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Scott Gottlieb trumps competition as FDA Commissioner nominee

Monday, March 20, 2017

President Trump’s choice of Scott Gottlieb, M.D., a conservative health policy expert and venture capitalist, to lead the FDA has drawn wide support from the drug industry, yet the nominee may face scrutiny on Capitol Hill over potential conflicts of interest.

Gottlieb, a medical doctor and former FDA deputy commissioner, serves on the board of several biopharmaceutical companies and has received more than $400,000 in payments from drugmakers in the last few years.

Gottlieb has frequently criticized the FDA for regulations that slow innovation and patient access to new drugs, yet he is not expected to dismantle the agency. He is widely seen as a less radical choice than another rumored candidate, venture capitalist and libertarian Jim O’Neill, who generated widespread concern among industry executives when he argued for an FDA approval process that allowed drugs on the market once they were proven safe, but were not yet shown to be effective.

“We believe Dr. Gottlieb will strike the appropriate balance of encouraging innovation while ensuring the safety and efficacy of new drugs,” said Doug Peddicord, Ph.D., executive director of the Association for Clinical Research Organizations (ACRO), a trade association that represents the industry on legislative and regulatory matters.

The industry has closely watched for the Trump administration’s announcement of its FDA nomination during the past few months. Trump’s promise to cut FDA regulations by at least 75% and criticism of the “slow and burdensome” drug approval process raised fears that the new commissioner could lead a major overhaul of the agency that would result in a less rigorous FDA review process, which could put patients at risk and make it harder to convince physicians and insurance companies that new treatments deliver value.

Of the candidates under consideration by the Trump administration, Gottlieb was clearly the industry favorite to head the FDA. A widely quoted survey conducted by investment bank Mizuho Securities USA found that 72% of executives from 53 pharmaceutical companies surveyed favored Gottlieb over other potential nominees. Many respondents named Gottlieb as the best choice for both the agency and the industry as the White House pushes for faster drug approvals and cuts in regulations.

Several industry groups, including the Pharmaceutical Research and Manufacturers of America (PhRMA), the Advanced Medical Technology Association (AdvaMed), the Alliance for Regenerative Medicine (ARM) and ACRO have praised the selection of Gottlieb.

“His extensive experience as a physician and breath of healthcare knowledge will help ensure that the FDA continues to play a vital role in protecting public health and innovation in the agency’s review and approval of new medicines for patients in need,” said Stephen J. Ubl, president and chief executive officer of PhRMA, the drug industry’s largest trade group and lobbying arm. “We look forward to working with Dr. Gottlieb in his new role and engaging with him and the agency as they seek to modernize the drug discovery and review process and advance competition in the biopharmaceutical market.”

Gottlieb’s nomination, however, has faced criticism from consumer advocates who are concerned that his financial background and close relationship with the drug industry could harm the agency’s commitment to safety and efficacy during the drug approval process.

Gottlieb holds positions with two venture capital firms, serving as a partner with New Enterprise Associates, which has investments in healthcare and technology, and as a managing director at T.R. Winston & Company, an investment banking firm that focuses on healthcare. According to his LinkedIn profile, Gottlieb also has served as a board member or advisor for at least nine pharmaceutical or medical technology companies since leaving the FDA in 2007. He currently is a member of the product investment board for GlaxoSmithKline and a member of the board of directors for MedAvante and Glytec. According to the federal Open Payments database, Gottlieb received more than $400,000 in general payments from drug companies between 2013 and 2015 while practicing at Stamford Hospital in Connecticut.

“President Trump’s FDA pick, Scott Gottlieb, is entangled in an unprecedented web of Big Pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry. The U.S. Senate must reject him,” said Michael Carome, M.D., director of Public Citizen’s Health Research Group. “Gottlieb’s appointment would accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with interests of industry than those of patients.”

Nevertheless, some patient groups have voiced support for the nomination. In public statements, Gottlieb has criticized the speed of the FDA drug approval process and said the agency sometimes focuses on trial design or statistical requirements over the needs of patients. If confirmed, one of his priorities will likely include simplifying the approval process for generic versions of complex therapeutics.

“We deeply respect Dr. Gottlieb and have worked closely with him throughout his tenure at the FDA and in his various leadership roles in health policy,” said Ellen Sigal, founder and chairman of Friends of Cancer Research. “Focusing on patients is vital and we know that Dr. Gottlieb will continue to direct the agency to be patient-centric and science-driven.”

Gottlieb is considered a more traditional choice to lead the FDA than other candidates on Trump’s reported shortlist. He served as FDA deputy commissioner for medical and scientific affairs for two years under former president George W. Bush and as a senior official at the Centers for Medicare and Medicaid Services. For the past 14 years, he has been a resident fellow at the American Enterprise Institute, a conservative think tank, where his research focused on various aspects of federal healthcare policies. 

Once confirmed, a top priority for the new commissioner will include implementing the provisions of the 21st Century Cures Act, which could vastly change the regulatory system for drugs and medical devices, and to address reauthorization of the medical device user-fee program. 

 

This article was reprinted from Volume 21, Issue 11, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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