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Trump’s FDA nominee demand to lower drug costs by approving more generics

 

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The choice of President Donald Trump to head the US Food and Drug Administration is among the strongest advocates of lowering drug costs by quickly approving cheap generics, an initiative aimed directly at profit centers Of large companies.

Getting more generic products on the market faster could save billions of US dollars a year, and a more aggressive FDA approach would fit into Trump's promise to provide relief. At a White House meeting on January 31, the president called the "astronomical" awards and said that competition would lower them.

Scott Gottlieb, former Deputy Commissioner of the FDA, would make rationalization of approvals his top priority, according to a person familiar with the administration's thinking. It is particularly focused on complex medicines that combine old drugs with new delivery devices, as well as those with abnormally complicated formulations.

"This is an opportunity for a new administration to make a mark, to do something about an issue where there is a significant amount of public interest," said Jack Hoadley, an analyst and professor at Georgetown Health Policy University Institute in Washington. While the FDA commissioner has wide latitude, "the evidence is in action. You have to show that there is something real behind it. "

 

The administration could make the changes without Congress passing a law. This would allow the administration a badly needed victory as a result of its collapsed attempt to repeal the Affordable Care Act, a central element of the Trump campaign and the Republican agenda. But it also anger businesses that have considerable legal firepower to defend their decision makers.

The main generic drug law, crafted more than 30 years ago, “didn’t contemplate these ‘complex’ drugs, and so it doesn’t provide for an efficient and predictable path for enabling generic entrants,” Gottlieb wrote in an Oct. 24 Forbes.com column.

In a March 6 speech in Orlando, Fla., before his nomination was announced, Gottlieb talked about overhauling rules that have let brand-name companies create “monopolies in perpetuity.”

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