FDA sued over failure to disclose Sovaldi data

Two groups that campaign for wider access to medicines have filed a lawsuit against the FDA, in a bid to force the regulator to disclose the clinical trial data behind the approval of two blockbuster hepatitis C drugs.

The Yale University Global Health Justice Partnership and the AIDS non-profit charity the Treatment Action Group, have filed a joint lawsuit against the FDA claiming the US healthcare body was too slow to fully disclose key clinical trial data that led to the approvals of Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir).

These two drugs have been largely responsible for soaring recent Gilead profits. Together Harvoni and Sovaldi accounted for $4.55 billion, or 60%, of Gilead's revenue in the first quarter of 2015.

According to the lawsuit 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.

"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.

The plaintiffs said Gilead ignored its request for the trial data, while the FDA noted it would need up to two years to decide merely whether disclosure was proper to begin with. The FDA is being sued along with the US Department of Health and Human Services, which it is a part of. Gilead is not named in the complaint.

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.

In May the WHO added treatments for hepatitis C to its list of essential medicines, and “underscored the urgent need to take action to promote equitable access and use of several new highly effective medicines, some of which are currently too costly even for high-income countries.”

On the addition of hepatitis C treatments to the list, Dr Marie-Paule Kieny, WHO assistant director-general for health systems and innovation, said: “Treatments for hepatitis C are evolving rapidly, with several new, highly effective and safe medicines on the market and many in the development pipeline.

“While some efforts have been made to reduce their price for low-income countries, without uniform strategies to make these medicines more affordable globally the potential for public health gains will be reduced considerably.”

Lilian Anekwe