Health Groups Sue FDA for Sovaldi/Harvoni Clinical Trial Data

July 9, 2015 — Two public health groups have sued the FDA to obtain access to the information Gilead Sciences submitted to gain approval for Harvoni and Sovaldi, two new hepatitis C drugs.

The drugs are more than 90% effective at curing people with hepatitis C within three months, and with few side effects compared to other treatments. But with a price-tag topping $1,000 per pill — around $90,000 for a full course of treatment — almost none of the estimated 3 million Americans with hepatitis C can afford the cure they need.

Treatment Action Group (TAG) and the Yale-backed Global Health Justice Partnership (GHJP) asked Gilead to release data on Sovaldi and Harvoni back in November 2014. They were ignored.

In December 2014, they filed a Freedom of Information Act (FOIA) request, but the FDA said it could take up to two years to get a response, and even then, there is no guarantee the data will be released.

Now, the groups have filed a federal lawsuit (PDF) in Connecticut to enforce the request and seek prompt disclosure of the data, according to the Information Society Project at Yale Law School.

Amy Kapczynski, a Yale Law School professor and director of GHJP said:

“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.”

The groups are seeking public access to raw clinical trial data so doctors and patients can make informed treatment decisions and cost-benefit decisions. Currently, there has been no independent analysis of data that led to the approval of Sovaldi and Harvoni.

This has left state healthcare programs and private insurers to decide how to prioritize access to the drugs, which has led to non-evidence based restrictions on treatment.

Most state Medicaid programs and many private health insurers have been denying coverage for Sovaldi and Harvoni unless a patient has end-stage fibrosis or cirrhosis of the liver. Hepatitis C is an often deadly disease, but it can take decades before chronic liver inflammation causes fibrosis or cirrhosis. In the meantime, patients suffer from debilitating symptoms of their declining health and risk transmitting hepatitis C to other people.