About the Case
The Clinic represents the Global Health Justice Partnership (GHJP) and Treatment Action Group (TAG), non-profit organizations committed to advancing public health and encouraging open access to clinical trial data. GHJP and TAG are particularly interested in the data that the FDA relied upon during its approval of the latest generation of hepatitis C (HCV) drugs.
Approximately 3.2 million people are infected with HCV in the United States. Two new drugs, Sovaldi® (sofosbuvir) and Harvoni® (sofosbuvir/ledipasvir), promise unprecedented treatment success at unprecedented cost. Ordinary, twelve-week treatment plans for these drugs cost $84,000 and $94,500, respectively. Neither the FDA nor the manufacturer, Gilead Sciences, have released the raw clinical trial data that the manufacturer submitted during the approval process for these drugs. GHJP and TAG hope to make this data broadly available so that interested scientists can independently review that data and verify the drugs’ safety, efficacy, and cost-effectiveness.
Accordingly, GHJP and TAG first sent a letter to Gilead, asking them to voluntarily release the data. In December 2014, the organizations filed a Freedom of Information Act (FOIA) request with the FDA seeking disclosure of all clinical trial data associated with the drugs. The FDA’s responses estimated that it will take 18-24 months to process their requests and determine whether or not to release the data. GHJP and TAG therefore filed a civil action in June, 2014, seeking expedited processing of their request and a release of all the clinical trial data. The FDA filed a motion to stay the case in December, 2015. Oral arguments will be in September, 2016.