The Treatment Action Group and Yale’s Global Health Justice Partnership say the drugs “promise not simply better treatment for HCV, but a cure.”
The FDA approved Sovaldi (sofosbuvir) in December 2013 and Harvoni (sofosbuvir/ledipasvir) in October 2014, for the debilitating, potentially fatal liver disease.
Both drugs are extremely expensive.
A full, 12-week course of Sovaldi costs $84,000 and Harvoni costs $94,500.
More than half of the estimated 3.2 million people in the United States with hepatitis C are publicly insured, so the cost of the drugs will affect state healthcare budgets, according to the June 25 federal complaint.
The FDA does not release clinical trial data to the public, as drug makers demand profits, or at least compensation, for their research and development, and patent protection. Release of such information could help rivals create similar drugs of their own.
Because hepatitis C affects so many people, the plaintiffs say: “Public disclosure of this data – with appropriate redactions to protect patient privacy – is mandated by the Freedom of Information Act and is essential to enable independent review by outside scientists, researchers, public health organizations, patient advocates, and others.” At the very least, they say, the data should be available to “the scientific community.”
The Treatment Action Group is a nonprofit institute seeking treatment for HIV and AIDS.
The Global Health Justice Partnership is backed by the Yale Law School and Yale School of Public Health.
Though the FDA has approved use of the drugs, in April it issued a warning that both drugs could slow the heart rate if patients also take amiodarone, an anti-arrhythmia drug. The warning came after reports that nine patients suffered complications when taking both drugs.
“The reports included the death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker to regulate their heart rhythms,” the FDA said.
The plaintiffs say this may indicate that the FDA did not require enough clinical testing before approving the drugs for the market.
“Flaws in the design, publication, and analysis of clinical data for new drugs may obscure critical safety and efficacy issues,” the complaint states.
The plaintiffs filed Freedom of Information Act requests in December 2014 with the Food and Drug Administration and the Department of Health and Human Services, seeking the clinical data.
The FDA denied the request within a week, and the HHS has merely acknowledged receipt of the request.
In January the plaintiffs filed an administrative appeal with Office of the Assistant Secretary for Public Affairs, and the FDA responded by providing approval data, but not the requested patient-level safety and efficacy data.
The plaintiffs seek expedited response to their FOIA requests.
They are represented by Jonathan Manes with the Yale Law School’s Media Freedom and Information Access Clinic.
The FDA and HHS did not respond to requests for comment.
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