The US Food and Drug Administration (FDA) is facing a lawsuit for failing to respond to a freedom of information request covering a trial of two Hepatitis C drugs.
The request covers Gilead Sciences' Harvoni and Sovaldi, both of which not only have very high cure rates, but also very high costs - $94,500 for as 12-week course of Harvoni and $84,000 for Sovaldi.
The complaint argues that unless the clinical trial data is provided, safety, efficacy and cost effectiveness of the drugs cannot be fully understood.
The lawsuit's goal is to permit independent researchers to study the results and further improve patient treatment or even potentially lower the costs. Health groups are also concerned about possible ADRs, and want more information on how different groups of patients responded to the drugs in the clinical trials.
For example, there have apparently been relapses in a trial for Harvoni that were only experienced by African-Americans.
The FDA has denied the request for "expedited processing," meaning that the data could take up to 2 years to be supplied. Yale Professor Amy Kapczynski claims that "this delay will leave doctors and patients in the dark for too long." She notes that the FDA already collects the data and that prompt disclosure could have "real and immediate consequences for public health and spending."
The US industry view is that this disclosure could "compromise trade secrets" as well as patient confidentiality.
This is all in marked contrast to the situation Europe, where full disclosure is the order of the day. Last October, the European Medicines Agency adopted a new policy that clinical study reports submitted as part of a marketing application in 2015 or later will be published once a decision is made on the application. However, the EMA will allow commercially confidential information to be redacted.
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