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Gottlieb heading to FDA after clearing Senate vote

Trump’s favoured candidate received bipartisan support despite criticism

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The FDA will soon have a new Commissioner after Scott Gottlieb was approved by a 57-42 Senate vote yesterday.

President Donald Trump's favoured candidate for the top role at the FDA was confirmed by the Senate despite criticism of his close ties to the pharma industry by some Democrat lawmakers and academic researchers, and he ultimately received bipartisan support in the vote.

A medical doctor, former FDA deputy commissioner and health policy expert, Gottlieb certainly has the CV for the role but his numerous seats on the board of pharma companies and biotech investment funds raised concerns, particularly as - like Trump - he has been an advocate of cutting regulations at the FDA.

In March, he delivered an extensive pledge to recuse himself from FDA decisions affecting businesses in which has held an interest and would divest holdings in some companies if he was elected FDA Commissioner. That seems to have alleviated concerns in the Senate, despite close questioning about 22 firms not mentioned in his letter to Elizabeth Fischmann, the head of ethics at the Department of Health and Human Services (DHHS).

It remains to be seen whether Gottlieb will see eye to eye with Trump's plans to slash review times at the FDA for new therapies and - notably - repeal two regulations for every new one introduced at the agency.

Senate Health, Education, Labor and Pensions (HELP) committee chairman Lamar Alexander said in a statement that Gottlieb "will help American families benefit from the promise of 21st Century cures", referring to an act passed last December that will shake up the operations of the FDA and lead to the introduction of new mechanisms to speed the approval of new pharmaceuticals and medical devices.

He also said that under Gottlieb's leadership the FDA would be able to "capitalise on the significant funding Congress has given to medical research" in its latest budget deal. Agreed a few days ago, that round gave the National Institutes of Health a $2bn funding increase for the second year in a row, and rejected President Trump's push for a sizeable cut in the NIH budget.

"I look forward to working with Dr Gottlieb on a successful implementation of the Cures law to help virtually every American live a healthier life, and on a prompt reauthorisation of the medical product user fee agreements before the August recess," said Sen Alexander.

"Dr Gottlieb is the right pick to lead the FDA, and we are fortunate he is willing to serve."

Article by
Phil Taylor

10th May 2017

From: Regulatory

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