FDA moves to increase generic competition

Scott Gottlieb

Chip East | Reuters
Scott Gottlieb

New Food and Drug Administration Commissioner Dr. Scott Gottlieb knows the tricks the pharmaceutical industry often plays to increase profits.

His ties to the industry were one of the criticisms of his appointment. But now he’s using that knowledge to take actions to curb what he calls “gaming” of the system that keeps costs high.

In remarks released by the FDA Tuesday ahead of a public meeting on competition for generic drugs, Gottlieb outlined some additional ways the regulator plans to speed those cheaper medicines to market.

One takes aim at objections branded drugmakers raise to giving access to their medicines to generic drugmakers working on copies that would bring costs down.

Often, distribution of medicines is controlled tightly due to safety concerns under programs known as REMS: Risk Evaluation and Mitigation Strategies. But branded drugmakers sometimes abuse the REMS system to deny generic manufacturers access to their medicines, Gottlieb said.

Generic drugmakers can obtain letters from the FDA permitting branded companies to sell them their drug for the purpose of working on a generic copy. FDA is now considering making those letters public, according to Gottlieb’s remarks.

“These letters contain important information that can help inform broader discussions about access and competition,” Gottlieb said. “Their public release could be one step to help ensure that unnecessary hurdles to generic drug development are removed.”

No talk, just yet, of making public the FDA’s communications around rejections of drug applications, known as Complete Response Letters, or CRLs. That was something Gottlieb had discussed in the past.

Another part of his plan unveiled Tuesday aims to streamline the review process for generic medicines, eliminating overlapping procedures to cut down on the time it takes to bring a drug to market.

President Donald Trump has continually returned to two major themes when it comes to the pharmaceutical industry: that prices are too high, and the FDA is too slow when it comes to approving drugs.

Gottlieb, in his first steps at the agency, is tackling both.

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