Gottlieb confirmation as FDA commissioner warmly welcomed by biopharma

New FDA commissioner Scott Gottlieb

As expected, Scott Gottlieb, M.D., has been confirmed as the new head of the FDA, about four months after his Obama-picked predecessor Robert Califf stepped down.

Gottlieb, a physician, a partner at one of the world’s largest venture capital funds and formerly the deputy commissioner of the FDA (as well as a writer for Forbes), will now take up the reins at the top of the agency and could during his tenure enact some major changes.

One of the key elements he has argued for is the publication of complete response letters, documents issued by the FDA when it has rejected a new medicine for approval.

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Biopharmas will often delay publishing these letters or omit details when they do, and the FDA is not obligated to share the letter with the public. It’s unclear, however, how easily this could be changed, and whether it would require new or amended rules.

He will also serve under the recently enacted Cures Act, which comes with a new package deisgned to help speed up approvals for new drugs and medical devices.

And as President Donald Trump’s pick, he may well too come under pressure to work with his desire to cut back on regulation at the FDA, and cut back on the “burdensome approval process.”

For now, biopharma is happy that the confirmation had been made (and presumably that other, more radical nominees, had not got this far). In a statement, Biotechnology Innovation Organization (BIO) president and CEO Jim Greenwood said: “BIO congratulates Scott Gottlieb on his confirmation as Commissioner of the FDA, a position for which he is eminently qualified and which carries immense responsibility in protecting and promoting the health of all Americans.

“The opportunities facing the agency today are tremendous. We are confident that Gottlieb’s confirmation will provide the agency with the stability and leadership needed to fully harness the tools of modern drug development and to better incorporate patients’ perspectives into the agency’s regulatory processes.

“We look forward to working with Gottlieb to ensure that the FDA has the necessary staff, resources and flexibility required to keep pace with the marvelous advances taking place in the fields of biomedical, agricultural, and animal biotechnology.”

California Life Sciences Association also said it “applauds” his confirmation, with its president and chief Sara Radcliffe adding: “On behalf of the hundreds of life sciences organizations up and down the state we embody, California Life Sciences Association applauds the confirmation of Scott Gottlieb, as FDA Commissioner. Over the span of his distinguished career, Gottlieb has a proven track record as a strong advocate for both protecting public health and promoting biomedical innovation.”

He has, however, been accused by some Democrats as being a little too cozy with biopharma, given that he sits on the board of several small biopharma companies, is an advisor to GlaxoSmithKline and formerly Bristol-Myers Squibb.

Add in his role as a partner at venture capital fund New Enterprise Associates and managing director of investment banking firm TR Winston & Co, and that gives him an interest in a host of small firms. It is not unusual, however, for an FDA commissioner to have former ties to the industry.

And earlier this year, he said he would recuse himself from any decisions on matters in which he has a financial interest, and that includes a lengthy list of biopharma companies.

To do this, he intends to divest interests in 19 companies backed by New Enterprise or TR Winston and other holdings within 90 days of now, and has said he will not carry out any consultancy work whilst in the role.

That involves resigning from consultancy positions at GSK, MedAvante and Glytec—he has already stepped down from roles at Gradalis and Strike Bio—and will also duck out of matters involving “specific parties in which I know a former client of mine is a party or represents a party for a period of one year after I last provided service to that client.”

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