The new man in charge at the U.S. Food and Drug Administration knows the tricks the pharmaceutical industry often plays to increase profits.
Commissioner Dr. Scott Gottlieb's ties to the industry were one of the criticisms of his assuming the post. 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 drug makers raise to giving access to their medicines to generic drug makers 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 Gottlieb says branded drug makers sometimes abuse the REMS system to deny generic manufacturers access to their medicines
His remarks make mention of generic drug makers being able to 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.
There is 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.
U.S. 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, appears to be tackling both.
