Public Health Groups Sue FDA For Disclosure of Clinical Trial Data for Costly Hep C Drugs

FOR IMMEDIATE RELEASE: June 25, 2015
CONTACT:    Debra Kroszner, (203) 432-1053, debra.kroszner@yale.edu

Public Health Organizations File Federal Lawsuit Seeking Access to Clinical Trial Data for Costly Hepatitis C Drugs

NEW HAVEN, CT—Treatment Action Group (TAG) and the Global Health Justice Partnership (GHJP) have filed a federal lawsuit to obtain access to the information that Gilead Sciences submitted to the FDA to obtain approval of two new—and extremely expensive—hepatitis C drugs, Sovaldi (sofosbuvir) and Harvoni (sofosvubir/ledipasvir).  Hepatitis C affects at least 3 million people in the United States. Sovaldi and Harvoni significantly improve cure rates, but initial pricing was unprecedented: $84,000 and $94,500 for a 12-week course of treatment, respectively. 

In November 2014, TAG and GHJP asked Gilead Sciences to release the data on Sovaldi and Harvoni that was submitted to FDA, as other pharmaceutical companies have done. They received no response. As a result, in December 2014, TAG and GHJP filed a Freedom of Information (FOIA) request, seeking access to this information from the FDA.

Remarkably, the FDA has informed the groups that they should not expect to receive a response for 18 to 24 months and have made no guarantee that the data will even be released then. 

“There is no reason why the FDA should be the only one with access to this information,” explained Tracy Swan, TAG’s Hepatitis/HIV Project Director.  

“This delay will leave doctors and patients in the dark for too long,” says Amy Kapczynski, a Yale Law School professor and director of GHJP. “Doctors write thousands of prescriptions for these drugs every week, straining budgets of state healthcare 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. When the FDA informed us that they would not get to our request for two years, we had no choice but to file a lawsuit to enforce the public’s right of access to this information.”

GHJP and TAG filed suit today in federal district court in Connecticut to enforce their FOIA request and seek prompt disclosure of the clinical trial data.  Yale Law School’s Media Freedom and Information Access Clinic (MFIA Clinic) represents GHJP and TAG in the litigation. The MFIA Clinic is a program of Yale Law School Information Society Project’s Abrams Institute for Freedom of Expression.

Karyn Kaplan, TAG’s International Hepatitis/HIV Policy and Advocacy Director, adds, “This lawsuit is about access and answers. The astronomical price of these drugs requires Medicaid programs and other providers to make hard choices about how to allocate their resources. They are making these decisions now. Crucial policy determinations about who has access to treatment are being made on incomplete information.”

“If this drug is as promising as it appears to be, what does the FDA have to hide?” asks Gregg Gonsalves, co-director of GHJP. “Independent scrutiny will ensure that any unresolved safety and efficacy concerns are brought to light as quickly as possible.”

The FDA granted both drugs Breakthrough Therapy Designation status, which put them on an accelerated pathway to approval.  Sovaldi was approved in December 2013, and Harvoni in October 2014. Since then, more than 210,000 people have been treated with these drugs, including members of patient subpopulations that were little studied in clinical trials. Dr. Doug Bruce, Chief of Medicine at Cornell-Scott Hill Medical Center and Associate Clinical Professor at the Yale School of Medicine, observes, “It’s good to get drugs on the market quickly for people who need them, but when the approval process is so accelerated, it is especially important that the public has access to raw data to allow independent oversight of the FDA’s safety and efficacy determinations. Raw clinical data allows clinical providers the opportunity to make the best decisions for their patients.”

There is a growing consensus in the medical community about the importance of open access to clinical trial data, says Dr. Bruce. “The FDA and the companies who conduct the studies make choices throughout the approval process about the design of clinical trials, how to interpret the raw data, and when to extrapolate conclusions about one group of people with specific characteristics based on studies of another, different population. These choices impact the FDA’s decisions about whether to approve drugs, and its recommendations about how they should be used. In order to evaluate the strength of the FDA’s recommendation and decide how to use drugs with real-life populations, it is essential to have independent analysis of the raw clinical trial data.”

TAG is an independent AIDS research and policy think tank dedicated to fighting for better treatment, vaccines, and cures for HIV-related diseases. TAG’s Hepatitis/HIV Project collaborates with activists, community members, scientists, governments, and drug companies to make safer, more effective, and less toxic treatment for viral hepatitis available to all who need them. More information about TAG’s efforts related specifically to HCV is available at http://www.treatmentactiongroup.org/hcv and http://www.hepcoalition.org/.

GHJP is an initiative of the Yale Law School and Yale School of Public Health dedicated to promoting improvements in health systems and health justice. As a science-based, nonprofit initiative, GHJP’s primary objectives are to facilitate open science, community engagement, and public health. This year, GHJP released a report together with TAG examining barriers to HCV treatment access.

TAG and GHJP are represented by law student interns Amanda Lynch and Ben Picozzi, and supervising attorneys Jonathan Manes and David Schulz of the Media Freedom and Information Access Clinic.  The MFIA Clinic is a program of the Yale Law School Information Society Project’s Abrams Institute for Freedom of Expression.  A copy of the complaint can be found here, along with a copy of the FOIA request and correspondence with the FDA.