Trump nominee slated to cut red tape, speed drug approvals
Gottlieb, nominated as FDA commissioner by President Donald Trump in March, took the helm as the FDA’s 23rd commissioner on Thursday after being confirmed by a vote of 57-42 in the Senate late Tuesday.
He takes over from Dr. Robert Califf, a President Obama appointee who was confirmed by the Senate in February 2016 and stepped down from the post on Jan. 20. Stephen Ostroff, commissioner for food and veterinary medicine, had been serving as acting FDA commissioner — his second stint in that role, having held it following the resignation of Margaret Hamburg, which led to the appointment of Califf.
“Under Dr. Gottlieb’s leadership, the FDA can capitalize on the significant funding Congress has given to medical research and make sure that patients benefit from last year’s 21st Century Cures Act, which Majority Leader [Mitch] McConnell called ‘the most important legislation of the year,’ ” stated Lamar Alexander (R., Tenn.), chairman of the Senate Health, Education, Labor & Pensions Committee (HELP).
Alexander chaired Gottlieb’s confirmation hearing on April 5, and the HELP committee met on April 27 to approve his nomination.
“I look forward to working with Dr. Gottlieb on a successful implementation of the Cures law to help virtually every American live a healthier life, and on a prompt reauthorization of the medical product user fee agreements before the August recess,” Alexander added. “Dr. Gottlieb is the right pick to lead the FDA, and we are fortunate he is willing to serve.”
A physician, medical policy expert and public health advocate, Gottlieb previously served as the FDA’s deputy commissioner for medical and scientific affairs and, before that, as a senior adviser to the FDA commissioner. He also worked on implementation of the Medicare drug benefit as a senior adviser to the administrator of the Centers for Medicare & Medicaid Services. In 2013, the Senate appointed Gottlieb to serve on the Federal Health Information Technology Policy Committee, which advises the U.S. Department of Health and Human Services (HHS) on health care information technology.
In addition, Gottlieb was previously a resident fellow at the American Enterprise Institute and a clinical assistant professor at the New York University School of Medicine in Manhattan, where he also practiced medicine as a hospital physician.
President Trump made pharmaceuticals a focus area early in his administration, saying he aimed to bring down escalating drug prices and unfurl regulatory snags to expedite approvals of new medications. Gottlieb will be charged with helping to cut red tape to get new drugs to market faster.
“Dr. Gottlieb brings considerable experience to the FDA,” commented HHS Secretary Tom Price. “His background will be crucial for keeping the FDA as the gold standard for safe treatments while advancing new, innovative solutions to the many public health challenges our nation faces. I am confident Dr. Gottlieb will make decisions that reduce regulatory burdens while protecting public health.”
Gottlieb is “eminently qualified” for the post of FDA commissioner, “which carries immense responsibility in protecting and promoting the health of all Americans,” according to Jim Greenwood, president and chief executive officer of the Biotechnology Innovation Organization (BIO).
“The opportunities facing the agency today are tremendous. We are confident that Dr. Gottlieb’s confirmation will provide the agency with the stability and leadership needed to fully harness the tools of modern drug development and to better incorporate patients’ perspectives into the agency’s regulatory processes,” Greenwood stated. “We look forward to working with Dr. Gottlieb to ensure that the FDA has the necessary staff, resources and flexibility required to keep pace with the marvelous advances taking place in the fields of biomedical, agricultural, and animal biotechnology.”