Gottlieb FDA nomination praised
Pharmaceutical manufacturers and some consumer groups praised President Donald Trump’s nomination of Scott Gottlieb, MD, as the new FDA commissioner.
If confirmed by the Senate, Gottlieb is expected to significantly cut regulations on drugs and devices, and speed approval for new medicines. He will likely increase flexibility in the clinical trial development process.
"Scott Gottlieb has more experience and success in modernizing the FDA than anyone else nominated for that position in recent history,” Medical Economist Robert Goldberg, PhD, cofounder and vice president of the Center for Medicine in the Public Interest, told FormularyWatch. “His experience as a practicing physician and a cancer survivor also means he brings a unique perspective to the job that others have not possessed.”
Dr Gottlieb, a former acting FDA deputy commissioner, is also on the board of small drug and biotech companies and is an adviser to GlaxoSmithKline. In addition, he is a fellow at the American Enterprise Institute think tank and a partner at a large venture capital fund.
"Thank God it's Gottlieb," Brian Skorney, an investment analyst at Robert W. Baird, wrote in a research note, according to Reuters. "We view this as a favorable development for the sector."
In addition, the Pharmaceutical Research and Manufacturers of America said it "looks forward to working with Dr Gottlieb in his new role and engaging with him and the Agency as they seek to modernize the drug discovery and review process,” a spokesman told Reuters.
However, critics of the nomination say Dr Gottlieb's financial background is rife with conflicts of interest.
Dr Gottlieb "has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry,” Michael Carome, MD, director of Public Citizen's Health Research Group, told Reuters. If confirmed, "he will have to be recused from key decisions time and time again."