FDA Faces Lawsuit Over Sovaldi, Harvoni Clinical Trial Data

Two patient advocacy groups are suing the FDA to force it to release raw clinical trial data on Gilead Sciences’ groundbreaking hepatitis C drugs Sovaldi and Harvoni.

The plaintiffs, a non-profit AIDS research and policy institute and a partnership hosted by Yale School of Law and Yale School of Public Health, filed the lawsuit, in U.S. district court in Connecticut, claiming public access to raw data is necessary so patients and doctors can make informed treatment decisions and cost-benefit determinations.

Full course treatments for Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) are $84,000 and $94,500, respectively.

This is not the first time a public interest group sued the FDA to gain access to Gilead drug information. In 2013, AIDS Healthcare Foundation sued to obtain documents regarding the use of Truvada (emtricitabine/tenofovir disoproxil fumarate) to treat pre-exposure prophylaxis under the Freedom of Information Act. In February 2014, federal Judge Margaret Morrow ordered the FDA to produce data supporting Gilead’s NDA pertaining to efficacy and safety along with raw, adherence and study data, diagnostic results, data interpretation records, emails and meeting documents.

The new lawsuit, Treatment Action Group and Global Health Justice Partnership v. Food and Drug Administration and Department of Health and Human Services, claims that Sovaldi and Harvoni received the FDA’s breakthrough therapy designation that streamlined approval. They are concerned that the quicker path could increase the risk that side effects or contraindications could go unnoticed.

The lawsuit, filed on June 25, seeks eight categories of information:

• All data submitted in relation to NDAs for Sovaldi and the Harvoni combination from the earliest trials onward;
• All records submitted in support of any accelerated NDAs or supplemental NDAs;
• All study protocols submitted along with the raw premarket approval and postmarket adverse event data;
• All records regarding the breakthrough therapy designation;
• All records related to trials and designs of trials, whether or not the design was approved;
• All correspondence between HHS or FDA and the company that concerns any aspect of the approval process;
• Any other raw clinical trial data submitted by Gilead in support of FDA approval; and
• All records, including clinical study reports, regarding trials of the two drugs.

The plaintiffs claim they were forced to file the suit because other methods to obtain the records, starting with a request to the company, were unsuccessful. Gilead never responded to their November 2014 letter for the clinical trial data. The drugmaker is not named as a defendant in the lawsuit.

The plaintiffs followed up with Freedom of Information Act requests to the FDA, including a request for expedited processing. The FDA responded that it would not honor expedited processing and that it would take 18 to 24 months to process the request.

The lawsuit contends that as many as 250,000 patients will be treated with these drugs in 2015, and because more than half of the patients have public insurance, the costs threaten to overwhelm state healthcare budgets.

In May, Sen. Bernie Sanders (I-Vt.), the former chairman of the Senate Veterans Affairs Committee, pressed the Veterans Administration to invoke a wartime provision to break Gilead’s patents after the VA stopped treating veterans because it had exceeded the more than $400 million budgeted for hepatitis C treatment.

The FDA does not comment on pending litigation. — John Bechtel