Advocacy Groups File Lawsuit against FDA over Gilead Hepatitis C Trial DataJun 30, 2015
Two consumer advocacy groups are suing the U.S. Food and Drug Administration (FDA) over clinical trial data for Gilead Sciences hepatitis C drugs. According to the Wall Street Journal, Treatment Action Group and the Global Health Justice Partnership filed a lawsuit alleging that the FDA failed to release clinical data for Sovaldi and Harvoni in a timely fashion.
WSJ reports that Sovaldi and Harvoni are frequently prescribed due to high cure rates. These drugs were approved through breakthrough designation, which expedites the approval process. Because they were pushed through an accelerated review, the two groups asked Gilead for patient-level trial data. Treatment Action Group and Global Health Justice Partnership are concerned that the expedited 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."
According to the lawsuit, Gilead never replied to their requests for the data. The groups then looked to the FDA and submitted a Freedom of Information request since the agency received the data as part of the approval process. The groups asked for "expedited processing" in the situation, which the FDA denied, stating that it would 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."
In particular, the advocacy groups want to gather more data looking at how different groups of patients responded to the treatments during clinical trials. Treatment Action Group's Tracy Swan indicated that for Harvoni, relapses appeared to occur only among African-Americans. Additionally, the groups want to analyze poor prognostic factors among patients who were not cured by the drugs.
According to the lawsuit, physicians "lack the benefit of any independent assessment of the data." The groups also assert that since the drugs are quite expensive, it is "crucial that policymakers be able to evaluate the cost-effectiveness… based on the underlying clinical data…" 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."