Impact of Last Minute Rules for FDA and HHS by Trump Administration 
(Thursday, January 14, 2021]​
Last few weeks, the outgoing administration has been releasing several rules and policies governing FDA and HHS operations worrying industry and other stakeholders about their lasting impact. However, in most cases, it can be easily reversed by the incoming administration, as shown by the outgoing administration 4 years ago. The Presidential election is not the end of an administration, but the beginning of the end. The outgoing administration has about 10-11 weeks before the new administration is sworn in and can create policies and rules that they believe the new administration may not be keen on. It could take the new administration a few weeks to review, and, if needed, reverse any policy or guideline from by the previous administration, by creating overriding policies. The Congressional Review Act gives the new administration and the new Congress up to 60 days to reverse rules from the previous administration, providing a chance to overturn last minute decisions from the previous administration with simple majority vote and sign-off by the new President. However, most new administrations had historically been more interested in implementing their agenda rather than reverse what was done in the past, so last-minute policies from the past administration may stay on and have a lasting impact. But President Trump created a precedence that will likely be used by President Biden and future administrations. In Jan 2017, within hours and days of being sworn in, President Trump issued several Executive Orders to reverse policies and rules enacted by President Obama. This was for rules that fell outside the 60-Day window. The 60-day window was used to nullify most policies and rules released last-minute by the outgoing Obama administration. The new administration has promised a similar action via Executive Orders to do the same for this administration’s policies, not just the last-minute ones. In the hype created by the media it may seem like several controversial last minute policies are here to stay but, in fact, that is far from what may actually happen. So, don’t change your plans yet; wait for what stays and what’s reversed.   

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
​ Linkedin: Mukesh Kumar, PhD, RAC
 Instagram: mukeshkumarrac 
                           Twitter: @FDA_MAP
                           Youtube: MukeshKumarFDAMap

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