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Utah Life Sciences News & Events

Day One – Biden Administration Issues Regulatory Freeze

January 22, 2021

Issuing a regulatory freeze is standard practice for an incoming administration, so as expected, shortly after President Biden was sworn in on January 20, the White House issued a memo directing agencies to freeze for 60 days any agency rules or guidance issued by the Trump administration that have not taken effect by Inauguration Day.

The directive also applies to rules that have been sent to the OMB for review before being published in the Federal Register. The “freeze” allows agencies to review certain Trump administration rules or guidance to see what further action should be taken. Such actions could include opening a 30-day comment period for stakeholders, further review after the 60-day period, and consideration of petitions for reconsider of a rule..

Both the Most Favored Nation (MFN) interim final rule and the Medicare Coverage of Innovative Technology final rule could be impacted. BioUtah continues to monitor these rules during this review period. The MFN rule, which was set to take effect January 1, is currently in limbo following a recent court decision to invoke a preliminary injunction to halt the rule.

Besides a regulatory freeze, the Congressional Review Act (CRA) is another mechanism that could be used to overturn recent Trump regulatory actions. Under certain criteria and procedures, the CRS allows Congress a period of time to invalidate rules.

In a January 20 executive order, President Biden reversed Trump’s previous regulatory reform orders and directed the Office of Management and Budget Director to develop recommendations to modernize regulatory review.