The Global Health Justice Partnership and Treatment Action Group have filed a lawsuit against the Food and Drug Administration for access to data on the hepatitis C drugs sofosbuvir (Sovaldi) and sofosbuvir/ledipasvir (Harvoni), according to a press release from Yale Law School, New Haven, Ct.
Sofosbuvir and sofosbuvir/ledipasvir were given Breakthrough Therapy Designation status by the FDA in December 2013 and October 2014, respectively, and since that time, have been used to treat more than 210,000 people. Both drugs are extremely effective, but their cost is tremendous, with the initial pricing of a 12-week treatment regimen at $84,000 and $94,500, respectively.
The two groups contacted Gilead Sciences for data on both drugs in November 2014, but received no response. In December 2014, GHJP and TAG submitted a Freedom of Information request to the FDA but were informed they would not get a response for 18-24 months and did not guarantee the data would ever be released.
“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,” Karyn Kaplan, TAG’s International Hepatitis/HIV Policy and Advocacy director said in the press release.
Read the full press release on the Yale Law School website.