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.
The case proves for critics of the FDA what they have asserted for years – that the agency is beholden to drug makers and not to safety laws. AHF president Michael Wienstein said,
“This ruling confirms one of our deepest suspicions: the FDA colluded with Gilead to fast-track approval of Truvada as PrEP regardless of the results of clinical trials. Judge Morrow’s ruling suggests the FDA advised Gilead how to conceal unfavorable clinical trial results and coached them on what to say to get those unfavorable results spun in such a way that the FDA deemed them sufficient to approve the drug.
“All the while,” he said, “the FDA was illegally denying our FOIA requests on this issue. Today’s ruling is a huge victory for increased government transparency, and one which will hamper the government’s ability to withhold information about a drug’s safety and efficacy.”
The WSJ reports that “By September 2011, AHF was fed up enough to file a lawsuit against the FDA over its denial of several AHF Freedom of Information Act requests regarding correspondence between the FDA and Gilead Sciences regarding Truvada’s potential application.
Using Truvada as a preventative is controversial for many reasons, not the least of which is giving men a reason to :let their guard down,” contracting other STD’s.
The FDA approved Gilead’s application for use of Truvada as PrEP on July 16, 2012, despite repeated expressions of concern and complaints from AHF and other advocates.”
Tom Myers, General Counsel and Chief of Public Affairs, said this. “While the FDA is supposed to act as a neutral entity, the court ruling today confirms the FDA had private discussions with Gilead, and even fought on Gilead’s behalf to withhold documents submitted to them by Gilead.
“The lack of neutrality shown by the FDA here is breathtaking–further underscored in recent years by the fact that the FDA’s budget for drug approval is now directly paid for by pharmaceutical companies such as Gilead.”
Judge Morrow’s ruling suggests that the FDA worked together with Gilead to conceal unfavorable clinical trial results and used the very narrow FOIA privileges to conceal negative information. Citing a declaration of David J. Pizzuti, Gilead’s Vice President of Regulatory Affairs, the Court noted:
“Pizzuti also reports that Gilead and the FDA discussed what datasets Gilead would submit in support of the Truvada for PrEP applications. In addition, he states, Gilead had discussions with the FDA regarding other studies conducted with Truvada that contained unfavorable results.
Gilead and the FDA discussed how the safety and efficacy data proffered with Gilead’s supplemental NDA was nonetheless sufficient to support approval.
Pizzuti reports that these discussions were memorialized in correspondence withheld by the FDA under Exemption 4, and that disclosing the discussions would reveal how challenging PrEP study results can be successfully addressed, enabling competitors to craft successful PrEP applications that will cause Gilead competitive harm in the PrEP market.”