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Public Health Groups sue FDA Over Access to HCV Clinical Trial Data

The Global Health Justice Partnership at Yale University and Treatment Action Group have filed a lawsuit against the FDA in an effort to gain access to clinical trial data submitted by Gilead Sciences for sofosbuvir and ledipasvir/sofosbuvir, according to a press release.

“This lawsuit is about access and answers,” Karyn Kaplan, international hepatitis/HIV policy and advocacy director at Global Health Justice Partnership, said in the release. “Crucial policy determinations about who has access to treatment are being made on incomplete information.”

The groups allege that in November 2014, they first submitted a request to Gilead Sciences to release clinical data on sofosbuvir (Sovaldi, Gilead Sciences) and ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) and it has gone unanswered. As a result, the groups filed a Freedom of Information request, requesting this information from the FDA. However, the groups state the FDA told them their request could take up to 2 years and there is still no guarantee they would be given the data.

“When the FDA informed us that they would not get to our request for 2 years, we had no choice but to file a lawsuit to enforce the public’s right of access to this information,” Amy Kapczynski, a Yale Law School professor and director of the Global Health Justice Partnership, said in the release. “Doctors write thousands of prescriptions for these drugs every week, straining budgets of state health care programs. Prompt disclosure of this information, which the FDA already collects, will allow doctors and policymakers to make more informed treatment choices with real and immediate consequences for public health and spending.”

An FDA spokesperson stated to HCV Next via email that the FDA “does not comment on pending litigation.”

Both groups filed the suit on June 25 in federal district court in Connecticut to enforce their Freedom of Information request and seek prompt disclosure of the clinical trial data, the release said.

Tracy Swan, hepatitis/HIV project director at Treatment Action Group, stated in the release: “There is no reason why the FDA should be the only one with access to this information.”

Sofosbuvir was approved for the treatment of HCV by the FDA in December 2013. Ledipasvir/sofosbuvir, the first combination pill for treatment of chronic HCV genotype 1 that does not require interferon or ribavirin, was approved by the FDA in October 2014.

• Reference:
• Public Health Groups Sue FDA For Disclosure of Clinical Trial Data for Costly Hep C Drugs. Information Society Project, Yale Law School website. http://isp.yale.edu/node/5978. Published June 25, 2015. Accessed June 30, 2015.

Disclosures: HCV Next was unable to confirm relevant financial disclosures at the time of publication.