Scott Gottlieb was FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007. | AP Photo Trump taps Gottlieb for FDA commissioner

President Donald Trump on Friday nominated Scott Gottlieb, a conservative drug industry insider and former FDA and CMS official, to serve as FDA commissioner.

Gottlieb, a physician, is a far more traditional pick to lead the FDA than other candidates Trump had considered. One of them, Silicon Valley investor Jim O’Neill, had shocked public health advocates with his comments that FDA should approve drugs without proof they worked.


If confirmed, Gottlieb would play a major role in the Trump’s administration’s efforts to speed up regulatory approval of drugs. Trump, who’s been critical of high drug prices, has often argued that shortening the FDA approval process and cutting regulations would bring down drug prices.

Gottlieb’s close ties with industry are likely to draw close Senate scrutiny. A classic Washington insider who has occupied conservative turf in the health care debate for two decades, Gottlieb is a board member or adviser to various drug companies and plays a role in funding the industry through a venture capital firm, New Enterprise Associates.

Rep. Rosa DeLauro (D-Conn.), ranking member of the House Appropriations subcommittee that oversees FDA, said Trump's decision "sends a dangerous message that he is committed to rolling back regulations and opening the floodgates to potentially dangerous drugs and medical devices."

FDA, which reviews and approves drugs, vaccines and medical devices, as well as regulates tobacco, food and cosmetics, has a yearly budget of $5 billion, close to 15,000 employees. A slew of FDA user fee programs, in which industry essentially funds half the FDA budget, are up for reauthorization in the fall; it will fall upon Gottlieb, if approved, to shepherd the agreements — negotiated under his predecessor — through Congress.

When it comes to drug prices, Gottlieb has historically favored industry-friendly policies that don’t align with Trump’s most prominent ideas. Gottlieb has opposed negotiations in Medicare’s prescription drug program, a policy traditionally supported by Democrats that Trump has embraced. Though negotiations wouldn’t fall under FDA authority, Gottlieb would be yet another top administration health care official who's opposed drug negotiations, along with HHS Secretary Tom Price. Gottlieb also opposes drug importation, another idea Trump has supported as a way to lower costs.

However, some of Gottlieb’s other ideas on pricing wouldn’t be as well received by pharma and other industry groups. He’s suggested changing the way Medicare pays for costly physician-administered drugs to try to bring down prices through private-sector bidding. He’s also been in favor of more transparency around drug pricing and ending the current system in which drug companies set high list prices but then give rebates to payers.

Drug makers applauded Gottlieb's nomination. "His extensive experience as a physician and breadth of health care knowledge will help ensure 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," PhRMA chief executive Stephen Ubl said in a statement.

The medical-device lobby AdvaMed said Gottlieb's "medical credentials combined with years of service in leadership roles at both CMS and FDA make him a strong choice to lead this key agency."

Gottlieb has broad experience in regulating health care and working for the industry. He received nearly $200,000 in payments in 2015 from eight pharmaceutical companies, according to a federal database tracking drug industry payments. All were classified as “general” payments, meaning they were for things like travel and lodging, consulting or speaking fees. In 2014, he received more than $160,000 in general payments from companies.

Gottlieb has been on GlaxoSmithKline’s research and development board since 2010, according to his resume, and previously was on its oncology board. He advises Bristol Meyers Squibb on its cancer drugs and Cell Biotherapy, an oncology start up. Gottlieb was a senior adviser to Vertex Pharmaceuticals, maker of expensive cystic fibrosis drugs, from 2009 through 2016.

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He holds seats on the boards of drug companies Daiichi Sankyo and Tolero Pharmaceuticals; medical lab company American Pathology Partners; MedAvante, a contract research organization, and Glytech, which makes an FDA-approved insulin dosing support system. He has also served on the board of insurance and medical diagnostic companies.

Gottlieb was FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007, and chief policy adviser to the CMS administrator in 2004, during implementation of Medicare Part D. Earlier he was a senior adviser and director of medical policy development at FDA, where he worked on issues like orphan drugs, and combination products.

Gottlieb has long been a resident fellow at the right-leaning American Enterprise Institute. He serves on the Federal Health IT Policy Committee, which makes recommendations to HHS’s Office for Healthcare Information Technology. He practices medicine at New York University where he is a clinical assistant professor.

Gottlieb's free-market health policy positions are well known thanks to regular op-eds in the Wall Street Journal and Forbes, and FDA-related testimony to Congress. This fall he gave testimony criticizing FDA’s regulation of generic drugs, during a hearing on pharmaceutical industry competition occasioned by the rising prices of the EpiPen.

