After a search that reportedly included a number of twists and turns, President Donald Trump has nominated Dr. Scott Gottlieb to be the next U.S. Food and Drug Administration (FDA) Commissioner.
Gottlieb, a cancer survivor, is clinical assistant professor at New York University and health information technology adviser for the U.S. Department of Health and Human Services, of which the FDA is an agency. He was also the FDA’s deputy commissioner for medical and scientific affairs under President George W. Bush.
Industry reacted favorably to the prospect of a Gottlieb-led FDA.
“Dr. Gottlieb’s deep and diverse journey to better understand the regulatory framework [and the] market forces affecting funding and pricing of new therapeutics, [his] scientific integrity, and most importantly, his views to ultimately serve patients in ways to better engage the individual in their own health are all key attributes for a progressive FDA Commissioner,” said Jennifer Byrne, chief executive officer of PMG Research, Inc. (PMG). “Additionally, the fact that Dr. Gottlieb, himself, is a cancer survivor brings a pragmatic experience that, I suspect, will be a guidepost.”
FDA officials will be at the ACRP 2017 Meeting & Expo in Seattle, WA, next month to take your questions during an exclusive ‘FDA Office Hours’ forum, while presenting several educational sessions designed to provide you with clarity on agency expectations related to CDER BIMO compliance and enforcement, electronic records, eSource Data, eConsent, and more. View Program and Schedule
A number of industry leaders cited Dr. Gottlieb’s broad and somewhat unique experience in a variety of arenas.
“A person with such high-level experience on both sides of the regulatory fence is rare, and potentially sets the foundation for both maximizing public health protections as well as assuring an environment ripe for more streamlined and cost-effective medical progress,” said an industry executive who asked to remain anonymous. “He’s in a great position to personally know the impact of what he would add, keep, and/or take away in this new leadership position.”
“We believe Dr. Gottlieb’s experience working with the agency, industry, and patient advocacy groups provides him with a valuable, unique perspective on the challenges facing clinical research,” said Jim Kremidas, executive director of the Association of Clinical Research Professionals. “We are encouraged by his public support of the 21st Century Cures Act, as well as initiatives to improve efficiencies in delivering new treatments and therapies to patients while ensuring clinical trials are conducted ethically and responsibly.”
“ACRO applauds the thoughtful nomination of Dr. Gottlieb as FDA Commissioner,” added Doug Peddicord, PhD, executive director of the Association of Clinical Research Organizations (ACRO). “We believe Dr. Gottlieb will strike the appropriate balance of encouraging innovation while ensuring the safety and efficacy of new drugs. We look forward to working with him and his team, especially on implementation of the 21st Century Cures Act, where ACRO’s members have particular interest and expertise in areas such as real-world evidence, patient-focused drug development, and innovative clinical trial designs.”
Author: Michael Causey