Health advocacy groups sue FDA for Gilead's hep C data
- Two non-profits are trying to force the FDA to disclose clinical trial data on Gilead's Sovaldi and Harvoni.
- At issue is the cost of these oral hep C drugs, which cost $84,000 and $94,500, respectively, for 12-week regimens.
- The contention is that if physicians have access to more of the clinical trial data on these two drugs, they will be empowered to make better decisions—which is especially important given the cost of the medications.
The cost conundrum around Gilead's hep C drugs is not going away anytime soon. Everyone, it seems, from private payers, to the World Health Organization, to government payers, and now Yale University's Global Health Justice Partnership and the Treatment Action Group, an AIDS non-profit, have weighed in on how expensive these drugs are. In fact, for the first quarter of 2015, Gilead had revenues of $4.55 billion just from Sovaldi and Harvoni. That's 60% of the company's first-quarter revenues.
The FDA has said that it could take up to two years to determine whether it's even appropriate to disclose the data, which set off alarm bells for the plaintiffs. So now the question is, how exactly will having this data empower physicians and give them any more information than they can get from the published literature, the Product Information, or the pivotal data—all of which are already available?
It's well known that pharma companies don't make all of their data available all the time. There is the possibility that there are data in which specific subpopulations of patients fared better on one regimen versus another—or cases in which certain patients were not likely to have a cure (a very rare outcome given the high cure rate).
Regardless, clinical trial data should be available to facilitate the best decision-making possible, especially given the high costs of speciality drugs like Sovaldi and Harvoni.