FDA Slow to Hand over Gilead Hepatitis C Trial Data, Advocacy Groups Allege

The U.S. Food and Drug Administration (FDA) is being sued by two consumer advocacy groups who allege that the agency is too slow to hand over clinical trial data for two of Gilead’s hepatitis C drugs. The lawsuit was filed by Treatment Action Group and the Global Health Justice Partnership, the Wall Street Journal reports.

The lawsuit involved clinical trial data for Sovaldi and Harvoni, which are prescribed frequently due to a high cure rate. The groups asked Gilead for patient-level trial data on the treatments because they were approved through an expedited process known as breakthrough designation. The groups are worried that this type of approval “may increase the risk that gaps in drug efficacy will go undiscovered, or that side effects or [interactions with other drugs] will go unnoticed,” the lawsuit alleges. “Independent analysis of patient-level clinical trial data is essential to identify and bring to light unresolved safety and efficacy issues.”

Treatment Action Group and the Global Health Justice Partnership want to further investigate data looking at how different groups of patients responded to the treatments during clinical trials. Treatment Action Group’s Tracy Swan said that in Harvoni trials, relapses seemed to occur only among African-Americans. Furthermore, the groups want to analyze poor prognostic factors among patients who were not cured by the drugs.

When Gilead did not respond to the data request, the groups looked to the FDA and submitted a Freedom of Information request. The data was submitted to the agency as part of the approval process. The groups asked for “expedited processing” in the situation, which the FDA denied, stating that it would take take 18 to 24 months to turn over the data. Amy Kapczynski, a professor at Yale Law School who heads GHJP, said in a statement “This delay will leave doctors and patients in the dark for too long,” according to WSJ. “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.

Physicians “lack the benefit of any independent assessment of the data.” according to the lawsuit. The groups state that it is “crucial that policymakers be able to evaluate the cost-effectiveness… based on the underlying clinical data…” since the drugs are so expensive. Prior to discounts, the price of 12-week treatments with Sovaldi and Harvoni are $84,000 and $94,500.

“To an extent, this is part of the larger quest to obtain data and open up trials,” says GHJP’s Gregg Gonsalves, according to WSJ. “There is no smoking gun. We’re not asking because we think there’s some horrible side effect lurking in the data. But the drug was studied for a certain set of patients and is being used for a wider set of patients. Maybe there’s nothing new, but I think we have a right to see what’s there.”

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