Ruling by the U.S. District Court, Central District of California requires the Food and Drug Administration to disclose "…complete and unredacted copies of documents withheld…" related to the safety and efficacy Gilead's AIDS drug, Truvada, for use as an HIV prevention pill for pre-exposure prophylaxis (PrEP)
The description of the documents in the court ruling implies collusion, 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
WASHINGTON--(BUSINESS WIRE)--AIDS Healthcare Foundation (AHF) won a key legal victory today in a push for drug safety as well as increased government transparency when a federal court ruled 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. The description of the documents in the court ruling also implies collusion, 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.
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 unredacted 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.
"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," said Michael Weinstein, AIDS Healthcare Foundation President. "All the while, 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."
In September 2011, AHF filed 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 its potential application to expand the use of Truvada for use as a form of pre-exposure prophylaxis. Despite concerns and complaints from AHF and other advocates and the pending FOIA lawsuit, the FDA approved Gilead's application for use of Truvada as PrEP on July 16, 2012.
"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," said Tom Myers, General Counsel and Chief of Public Affairs for AIDS Healthcare Foundation (AHF). "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.54 In addition, he states, Gilead had discussions with the FDA regarding other studies conducted with Truvada that contained unfavorable results.55 Gilead and the FDA discussed how the safety and efficacy data proffered with Gilead's supplemental NDA was nonetheless sufficient to support approval.56 Pizzuti reports that these discussions were memorialized in correspondence withheld by the FDA under Exemption 4,57 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.58" [Page #19, lines 1-9 of ruling]
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AIDS Healthcare Foundation (AHF) is the largest non-profit HIV/AIDS healthcare provider in the USA. AHF currently provides medical care and/or services to more than 230,000 individuals in 28 countries worldwide in the US, Africa, Latin America/Caribbean, Eastern Europe, and Asia. Additional information is available at www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter & Instagram: @AIDSHealthcare.
AIDS Healthcare Foundation
Assistant General Counsel
Senior Director, Communications