilead and the FDA with regard to this potential expanded 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—commonly known as pre-exposure prophylaxis (PrEP) for uninfected individuals—comes following a widely-reported study released earlier last 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.

AHF's legal action was filed in the United States District Court, Central District of California, seeking to "…enjoin the FDA from withholding FDA records," and "To order the production of any FDA records improperly withheld from AHF."

Background on AHF's Freedom of Information Requests

According to AHF's September 2011 lawsuit, AHF filed the following FOIA requests and correspondence with the FDA:

• 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…."

"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," said Tom Myers, General Counsel and Chief of Public Affairs for AIDS Healthcare Foundation. "As a result of such ongoing avoidance and delay tactics and non-responses from the FDA, AHF decided its best course was to file the legal action in order to get the information we requested."

Separately, a recent New York Times article (Sunday January 29, 2012) reported on a pattern of various U.S. government agencies' responses—or lack thereof—to outstanding FOIA requests. The article posed the question: "Is a FOIA delayed a FOIA denied?" reporting that, "On Jan. 4, (2012) The New York Times received a final response from the Defense Department to a FOIA request made on June 1, 1997," wryly noting, "The department sent it by Federal Express, Priority Overnight."