FDA faces Lawsuit from Health Groups over Gilead Hepatitis C Drug Trial Data

FDA faces Lawsuit from Health Groups over Gilead Hepatitis C Drug Trial Data

Two advocacy groups have sued the Food and Drug Administration (FDA) to enable faster disclosure of clinical trial data that helped Gilead Sciences Inc get approval for two blockbuster hepatitis C drugs.

Yale University's Global Health Justice Partnership and the Treatment Action Group, an AIDS non-profit, said in their June 25 lawsuit that it is very essential for doctors and patients to know about the highly expensive drugs Harvoni and Sovaldi in order to make informed decisions about their use.

Broad release of the clinical trial data is what being demanded by public health advocates and groups such as the World Health Organization. However, there are concerns over patient confidentiality or proprietary research.

Harvoni and Sovaldi cost a respective $94,500 and $84,000 for 12-week regimens, which shrinks state budgets and pushes insurers away from providing access to patients.

“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”, said the complaint.

From January to March, $4.55 billion, or 60%, of Gilead's revenue had come from the sale of Harvoni and Sovaldi.

Gilead got the nod from the FDA for Sovaldi in September last year and Harvoni the following month. The health groups have to say that the clinical data holds significant importance as it allows doctors and policymakers to revisit the costs of the drugs and understand possible health consequences related to the drugs. Prescription for those drugs is being written by doctors every month, which has been straining budgets of state health care programs.