The Senate today confirmed Scott Gottlieb, MD, as FDA commissioner by a margin of 57 to 42 votes. The vote came along party lines, with Democratic Senators criticizing Gottlieb’s intertwined connections with the pharmaceutical industry and his opposition to FDA’s risk evaluation and mitigation strategies.
Gottlieb’s predecessor, Robert Califf, MD, who led the FDA for less than a year, has previously expressed his faith in Gottlieb as the FDA head.
Welcoming Gottlieb’s nomination, Rep. Greg Walden (R-OR.), chairman of the House Energy and Commerce Committee, and Rep. Michael C. Burgess (R-TX), said in a statement, ““We are at a critical juncture in the effort to help accelerate the discovery, development, and delivery of new cures and treatments, and Scott will be an important ally in that journey.”
An important task for the incoming leader of the FDA is to meet the Trump administrations goals of speeding up the drug approval process and also to implement the provisions of the 21st Century Cures Act. The challenges would be to bring about these changes on a very tight budget.
Meanwhile, several organizations, including the American Society of Clinical Oncology (ASCO) and the American College of Rheumatology (ACR) have expressed their support for Gottlieb’s confirmation.
“As a physician and cancer survivor, Dr Gottlieb knows firsthand that safe and effective cancer treatments must move from the lab to the patient as quickly as possible. We are hopeful that Dr Gottlieb will serve as a passionate advocate for the public’s health,” said Daniel F. Hayes, MD, FACP, FASCO, president of ASCO, in a statement.
In his statement congratulating Gottlieb, Sharad Lakhanpal, MBBS, MD, president of ACR said, “The FDA continues to play a critical role in lowering biologic drug costs as it works to bring safe, effective, and lower-cost biosimilar alternatives to the marketplace. Therefore, it is imperative that FDA have the funding and resources it needs to expedite biosimilar drug approvals, hire and retain qualified staff, issue guidance, and perform adequate post-market surveillance.
“We look forward to working with Commissioner Gottlieb, Congressional leaders and the Trump Administration to bolster the FDA’s important work on biosimilars to ensure more Americans can access safe, effective and life-changing therapies.”