Intended for healthcare professionals


Lawsuit seeks access to data from hepatitis C drug trial

BMJ 2015; 350 doi: (Published 30 June 2015) Cite this as: BMJ 2015;350:h3564
  1. Michael McCarthy
  1. 1Seattle

Two health advocacy groups have filed suit to compel the US Food and Drug Administration to release clinical trial data submitted to the agency for the approval of the hepatitis C drugs sofosbuvir and sofosbuvir with ledipasvir. The plaintiffs also seek all FDA records relating to the clinical trials and correspondence between the agency and the US Department of Health and Human Services with companies developing the drugs.

The suit, which was brought by the Treatment Action Group, an HIV and AIDS advocacy group, and the Global Health Justice Partnership, an initiative of the Yale Law School and School of Public Health, was filed in US District Court District of Connecticut on 25 June.1

The plaintiffs contended that an independent review of the data was needed because both …

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