Trump’s FDA choice Gottlieb offers solution to conflict-of-interest claims

In a letter to the ethics head of the Department of Health and Human Services, Gottlieb — who is President Trump’s preferred choice for the role—has said he will recuse himself from any decisions on matters in which he has a financial interest, and that includes a lengthy list of biopharma companies.

As a former FDA Deputy Commissioner and health policy expert, Gottlieb has the credentials for the job.  However, 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.

Those links have made some people particularly uncomfortable, particularly in light of a just-published Wall Street Journal article that says Gottlieb earned millions of dollars from his industry-related activities in the last few years.

Public Citizen recently blasted Gottlieb for his links to industry and “dangerous deregulatory approaches”, while Harvard professor and FDA historian Daniel Carpenter has said he would be the “most interest-conflicted commissioner in American history.”

Lawmakers have also expressed their reservations, with Senator Patty Murray (D-WA) — ranking member in the Health, Education, Labor and Pensions (HELP) committee — pledging to “closely review Dr. Gottlieb’s long career in the health sector, including his work with multiple pharmaceutical companies, medical device companies and investment firms, to determine whether financial entanglements or conflicts of interest could impact his decision-making.”

Gottlieb has spelled out his plans to sidestep the issue in his letter to DHHS associate general counsel for ethics Elizabeth Fischmann.  He intends to divest interests in 19 companies backed by New Enterprise or TR Winston as well as other holdings within 90 days of being confirmed FDA Commissioner, and says he will not carry out any consultancy work whilst in the role.

That will involve resigning from consultancy positions at GSK, MedAvante and Glytec—Gottlieb says 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.”

It remains to be seen whether this wholesale severing of industry ties will satisfy the lawmakers tasked with accepting his nomination, and the WSJ points out that some critics are still wary of his willingness to push for a lighter touch on FDA regulation.

In particular, Gottlieb has said that the fast, flexible approach to evidence taken by FDA’s cancer division could be applied more widely across the Agency; however, that is a much milder form of FDA reform than has been proposed by some other candidates for the Commissioner role.

Expect further debate on the issue in the build-up to and during the HELP committee’s hearing on Gottlieb’s nomination, which is scheduled to take place on April 5.

REFERENCE:  Fierce Biotech; 30 MAR 2017; Phil Taylor

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