On March 10, the White House announced that President Donald Trump selected Scott Gottlieb, MD, who has worked for FDA in the past, as his choice to head the FDA. Here are five things managed healthcare executives should know about the pick.
On March 10, the White House announced that President Donald Trump selected Scott Gottlieb, MD, who has worked for FDA in the past, as his choice to head the FDA.
Here are five things managed healthcare executives should know about the pick:
1. In addition to working for the FDA, Gottlieb has worked for HHS and has other well-fitted credentials.
“Gottlieb’s science background and prior high-level stints at the FDA, including serving as a deputy commissioner for Medical and Scientific Affairs Policy under President George W. Bush, are good indications that he will be able to guide the FDA in fulfilling its science-based regulatory obligations,” says Todd Harrison, partner and co-chair of the food and drug law practice at Venable LLP. “He also currently sits on the Federal Health IT Policy Committee, which advises the Department of Health and Human Services on healthcare IT issues, so he should have ready insight into how FDA can address these types of issues as it regulates industry.”
Chad Landmon, chair of the FDA and intellectual property practice groups at the law firm Axinn, Veltrop & Harkrider, LLP, notes that since leaving public service, Gottlieb continued his work in the healthcare industry, particularly through his work with the American Enterprise Institute-where he focused on issues involving FDA, and through his position as a clinical assistant professor at the New York University School of Medicine. “Gottleib’s experience in these roles, his continuing role as an advisor to the U.S. Department of Health and Human Services, and his experience as a practicing physician give him a deep understanding of the industry’s concerns,” he says.
2. Gottlieb has long been a consultant for major pharmaceutical companies.
Given his history with pharmaceutical companies, Harrison believes conflicts may arise when Gottlieb is crafting, revising, or implementing policies that directly affect the relationships of companies he has worked with previously at the FDA. “As a partner or principal at venture capitalist and investment firms that have invested in companies in the healthcare space, potential conflicts of interest may be more difficult to ferret out,” he says.
3. Gottlieb has been an outspoken critic of the FDA’s review and approval process, particularly as it concerns new and generic drugs.
Harrison expects Gottlieb to focus on reforming processes to make the FDA more nimble and accepting of certain risks around drug efficacy and, generally, to speed up and perhaps restructure review and approval processes. “He’s on record as supporting the 21st Century Cures Act, which became law in December 2016,” he says. “The act contains several provisions meant to reform FDA’s drug approval processes, so he may be expected to embrace and push for their rapid implementation.”
In the past, Harrison notes that Gottlieb has suggested separating the review and approval processes, so that the latter is done by the agency’s senior scientists. And, in a speech given in early March at the Pharmacy Benefit Management Institute’s Annual Drug Benefit Conference in Orlando, Florida, he criticized the FDA’s oversight of generic drugs, stating that an overhaul is needed because the current processes have allowed brand-name companies to create “monopolies in perpetuity.”
Next: How Gottlieb will approach pharma costs
4. Gottlieb will likely take measures to lower pharmaceutical costs, which Trump has listed as high on his agenda.
Having worked on the implementation of the FDA’s generic drug user fee program, Gottlieb has direct knowledge of how this process was intended to work. “With drug prices as a persistent hot topic, he can be expected to frame his drug review and approval reform wish list as a way to address drug prices and spur competition,” Harrison says. “This kind of reform focus also fits with his support for innovation in the healthcare space.”
Says Landmon, “I think that he will at least work to speed the approval of generic drugs in an effort to lower pharmaceutical prices. This goal is generally supported by both parties in Congress and has wide support in the public.”
5. Due to legislation, it could be difficult for Gottlieb to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements, and tobacco-which Trump has touted.
“Although Gottlieb can certainly take certain administrative actions at the margins to reduce the regulatory burdens on industries regulated by FDA, much of the oversight provided by FDA is governed by statute,” Landmon says. “To enact significant change, Gottlieb and the Trump administration would need to convince Congress to enact legislative changes, which may be difficult in today’s politically heated environment.”
Karen Appold is a medical writer in Lehigh Valley, Pennsylvania.