FDA unveils guidance that aims to make it easier for generics to enter the drug market

The Food and Drug Administration has officially unveiled new guidance that aims to increase competition in drug markets. 

The agency released a pair of draft guidance documents that could allow generic drugmakers to apply for a waiver to the single, shared-system Risk Evaluation and Mitigation Strategy (REMS) requirement, which could help ease delays caused by prolonged negotiations between generic and branded drug companies.

FDA Commissioner Scott Gottlieb, M.D., previewed the plans earlier this month. The first guidance document (PDF) provides details on what a single, shared system REMS program should look like, while the second (PDF) outlines when the FDA will consider the waivers. 

Generic drug companies argue their brand-name peers can use REMS to hinder competition and make it harder for them to bring generics to market. Brand-name drugmakers have said there are a number of scenarios beyond gaming that could delay REMS agreements.

Gottlieb said in a statement that the goal of the new guidance is to maintain the safety protocols REMS provide while also making it easier for generics to enter the market. 

"The REMS shouldn't become a tool that drug companies use to delay or block competition from generic products or hinder their entry to the market," Gottlieb said. 

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Having a more clearly defined set of parameters for REMS should enable companies to operate better within them, according to the FDA. An efficient REMS program will promote, not hinder, drug market competition. 

However, the FDA said it will consider waivers at any time, according to the document, though it does seek to encourage companies to effectively band together under the shared REMS system first. 

"Our safety programs shouldn't be leveraged as a way to forestall generic entry after lawful [intellectual property] has lapsed on a brand-name drug," Gottlieb said. "Our market-based system for rewarding innovation is dependent on this kind of legal competition." 

The FDA rolled out its first initiative under the Trump administration's "American Patients First" blueprint to reduce drug pricing in mid-May, when it launched a website that would detail which brand-name drugs generic drug companies had the hardest time accessing. 

Gottlieb said at the time the website would ensure "branded companies are on notice" for behavior that could hold generic drugmakers back. 

The FDA is also planning to reveal policies that overhaul its drug approval process in early June, Gottlieb said. 

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Department of Health and Human Services Secretary Alex Azar praised the FDA's actions in a statement, saying the agency will "continue taking action to promote competition." 

"The FDA's announcement today will help generic drug manufacturers bring low-cost competition to market faster and discourage brand-name companies' misuse of laws meant to protect public health," Azar said. "Greater competition in drug markets is one of the key pieces of our plan to bring down drug prices."