Trump Picks Scott Gottlieb As Next FDA Commissioner

By Jof Enriquez,
Follow me on Twitter @jofenriq

President Donald Trump will nominate Scott Gottlieb, a physician and former official at the Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS), as the next FDA commissioner, replacing Robert Califf.

Gottlieb, 44, served as chief policy adviser to the CMS administrator in 2004, and as FDA deputy commissioner for medical and scientific affairs under President George W. Bush, from 2005 to 2007. Earlier, he was a senior adviser and director of medical policy development at FDA, where he tackled issues like orphan drugs and combination products, according to Politico.

Since leaving FDA, he has worked either as a board member or adviser to at least nine pharmaceutical or medical technology companies, and currently is a resident fellow at the conservative American Enterprise Institute, and a partner in the venture capital firm New Enterprise. He also serves as a policy adviser to the National Coalition for Cancer Survivorship.

A long-time advocate for deregulation and free-market health policy, Gottlieb will spearhead Trump's reform agenda for FDA, whose approval process Trump had criticized as “slow and burdensome,” despite the agency instituting measures to streamline regulation in recent years. Gottlieb has said that he is in favor of cutting red tape, which hinders competition.

Gottlieb is considered a more traditional and suitable choice to head FDA, compared to Silicon Valley insiders Jim O'Neill and Balaji Srinivasan, who also were considered for the post.

“Scott is an exceptional choice for FDA commissioner,” Paul Howard, a senior fellow with the conservative Manhattan Institute, told STAT. “He has led investments in new medicines and in new approaches in therapeutics. It’s extraordinarily helpful for someone who is leading the agency at a time of tremendous technological change to have that kind of vision and experience.”

But critics have stated Gottlieb's close ties to the drug and medtech industries may constitute conflict of interest.

Rep. Rosa DeLauro, D-Conn., who serves on the House Appropriations subcommittee that oversees FDA funding, said Gottlieb's nomination sends the message that Trump is committed to "rolling back regulations and opening the floodgates to potentially dangerous drugs and medical devices," reports AP.

Concerns regarding Gottlieb's fit and impartiality probably will come up at his Senate confirmation hearing, which could delay his confirmation, similar to what happened with his predecessor, Califf.

On the other hand, Gottlieb's medical background and experience at FDA and CMS could bode well for FDA and industry.

"His 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. Our industry applauds Dr. Gottlieb’s commitment to innovation in medical technology and his recognition of its important role in providing the best care possible for patients," AdvaMed said in a statement. “Specifically, we look forward to working with Dr. Gottlieb and his team on the medical device user fee reauthorization in the coming weeks and months in our mutual pledge to continued patient access to life-changing technologies.”

Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), stated that Gottlieb “has dedicated his career to helping patients, and has shaped policies that improve access to lifesaving and life changing treatments… While the United States remains the global leader in medical technology innovation, there is still much more work to be done.”