FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

Health groups sue FDA for Gilead hepatitis C drug trial data
BY JONATHAN STEMPEL

The Food and Drug Administration was sued by two advocacy groups seeking to force the faster disclosure of clinical trial data that helped Gilead Sciences Inc win approval for two blockbuster hepatitis C drugs.

In their June 25 lawsuit, Yale University's Global Health Justice Partnership and the Treatment Action Group, an AIDS non-profit, said doctors and patients deserve more information about the "enormously costly" drugs Harvoni and Sovaldi to make informed decisions about whether to use them.

Public health advocates and groups such as the World Health Organization have called for the broad release of clinical trial data, even if it were to compromise patient confidentiality or proprietary research.

According to the complaint filed in a federal court in New Haven, Connecticut, Harvoni and Sovaldi cost a respective $94,500 and $84,000 for 12-week regimens, straining state budgets and prompting insurers to restrict patient access.

The plaintiffs said Gilead ignored its request for the trial data, while the FDA said it would need 1-1/2 to two years to decide merely whether disclosure was proper to begin with. That's too slow, the groups said.

"Unless defendants disclose the requested information, hundreds of thousands more patients will be treated with drugs whose safety, efficacy, and cost effectiveness cannot be fully studied or understood," the complaint said.

Harvoni and Sovaldi accounted for $4.55 billion, or 60 percent, of Gilead's revenue from January to March.

The FDA is part of the U.S. Department of Health and Human Services, which is also a defendant. Gilead is based in Foster, City, California, and was not sued.

Neither the FDA nor Gilead immediately responded to requests for comment on Monday. The Wall Street Journal reported the lawsuit earlier in the day.

Hepatitis C is a liver infection often caused by the sharing of needles or other means to inject drugs. It affects about 150 million people worldwide, and kills roughly half a million annually.

Gilead won FDA approval for Sovaldi in December 2013 and Harvoni in October 2014. Sovaldi's chemical name is sofosbuvir, while Harvoni contains sofosvubir and ledipasvir.

In May, the WHO added new hepatitis C treatments to its "essential medicines" list.

The case is Treatment Action Group et al v. FDA, U.S. District Court, District of Connecticut, No. 15-00976.

(Reporting by Jonathan Stempel in New York; Editing by Richard Chang)

Source - http://www.reuters.com/article/2015/06/29/us-gilead-sciences-fda-idUSKCN0P92IZ20150629

FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data

By ED SILVERMAN

File this under ‘Show me the data.’

A pair of public health advocacy organizations has filed a lawsuit against the FDA, claiming the agency failed to release clinical trial data for Gilead Sciences GILD -3.01%’ hepatitis C treatments on a timely basis. And the move is only the latest installment in an ongoing drama in which researchers and patient advocates have tussled with drug makers and regulators over access to such information.

Here’s what happened...

Continue reading.....