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- 03/13/2017

Trump’s choice for FDA leader gives a sigh of relief

Pharma Horizon

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The American Enterprise Institute photo of Scott Gottlieb

Dr. Scott Gottlieb is seen in this American Enterprise Institute photo released in Washington, DC, U.S., March 10, 2017. Courtesy The American Enterprise Institute/Handout via REUTERS

The choice of U.S. President Donald Trump to run the FDA has been revelead on Friday: is  Dr. Scott Gottlieb, 44,  a conservative health policy expert with deep ties to the pharmaceutical industry and who served as a top official at the agency during the administration of President George W. Bush

 

The nomination, that has still to be confirmed by the Senate, but so far has drawn praise from industry executives: 

“Thank God it’s Gottlieb,” Brian Skorney, an investment analyst at Robert W. Baird, wrote in a research note. “We view this as a favorable development for the sector.”

Gottlieb was chosen over Jim O’Neill, whose stated view that drugs should be approved before being proven effective generated widespread alarm.

Gottlieb’s cv includes  being a  resident fellow at the conservative American Enterprise Institute think tank and also being a partner at a large venture capital fund. He is also a former FDA deputy commissioner who has advocated a loosening of requirements needed for approval of new medical products.

However on the other side such experience has been sharply criticized from consumer advocates who said he is too deeply tied to the industry.

Nonetheless, even if Dr. Gottlieb views are seen as more moderate than Jim O’Neill ones,  he is expected to bring significant change, including moving the agency to increase flexibility in the clinical trial development process.

He is very keen on to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics  and also wrote in the past that the agency could help reduce the price of old drugs that have lost their patent protection by loosening the rules governing generic drugs.  He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards.

That was one of the central issues for Republicans  and in February, House Republicans has introduced a bill that would also streamline the process. 

 

Gottlieb “has firsthand experience at the FDA and as a physician that has treated patients understands the breadth of work that needs to be achieved on their behalf,” said Ellen Sigal, founder of Friends of Cancer Research.

Dr. Gottlieb, if confirmed, would head a sprawling agency that oversees everything from drugs and medical devices to tobacco, food and cosmetics. Products regulated by the agency account for 20 cents of every dollar spent by American consumers each year.

 

Source: The New York Times



 

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