Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 08 March 2017 | By Zachary Brennan
Dr. Tom Price, secretary of the US Department of Health and Human Services, said in an interview this week that the new commissioner for the US Food and Drug Administration (FDA) and other health-related political appointees should be announced in the next week or so.
Price, speaking on the Hugh Hewitt show on Monday, said: “I’ve got 18 Senate-approved, presidential-appointed, Senate-approved folks in my department, and we’ve got virtually all of them with names that we have sent to the White House. Most of them are, well, they’re all in various stages of being vetted and reviewed. Some, you know, they’ve got to go through an FBI background check and the whole financial vetting process that occurs. And so that’s where most of them are, and I think you’ll see some names being announced, I hope, this week, if not next.”
Dr. Scott Gottlieb, a resident fellow at the conservative American Enterprise Institute and former deputy commissioner at FDA, remains the front runner as the next FDA commissioner.
Gottlieb, who would need to win Senate confirmation, declined to comment on the process or the timing of the announcement, though some have speculated what his early focus at the agency might be. There may still be an outside chance of a Peter Thiel associate, like Jim O’Neill or Balaji Srinivasan, winning the nomination, though both they, Joseph Gulfo and any others remain longshots, according to conversations with industry and FDA insiders.
“It takes a leader [at FDA],” Price told Hewitt. “And I think that folks will be very, very pleased with the individual that we’ve identified and will hopefully work and get through the Senate confirmation process. It takes a leader who understands and respects the fact that getting, having a medication or a device come to market and having it take 10 to 14 years is simply too long.”
How Trump, Price and the new FDA commissioner look to shift particular FDA policies remain to be seen, though all of the recent talking points have focused on a lessening of FDA regulations to speed new treatments and medical devices to patients faster, though as many experts have noted, the US leads all other countries in bringing new treatments to market, and laws would have to be altered by Congress for the drug and device approval bar to come down.
Trump also may take a more unorthodox approach to bringing down the cost of US drugs as he met Wednesday with Democratic representatives to discuss possibly allowing the Centers of Medicare and Medicaid Services to negotiate further with pharmaceutical companies or allowing imports from abroad.
Tags: FDA commissioner, Scott Gottlieb, Tom Price