FDA refused to release clinical data of hepatitis C drugs, and was sued by public organizations

Source: maimaimaitong 2015-7-7 recently, Yale University's global health justice partnership and treatment action team has filed a lawsuit against FDA to promote the disclosure of clinical trial data of two drugs of Gilead science, sovaldi and harvoni "This lawsuit is about knowledge and response," Karyn Kaplan, director of hepatitis / AIDS policy and advocacy at the global partnership for health justice, said in a press release "Based on incomplete information, key decisions are being made about who has access to treatment." The group claims that in November 2014, for the first time, they submitted a request to Gilead science for the disclosure of clinical data on sovaldi (sofibwe, Gilead Science) and harvoni (ledipasvir / sofibwe, Gilead Science), but no response has been received so far As a result, they filed a freedom of information request for FDA to disclose the information However, the FDA told them that their request could take as long as two years, and there was still no guarantee that the data would be provided to them "At that time, the FDA informed us that they would not respond within two years, so we had to file a lawsuit to enforce the public's right to know this information," Amy kapczynski, a professor at Yale Law School and director of the global partnership for health justice, said in a press release "Doctors prescribe thousands of these drugs every week, straining the budget of the national health care plan Timely disclosure of the information FDA has collected will enable doctors and decision makers to make more informed treatment choices, which has a real and direct impact on public health spending " An FDA spokesman emailed healio.com/hepatology saying the FDA "will not comment on pending litigation." The two groups filed a freedom of information request in the Federal District Court on June 25, seeking timely disclosure of clinical trial data, the press release said Tracy swan, director of the hepatitis / AIDS program of the treatment action team, said in a press release: "there is no reason for the FDA to be the only agency that has access to this information." In December 2013, the FDA approved sovaldi for the treatment of HCV In October 2014, the FDA approved harvoni, the first compound drug to treat chronic HCV genotype 1 without interferon and ribavirin.