FDA vows to combat high drug prices and companies 'gaming the system' - (CNN Money via NewsPoints Desk)

  • In an interview with Kaiser Health News, FDA Commissioner Scott Gottlieb said he will do everything "within my lane" to fight high drug prices, adding that he sees pharmaceutical companies "gaming the system to try to block competition" in various ways, reported CNN Money.

  • Gottlieb also indicated that he wants to speed up the US approval process for generics and biosimilar versions of biologic drugs. "I think we should have a free market for how products are priced," he said, "but that system is predicated on a premise that when patents have lapsed you'll have vigorous competition from generic drugs."

  • The FDA is now exploring whether generics makers could buy the drugs they need in the less-expensive European market without having to do additional work to prove the biologics from Europe are the same.

  • Gottlieb indicated that he wants to eliminate so-called "bridging" studies, saying "I have lawyers now looking at this." The FDA has been exploring the issue for a couple of months, he said, adding it may be "hard for us to get there without legislation, but we're not done yet looking at this."

  • Meanwhile, the agency's Center for Drug Evaluation and Research approved a record 46 new drugs in 2017, not including landmark gene and cellular therapies and vaccines that are regulated as biologics. That rate of approvals has raised concerns about the value and quality of drugs being approved. Specifically, criticism of the FDA's handling of cancer drugs has increased in recent years.

  • However, Gottlieb defended his agency's approval of drugs that help the average cancer patient live just two or three extra months. He said if you "try to have all that information upfront when you approve a drug, [you'll] end up having a development process that is very long and very costly and a lot fewer products will be developed."

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