New Administration = New FDA? Not So much
(Thursday, January 21, 2021)
With a new administration comes a general perception that it will bring major changes at the FDA. But new administrations do not affect most of the operations of the FDA, at least not immediately, and certainly not for most of the regulated industry. The most visible changes are at the administrative levels with a new FDA commissioner, HHS Secretary, and other related political appointees. And these officials do bring their work styles and personalities to the job. Some have been quite vocal and visible, while others relatively low-key. Most work closely with the administration to publicize FDA’s work. FDA is highly structured and most of its day-to-day functions do not see any visible impact of the new administration. There is no impact on the application submission process, meetings with the Agency reviewers, the review timelines, or any other routine tasks for the regulated industry with the change in the administration. The last administration will be known for politicizing FDA in a way that undermined the FDA Commissioner, and generally created an impression that the review staff could be influenced to make decisions, particularly in an emergency. But it was also obvious that despite the pressures, FDA’s decisions did not seem to be overtly influenced by the politics but stayed driven by data and on timelines defined by the FDA. One would hope that the current administration to go back to the time-honored practice of not disturbing the balance between regulators and the industry which has benefit the consumers for decades. Being a science- and data-driven organization has kept FDA as the leader for regulators worldwide, and that is not about to change. FDA’s job is only to assure healthcare products are safe and effective. FDA is not involved in distribution, pricing, and providing those products of the population; that is the job of the administration. And that is the way it should be.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: [email protected]
​ Linkedin: Mukesh Kumar, PhD, RAC
 Instagram: mukeshkumarrac 
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