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There’s a common path among former FDA commissioners.
THE CIRCLE OF REGULATION

Trust issues deepen as yet another FDA commissioner joins the pharmaceutical industry

Katherine Ellen Foley
By Katherine Ellen Foley

Health and science reporter

Pharma-giant Pfizer announced on June 28 that the former US Food and Drug Administration commissioner Scott Gottlieb would be joining its board of directors. The move fell in line with a troubling pattern: After their tenure at the FDA, commissioners tend to go on to advise private companies in the pharmaceutical industry.

In fact, 9 out of the last 10 FDA commissioners—representing nearly four decades of agency leadership—have gone on to work for pharmaceutical companies. The lone exception, David Kessler, joined the ranks in academia before eventually settling in his current position as chair of the board of directors at the Center for Science in the Public Interest, a non-profit nutritional science advocacy group.

Commissioner nameYears as FDA CommissionerFirst pharmaceutical venture and positionYear
Arthur Hayes1981-1983E. M. Pharmaceuticals, president1986
Frank Young1984-1989Braeburn Pharmaceuticals, executive vice president2013
David Kessler1990-1997None1997
Jane Henney1999-2001AmerisourceBergen Corp, member of board2002
Mark McClellan2002-2004Johnson and Johnson, member of board2006
Lester Crawford2005-2005Bexion Pharmaceuticals, member of board2011
Andrew von Eschenbach2006-2009Bausch Health, member of board2018
Margaret Hamburg2009-2015Alnylam Pharmaceuticals, director2018
Robert Califf2016-2017Verily, advisor2017
Scott Gottlieb2017-2019Pfizer, member of board2019

On its own, Gottlieb’s move from FDA commissioner to Pfizer board member isn’t necessarily a problem for the FDA. There’s nothing illegal about the move, Kessler told Quartz in an interview.

However, when it happens again and again—as it has for the past 38 years—it raises the specter of conflict of interest. The perception of a so-called “revolving door”—a chummy agreement between big drug companies and the regulators who approve their products for sale—undermines trust in the FDA.

“[The American people]believe that the FDA is making their decisions in their interest and no one else’s,” Kessler told Quartz.

In addition to the issues arising from the agency’s pharmaceutical ties, Kessler said he also worries about the FDA’s politicization, which could be viewed as a threat to its ability to base decisions on independent, scientific analysis.

The FDA is a branch of the Department of Health and Human Services, and commissioners are appointed by the president of the United States. President Donald Trump appointed Gottlieb in 2017. He also served as a deputy commissioner to the FDA under former President and fellow Republican George W. Bush. Kessler and six of his former commissioner colleagues—Frank Young, Margaret Hamburg, Andrew von Eschenback, Mark McClellan, Jane Henney, and Robert Califf—have called (pdf) for more autonomy at the FDA. They say the FDA should be a completely independent government organization, free from the ever-shifting politics tied to the presidency.

In response to accusations of conflict of interest, Gottlieb said he always put public health first.

“I’m confident my record at FDA demonstrates I put the public health interest first and called balls and strikes based on the science and the public interest,” Gottlieb told STAT news in an email.

But during his tenure at the FDA,  one of Gottlieb’s main initiatives was to speed up the approvals of biosimilars, which are equivalent to the generic form of biologic drugs that treat autoimmune conditions and certain types of cancers. In an eyebrow-raising coincidence, Pfizer—Gottlieb’s new professional home—now manufactures four kinds of biosimilars that aim to compete with some of the most popular biologic drugs on the market today.

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