It’s very early in Scott Gottlieb’s tenure at the FDA, but I like what he has to say about generic drug approvals. Several times here, I’ve gone on about how a lot of the terrible pricing situations we’re seeing in generics are due to gaming of the regulatory system, and how the FDA could do a lot to keep such things from happening. It looks like Gottleib agrees – he’s told Congress that he would like to:
— “Curtail gaming by industry of our regulations which can extend monopoly periods beyond the time frame Congress intended, hindering competition.”
— “Improve the processes that enable generic versions of complex drugs to be approved for marketing.”
— “Increase the overall efficiency of the generic drug review process while completely eliminating the backlog of generic applications.”
The REMS program (risk evaluation and mitigation strategies), he noted, has been used to slow generic competition, and streamlining the process by waiving the requirement that a generic and brand manufacturer share a single system for assuring safe use could be used to eliminate one tool used to slow generics.
Good. The generic drug system is supposed to provide cheap, readily available drugs that have gone off patent, but it’s turned into a place to game the system in order to jack up prices on old drugs. If Gottlieb can clean that up, more power to him, because it’s giving the entire industry a black eye. Remember, the general public does not distinguish between generic manufacturers and the companies that bring new research-driven drugs to market. We’re all “the drug industry”, and we all look bad when any companies pull these stunts.