Outrage of the Month: Revolving Door to FDA Commissioner’s Office Sows Distrust in Agency

Health Letter, October 2019

By Michael Carome, M.D.

outrage

If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

FDA revolving door
Image: By TheBlackRhino/Shutterstock.com

Before being appointed the 23rd Commissioner of the Food and Drug Administration (FDA) in May 2017, Dr. Scott Gottlieb was entangled in an unprecedented web of close ties to Big Pharma. And less than three months after his April 5, 2019, departure from the agency, Gottlieb firmly reestablished his financial links to the pharmaceutical industry when Pfizer — one of the world’s largest drug companies with more than $53 billion in revenue in 2018 — on June 27 announced his appointment to the company’s board of directors. A seat on the Pfizer board is quite lucrative, having paid more than $330,000 in cash and company stock in 2018.

Such a rapid swing through the revolving door between the FDA Commissioner’s office and the pharmaceutical industry inevitably erodes public trust in one of the leading agencies of the Public Health Service. The public rightly wonders whether the actions of Gottlieb — and of the FDA under his leadership — always best served the public health interests of the American people rather than the interests of Big Pharma and his own personal financial interests.

Public Citizen strongly opposed Gottlieb’s nomination to be FDA Commissioner because of his deeply rooted ties to Big Pharma that spanned more than a decade. From 2007 to 2017, he had been a venture partner at New Enterprise Associates, which proclaims to be “one of the world’s largest and most active venture capital firms,” with investments in biopharmaceuticals and medical devices.

At the time of his 2017 nomination, Gottlieb also was serving or had recently served on several drug company boards, including the Product Investment Board of GlaxoSmithKline — another of the world’s largest drugmakers. According to a federal database that tracks industry payments to physicians, from August 2013 through December 2016, Gottlieb received a total of $559,000 from multiple drug and medical device companies — including AstraZeneca, Pfizer and Bristol-Myers Squibb — mostly for consulting and speaking fees.

The cloud of justifiable public distrust created by Gottlieb’s rapid appointment to Pfizer’s board of directors was reflected in a July 3 story in the Milwaukee Journal Sentinel (MJS) that reported that the FDA under Gottlieb, just weeks before his resignation as FDA Commissioner, took less aggressive regulatory actions than European regulators in response to safety concerns about Pfizer’s drug tofacitinib (Xeljanz). Commenting on the FDA’s limited action on tofacitinib and Gottlieb’s subsequent appointment to the Pfizer board, University of Minnesota bioethicist Dr. Carl Elliot told the MJS that “It sounds like a reward for a job well done.”

Placing the brakes on the dangerous, rapidly revolving door between federal regulatory agencies like the FDA and regulated industries will require action by Congress, but don’t hold your breath.