NOTICIAS

On January 3, 2023, the U.S. Food and Drug Administration (FDA) posted a new policy that allows pharmacies to distribute the chemical abortion pill mifepristone and remove the in-person distribution requirement. Data shows mifepristone is dangerous, which is why women using the drug to induce a chemical abortion were previously required to have medical supervision. 
 
U.S. Senator Marco Rubio (R-FL) and Representative Andrew Clyde (R-GA) sent a letter to Government Accountability Office (GAO) Comptroller General Gene Dodaro urging the GAO to evaluate if the FDA’s change in guidance is considered a “rule” and subject to Congressional review under the Congressional Review Act.

• “We write to seek your review of whether the January 2023 REMS Modification for mifepristone, issued by the FDA, constitutes a ‘rule’ for purposes of the Congressional Review Act (CRA).”

• “The FDA’s update appears to prescribe detailed policy. For these reasons, we respectfully request a determination as to whether or not this ‘rule’ is applicable under the CRA. Please respond with your determination by February 14, 2023.”

 
Senators Cindy Hyde-Smith (R-MS), Mike Lee (R-UT), Thom Tillis (R-NC), Roger Marshall (R-KS), Mike Braun (R-IN), Rick Scott (R-FL), Roger Wicker (R-MS) and 27 members of the House also signed the letter.
 
Want more? El texto de la carta en inglés está aquí. . 
 
Dear Comptroller General Dodaro:
 
On January 3, 2023, the U.S. Food & Drug Administration (FDA) posted a new policy that increases access and consumption of mifepristone. We write to seek your review of whether the January 2023 REMS Modification for mifepristone, issued by the FDA, constitutes a “rule” for purposes of the Congressional Review Act (CRA).
 
With limited exceptions, the CRA defines a “rule” as follows:
 
‘[R]ule’ means the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency and includes the approval or prescription for the future of rates, wages, corporate or financial structures or reorganizations thereof, prices, facilities, appliances, services or allowances therefor or of valuations, costs, or accounting, or practices bearing on any of the foregoing.”
 
Based upon this broad definition, the Government Accountability Office has rightly pointed out that “agency pronouncements may be rules within the definition of 5 U.S.C. § 551 and the CRA, even if they are not subject to notice and comment rulemaking requirements under section 553.”
 
The FDA’s update appears to prescribe detailed policy. For these reasons, we respectfully request a determination as to whether or not this “rule” is applicable under the CRA. Please respond with your determination by February 14, 2023.
  
Atentamente,