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 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.
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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)
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