FDA Sued Over Approval Of Hepatitis C Trial Drug

Two advocacy groups are very upset with U.S Food and Drug Administration’s decision to fast forward the publication of the clinical trail data that helped Gilead Sciences Inc win approval for two of their hepatitis C drugs.

Yale University’s Global Health Justice Partnership and the Treatment Action Group (an non-profit AIDS organization) are suing FDA on grounds of lack of information provided for the two drugs, Harvoni and Sovaldi.

They stated in their June 25th lawsuit that doctors and patients need to have more awareness about the expensive drugs before they start prescribing/using them.

The World Health Organization has called for the release of the clinical trail data even if it results in a breach of patient confidentiality or propriety research.

Complain filed in federal court in New Haven states that Harvoni and Sovaldi each cost a staggering $94,500 and $84,000 for 12 weeks of treatment. This out a huge strain on the strain budget and prompts insurers to restricts patient access.

FDA responded in saying that it requires 1 ½ to 2 years to decide whether it is okay to disclose the information, meanwhile Gilead has ignored requests for handing out the clinical trail data.

The complaint in court stated, “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.”

60% of Gilead’s revenue was derived, from January to March, by the two drugs. The company made $4.55 billion from Harvoni and Sovaldi.

Gilead, based in California, was not sued. Only FDA is on trail.

The approval of Solvadi came in December 2013 and Harvoni was approved in October 2014.

New hepatitis C treatments were included in ‘essential medicines’ list in May by the WHO.
The case is Treatment Action Group et al v. FDA, U.S. District Court, District of Connecticut, No. 15-00976.

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