A Federal Court in large part denied a Summary Judgment motion filed by the Food and Drug Administration (FDA) against AHF and ordered the FDA to provide AHF with data, documents and correspondence between the FDA and Gilead Sciences related to Gilead’s new drug application (NDA) for use of its AIDS drug, Truvada, for pre-exposure prophylaxis (PrEP) as a form HIV prevention.
U.S. District Judge Margaret M. Morrow upended previous stonewalling by the FDA and Gilead when she rejected the overwhelming majority of exemptions sought by the FDA and ordered it to produce numerous records.
WASHINGTON (February 18, 2014) AIDS Healthcare Foundation (AHF) won another key legal victory late last week in a push for drug safety as well as increased government transparency when a federal court ruled against the Food and Drug Administration (FDA) and rejected the overwhelming majority of exemptions sought by the FDA in a Freedom of Information Act (FOIA) requests tendered by AHF regarding correspondence between the FDA and Gilead Sciences related to Gilead’s new drug application (NDA) for use of its blockbuster AIDS drug, Truvada, for pre-exposure prophylaxis (PrEP) as a form HIV prevention.
In a ruling late last week, The U.S. District Court, Central District of California issued a Judgment and Order that ordered the FDA to provide AHF with data, documents, correspondence, and meeting minutes between the FDA and Gilead Sciences. Last August, AHF won an initial ruling in its FOIA case against the FDA; however, the FDA claimed exemptions for many documents. At the time, the court directed the FDA to file a Vaughn Index (a document that agencies prepare in FOIA litigation to justify each withholding of information under a FOIA exemption), and ordered the FDA to provide certain documents ‘in camera’ for inspection by the court.
In her ruling last week (CV 11-07925 MMM [JEMx]), Judge Margaret M. Morrow ordered, “That defendant FDA is ordered to produce the following records in their entirety, except for the information that this judgment specifies can be redacted. The documents the FDA is directed to produce are:
- “datasets” supporting Gilead’s NDA, which pertain to its “efficacy analysis,”
- “datasets” supporting Gilead’s NDA, pertaining to its “safety analysis”
- “safety and efficacy information” and “efficacy and safety data”
- “raw data”
- “adherence data”
- “study data”
- “diagnostic results”
- “data interpretation records”
- “second Medguides email”
- “meeting minutes documents.”
“Through her ruling, Judge Morrow’s completely upends FDA stonewalling by rejecting the overwhelming majority of exemptions sought by the FDA, and by ordering it to produce numerous records, documents, data and correspondence to AHF,” said Michael Weinstein, AIDS Healthcare Foundation President. “We suspected that the FDA colluded with Gilead to fast-track approval of Truvada as PrEP regardless of the results of clinical trials. Judge Morrow’s initial FOIA ruling last August suggested 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. Today’s ruling is an even bigger victory for increased government transparency, hampering the government’s ability to withhold information about a drug’s safety and efficacy. This ruling also brings us one step closer to finding out if our suspicions about collusion between the FDA and Gilead were justified.”
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.
“The lack of neutrality shown by the FDA throughout its dealing with Gilead on this matter is simply 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,” said Tom Myers, General Counsel and Chief of Public Affairs for AIDS Healthcare Foundation (AHF).
For more information, please visit www.aidshealth.org