The U.S. Food and Drug Administration is making it easier for generic drug manufacturers to create their own risk programs in an effort to thwart a blocking tactic used by brand-name companies to forestall competition.
The FDA has issued new guidelines spelling out how and when generics makers can seek waivers from the agency that would allow those companies to develop their own risk evaluation and mitigation strategy, or REMS, plans, which are required programs to ensure that a medicine's benefits outweigh its risks.
The regulator requires REMS when a drug is associated with serious risks.
But FDA Commissioner Scott Gottlieb said the agency is aware of situations where innovators exploit those programs to subvert competition from their generic rivals.
The FDA in May already took one action aimed at deterring innovator drugmakers from gaming the REMS system by identifying companies that try to use the programs to prevent generic manufacturers from obtaining the samples they need to conduct bioequivalent studies for U.S. approval.
Gottlieb said he was not trying to shame those innovators by naming them on a public website but was trying to discourage them from engaging in those tactics.
Stalling negotiations
But the commissioner said another way brand-name companies are using REMS to obstruct competition on the back end of the process is by dragging out negotiations with generics makers on developing a shared risk program.
Generics companies are required by law to have the same REMS as the brand-name manufacturer when the program includes certain requirements known as elements to assure safe use, or ETASU.
The FDA, however, is permitted to waive the requirement for the shared REMS and can permit the generics company to use a separate comparable risk program.
"The REMS shouldn't become a tool that drug companies can use to delay or block competition from generic products or hinder their ability to enter the market," Gottlieb said in a May 31 statement.
The FDA chief had first acknowledged during a May 14 media briefing that he planned to issue the REMS waiver guidelines.
"Just by signaling that we are going to be willing to give waivers more easily to generic manufacturers, that's going to cut down this sort of gaming," he told reporters.
Gottlieb said the unmasking of the system-gamers and the new waiver guidelines were part of the Trump administration's strategy to lower drug prices, unveiled May 11.
President Donald Trump on May 30 said he will reveal in two weeks the identities of a group of "big" drugmakers that have committed to lowering their prices because of his plan.
Going it alone
Under the FDA's new waiver guidelines, the agency may permit generics companies to use a different, comparable aspect of the ETASU if regulators find that the burden of forming a single shared REMS outweighs the benefits of having one, Gottlieb explained. The regulator may also use such flexibility if an aspect of the risk program is covered by a patent or is a trade secret and the copycat rival certifies that it sought a license for use of that aspect and was unable to obtain it.
While the FDA encourages companies to work together to form a shared REMS, the commissioner said regulators would consider a waiver at any time — either on the generics company's request or on the agency's own initiative.
"Our safety programs shouldn't be leveraged as a way to forestall generic entry after lawful [intellectual property] has lapsed on a brand drug," Gottlieb said.
Shared REMS clarity
The FDA also issued new guidelines describing the general principles and recommendations to assist drugmakers with developing shared REMS, with the goal of improving the clarity and efficiency of a single program, which Gottlieb said would enable timelier market entry.
"We believe that by making the process for developing a shared system REMS more efficient, we'll discourage brand drugmakers from using REMS as a way to block generic entry and help end some of the tactics that can delay access," he said.
The U.S. market-based system for rewarding innovation is dependent on legal competition, Gottlieb said.
"That system enables market-based rewards for novel innovation as a way to create incentives for the time, risk and capital required to develop new medical advances," he said. "At the same time, the law allows for brisk competition from safe and effective generic medicines once the period of patent protection or exclusivity has lapsed on a new medicine."
