FDA must publish data on safety and efficacy of prophylactic AIDS drug, court rules

BMJ 2013; 347 doi: (Published 19 August 2013) Cite this as: BMJ 2013;347:f5161
  1. Nigel Hawkes
  1. 1London

A US court has ruled that the Food and Drug Administration should release safety and efficacy records on the pre-exposure prophylactic AIDS drug, the combination of tenofovir and emtricitabine, Truvada, marketed by Gilead Sciences.

The data were sought by the AIDS Healthcare Foundation under freedom of information rules, but the FDA had denied the application on the grounds that releasing the data would compromise Gilead’s commercial position in the market.

Ruling in favour of the foundation on 6 August, US District Court judge Margaret Morrow said the FDA had failed to show that the data fell into the class that would allow this exemption from freedom of information rules to apply. She ordered the FDA to produce “complete and unredacted” copies of the data that the foundation had been seeking, which included some correspondence between the FDA and Gilead regarding the safety and efficacy of pre-exposure prophylaxis.

The foundation, based in Los Angeles, says it is the largest provider of HIV and AIDS medical care in the United States. For three years it has been fighting to prevent the FDA from approving the combination of tenofovir and emtricitabine (Truvada), marketed by Gilead as a prophylactic to HIV infection, on the grounds that a belief that transmission can be prevented will unintentionally lead users to engage in riskier sexual behaviour.

In 2011 it issued the lawsuit against the FDA. But while this suit was pending, the FDA went ahead and approved the licence for the combination of tenofovir and emtricitabine (Truvada) in July 2012. The foundation, believing that the documents it sought would reveal that the FDA had colluded with Gilead to put the best interpretation on the evidence, persisted in its action. Its success was not complete, with Judge Morrow ruling that some draft correspondence it had also sought was properly withheld as it contained incomplete agency views.

Michael Weinstein, president of the foundation, said it suspected that the FDA had colluded with Gilead to fast track approval of the combination of tenofovir and emtricitabine (Truvada) as pre-exposure prophylaxis regardless of the results of clinical trials. “All the while, the FDA was illegally denying our Freedom of Information Act 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,” he said.

Gilead responded in a statement published by the Pharmalot blog.1 “As you know, with any regulatory submission, there will be dialogue between the FDA and the sponsor company,” the statement said. “And with regard to the data, both the FDA advisory committee and the FDA felt the safety and efficacy data submitted supported the use of Truvada for pre-exposure prophylaxis.”

The ruling does not change the FDA’s criteria for exempting documents from freedom of information requests, but said that in this case they were wrongly applied. However, it could open a door to greater access to trial data, an objective being pursued on both sides of the Atlantic.2

The BMJ has put pressure on Roche to provide full disclosure of data it holds on the flu drug oseltamivir, and the company agreed in April to pass over 74 clinical study reports. It has started passing these files to researchers from the Cochrane Collaboration.

The European Medicines Agency has also adopted an open policy, which it continues despite an interim ruling from the General Court of the European Union supporting a US company, AbbVie, in an action to prevent the release of data held on the drug adalimumab (Humira), used for treating rheumatoid arthritis.3 A final ruling is awaited.


Cite this as: BMJ 2013;347:f5161