Regulatory Focus™ > News Articles > Advocacy Group Pries Additional Details from FDA About Approval of AIDS Drug Truvada

Advocacy Group Pries Additional Details from FDA About Approval of AIDS Drug Truvada

Posted 19 February 2014 | By Alexander Gaffney, RAC

The AIDS Healthcare Foundation (AHF), a DC-based advocacy group, has won yet another legal battle against the US Food and Drug Administration (FDA), forcing it to turn over significant documents related to the approval of Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/ emtricitabine).

Background

The legal victory for AHF is its second in the last year.

In 2013, FDA announced it would expedite the review of Truvada based on its expected clinical utility and ability to meet an unmet need. When taken regularly, the drug is supposed to prevent the spread of HIV, even when a patient is exposed to the virus.

While the drug's review was eventually extended by an additional three months, thereby erasing any benefit of an expedited review, AHF was still opposed to its approval. The group said it was concerned about the "significant risk of kidney disease and damage" to patients taking the drug, as well as a lack of confidence in the studies used as the basic of approval for the drug. Those studies also raised questions about the effectiveness of the drug in women, the group said in a Citizen Petition that was ultimately denied by FDA.

Read more on the saga in Focus' August 2013 article, "AIDS Group Wins Bid to Obtain 'Confidential' Data Analysis, Summaries About HIV Drug from FDA"

After the drug was approved by FDA in July 2013, AHF sued the agency, seeking to find out the extent of communications between FDA and Gilead and the contents of redacted safety and efficacy data, as well as data summaries and other internal documents.

On 7 August 2013, the group announced that it had largely prevailed in this fight, with the US District Court of Central California ruling that FDA needed to turn over "complete and un-redacted copies of documents" related to Truvada's approval to AHF.

Some documents, however, were left out of that agreement after the presiding judge determined that FDA should have more time to argue for their exemption.

As Focus wrote at the time, the decision could be seen as significant in that it would seem to be a route toward clinical data transparency. And as Focus postulated at the time, the court decision likely wasn't the last time we would hear from AHF on the topic of Truvada.

Victory for AHF

And sure enough, we were right. In a statement released on 18 February 2014, AHF announced that it had again prevailed in a fight against FDA to release more of the data it had originally sought from the agency through a Freedom of Information Act (FOIA) request.

"The US 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," AHF wrote.

The new court decision adds on the group's 2013 victory by forcing FDA to hand over numerous documents containing the following:

  • "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"

While some documents will continue to be redacted in part to protect trade secrets, the sum total of AHF's two legal victories means it will have access to nearly all of the documents used to support FDA's approval decision, including many of the agency's draft deliberations regarding the approval decision. Those documents could be used to substantiate doubts and allegations against 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," said AHF president Michael Weinstein in a statement. "This ruling also brings us one step closer to finding out if our suspicions about collusion between the FDA and Gilead were justified."

Weinstein and AHF have previously called for FDA Commissioner Margaret Hamburg to resign, and have also been vocal critics of the agency's treatment of Truvada since at least September 2011, when it first sued the agency regarding a attempts to expand the drug's approved indication to include PrEP.

 

AHF Statement


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