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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The Senate Health, Education, Labor & Pensions committee on Thursday advanced Dr. Scott Gottlieb’s nomination to lead the US Food and Drug Administration (FDA).
The 14-9 vote, a day after a delay, was largely along party lines (Democrat Sens. Michael Bennet (D-CO) and Sheldon Whitehouse (D-RI) voted aye) and follows a back and forth on Gottlieb’s experience seen in the hearing to consider his nomination.
Prior to the vote, Sen. Lamar Alexander (R-TN) praised Gottlieb’s experience while Sen. Patty Murray (D-WA) criticized Gottlieb’s link to the industry that he would be regulating, though she acknowledged that she was pleased with some of his responses to written questions.
Sen. Orrin Hatch (R-UT) added: “I’ve seen an awful lot of FDA commissioners, I don’t know that any have come here with more qualifications than Dr. Gottlieb. The fact that he has so much experience seems to be a great advantage for our country.”
Sen. Maggie Hassan (D-NH) also said she would vote against, particularly as he expressed opposition to risk evaluation and mitigation strategies (REMS), which are used by FDA to stem certain risks from pharmaceuticals.
The full senate will now vote on his nomination.
Further elucidating Gottlieb’s views on certain subjects, the written comments submitted to the Senate HELP committee may offer a look at where FDA is headed in the future.
According to Endpoints News, he told senators that while ensuring new products continue to meet FDA’s gold standard for safety and efficacy, FDA should also explore options to improve the efficiency and consistency of abbreviated new drug application (ANDA) review processes and timelines so financial speculators “cannot engage in a regulatory arbitrage, by dramatically hiking the price of some very old generic drugs because they know it can take years for new generic competitors to enter the market.”
He also called for publicly releasing complete response letters, which are the rejections sent to drugmakers that often do not disclose the reasons that their products failed to win approval.
Jim Miller, JD, MPH, senior associate in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health, explained to Focus in March that FDA could, without congressional action, change its regulations via a proposed rulemaking to allow for at least portions of CRLs to be released by FDA.
Gottlieb also advocated for incorporating more Patient Reported Outcomes (PROs) as endpoints in clinical trials.
Tags: Gottlieb, Senate FDA, FDA commissioner