Gottlieb Unleashed: Focus on Drug Pricing To Intensify As He Rejoins AEI

Without constraints of being FDA commissioner, Gottlieb will have podium to push for changes to drug pricing and competition.

Drug pricing has been a signature issue for US FDA Commissioner Scott Gottlieb so it's natural he will continue to focus on this at his post-FDA perch.

Gottlieb will be returning to the American Enterprise Institute after he leaves the agency April 5, and the issues he will focus on likely include those that drew his attention as commissioner. In a recent interview with the Pink Sheet, he emphasized his concern about the time it takes second-to-market innovations to reach patients. He said there were policy, regulatory and scientific reasons for this that need to be addressed as a set of challenges. (Also see "Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition " - Pink Sheet, 27 Mar, 2019.)

Gottlieb was a resident fellow at AEI prior to becoming Commissioner in May 2017. During his previous time at the conservative think tank, he was outspoken on drug pricing. One of his proposals had been merging Medicare Part B and Part D coverage programs so plans can negotiate pricing for Part B drugs as they do in Part D, thereby lowing prices and costs for Medicare. (Also see "Drug Pricing Pundit Gottlieb Likely To Stay In His Lane At FDA" - Pink Sheet, 14 Apr, 2017.)

He rejoins AEI with a deeper perspective and a greater ability to influence policy given his experience as commissioner, particularly given his immense popularity and accomplishments at the agency.

Tackling Issues 'More Holistically'

Industry consultants say he has more flexibility to advocate positions outside FDA.

"When running FDA he was precluded from getting into market issues because it's other people's turf," said Avalere Health Founder Dan Mendelson. For example, he said Gottlieb couldn’t tweet that Medicare should take a more active role in biosimilars.

Now, he "can address issues more holistically" without having to worry about FDA constraints, Mendelson said.

Rebecca Davison, director at the health care policy group ADVI Health, said that given how incredibly effective he was at FDA, Gottlieb's opinions will be given even greater attention.

Running the agency has given him a different perspective, she said. "I'm curious whether that will impact how he talks about the government or creates new policy."

FDA Track Record

Gottlieb worked at AEI following his previous government stints. He served as senior advisor to FDA Commissioner Mark McClellan from 2003-2004 and became director of medical policy development before moving to the Center for Medicare and Medicaid Services as a senior advisor. He returned to FDA in 2005 as deputy commissioner for medical and scientific affairs for a year-and-a-half.

Prior to becoming commissioner, he also served as a venture partner at New Enterprise Associates and served on the boards of several pharmaceutical companies. He also was clinical assistant professor at New York University School of Medicine.

Gottlieb returns to the policy arena after changing the landscape at FDA. He put the agency at the forefront of the drug pricing debate. In his first speech to staff he said that even though FDA cannot set prices, it can promote competition and he made that one of the priorities of his tenure.

He sought to eliminate roadblocks to competition, including brand name company efforts to deter generic entry by refusing to turn over product samples for testing. He also oversaw release of FDA's Drug Competition Action Plan and Biosimilar Innovation Plan, which were included in FDA's 20118 Strategic Policy Roadmap.

Gottlieb also advocated positions outside FDA's realm. He criticized the complicated system of rebating and contracting employed by pharmacy benefit managers  (Also see "Biosimilars Need Better Reimbursement, Not 'Kabuki' Coverage, Gottlieb Tells Insurers" - Pink Sheet, 7 Mar, 2018.) and praised announcements by health insurers to get rebates into the hands of patients at the point-of-sale. (Also see "FDA's Gottlieb Applauds Drug Rebates At Point-Of-Sale" - Pink Sheet, 28 Mar, 2018.) And he told insurers they need to take a more proactive role in fostering the early biosimilar market. (Also see "Biosimilars Need Better Reimbursement, Not 'Kabuki' Coverage, Gottlieb Tells Insurers" - Pink Sheet, 7 Mar, 2018.)