Speaking at a Federal Trade Commission meeting on competition in prescription drug markets, Gottlieb noted that drug companies sometimes prolong negotiation over terms of a shared REMS as a tactic to delay approval of generic drugs. To counter such practices, he said FDA is making it easier for sponsors of innovative drugs to cooperate with generic companies to implement a common master file for the implementation of a REMS.
The common REMS master file is a “first step toward making it easier to implement a single shared REMS,” Gottlieb said.
FDA published draft guidance entitled “Use of a Drug Master File for Shared System REMS Submissions” in the Federal Register Wednesday.
While a shared REMS will make it easier for providers to comply with the risk mitigation programs, they can also be used to prevent drug companies from prolonging negotiations with generic companies, Gottlieb said. “Our goal is to see sponsors share REMS systems to reduce burdens on providers. But when branded drug makers drag out these negotiations -- sometimes as a way to forestall generic entry -- we’re going to be in a stronger position now to say enough is enough.”
If branded companies fail to agree on terms of a shared REMS, FDA will “have a stronger basis to issue a waiver that will allow the generic drug makers to go their own way if they have to, and develop their own REMS,” he said at the FTC meeting. In a statement issued to media, Gottlieb said FDA plans to provide more information on how and when generic companies can request a shared REMS waiver and the factors FDA intends to consider.
At the meeting, Gottlieb also vowed to use FDA’s bully pulpit to deter supply chain intermediaries like specialty pharmacies from helping pharma companies deny generic manufacturers access to samples that are needed to conduct FDA-required tests. Gottlieb said he is “going to contact pharmaceutical supply chain intermediaries to inform them of the FDA’s interest in making sure that generic firms can gain access to the doses they need to run bioequivalence studies. When intermediaries sign on to these restrictive games, I want them to know that they’re challenging a broader public health goal.”
Gottlieb made a public health case for competitive drug markets. “Our economic model, which rewards highly innovative drugs with the opportunity to hold monopolies for a limited period of time through patents and exclusivities, and to freely price their products to a measure of the value that a transformative drug offers, also depends on the generic approval process working as intended,” he said. “It depends on the ability to have vigorous competition once those patents and exclusivities have lapsed.”
Comments on the draft guidance are due in 60 days.