New FDA Chief Scott Gottlieb: Medication Reformer or Big Pharma Shill?

By Paul Gaita 05/18/17

Gottlieb's connections to Big Pharma have left critics wondering if he can be trusted to act in the interest of the American people.

Dr. Scott Gottlieb
Dr. Scott Gottlieb Photo via YouTube

Dr. Scott Gottlieb, who was sworn in as the new commissioner at the Food and Drug Administration (FDA) on May 11, has placed the fight against opioid addiction in America as the top priority during his tenure.

He also wants to bring down the cost of prescription drugs in a way that runs opposite of President Donald J. Trump's proposal, which he has described as "aged." But the question is not so much whether Gottlieb can enact any significant change, but whether he can be trusted to act in the interest of the American people, and not the pharmaceutical industry, with which he has significant ties.

Gottlieb, who previously served as FDA deputy commissioner under President George W. Bush, has described the opioid epidemic as "a public health emergency on the order of Ebola and Zika." His advocacy of reforming the Critical Path Initiative, the process by which medication is tested and approved for use, has earned him the support of cancer research groups, who point to his own successful fight against Hodgkin's lymphoma as proof of his forward thinking in making new drugs available to patients.

He's also earned headlines for criticizing Trump's plan to cut prescription drugs by importing them from countries such as Canada that impose price controls. In 2016, Gottlieb described the plan as "[offering] consumers little relief." 

Gottlieb's position has earned cautious approval from medical industry observers like Washington University associate professor Rachel Sachs, who wrote, "As someone who understands the drug development process from all sides, [Gottlieb] will be more informed. I'm going to wait to judge to see what policy decisions he comes to. Hopefully, he has the agency's best interest at heart." More significantly, the pharmaceutical industry has applauded his appointment, "We look forward to working with Dr. Gottlieb in his new role," said Stephen J. Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America.

But Gottlieb has also answered to, and earned an income, from positions on the board of directors for numerous pharmaceutical companies, including American Pathology Partners, Aptiv Solutions, and MedAvante. He's also served as an independent advisor to Vertex Pharmaceuticals, a venture partner at New Enterprise Associates, which handles numerous health care investments, and a member of GlaxoSmithKline's Product Investment Board. According to his ethics disclosure, Gottlieb has no financial interest in New Enterprise, but has financial ties to 19 of their client companies, which produce a host of drugs for various diseases.

According to the Wall Street Journal, Gottlieb made approximately $3 million in speaking, consulting and retainer fees from various medical entities from January 2016 through March 1, 2017. He has stated that he will resign within 90 days from any board, and will divest himself of medical company stocks and recuse himself for a year from making decisions for companies like GlaxoSmithKline.

Former FDA commissioner Dr. Robert Califf also drew criticism during his tenure for his ties to the industry, but Harvard University government professor Daniel Carpenter noted that there is a significant difference in their levels of involvement. "There is a huge difference between research work with these companies and being a consultant sitting on a board," he noted. "There, you are making decisions about corporate management. You're not doing the science."

Ultimately, Gottlieb's intimate connection with the industry places him in a dangerous position, both for his own agency and for the health care industry. "The worry here is that you're damned if you do and damned if you don't," said Carpenter. "If he's constantly recusing himself, he can't function as commissioner, because he's taking himself out of a wide variety of decisions. But if he doesn't, then we should worry even more about conflicts of interest."

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, and The Los Angeles Beat, among many other publications and websites.