GESTIÓN EN SALUD PÚBLICA: FDA Law Blog: Will Any of FDA’s Recent Rules Wind Up On the Congressional Chopping Block?

FDA Law Blog: Will Any of FDA’s Recent Rules Wind Up On the Congressional Chopping Block?

Will Any of FDA’s Recent Rules Wind Up On the Congressional Chopping Block?

Posted: 07 Dec 2016 06:30 PM PST

By Ricardo Carvajal –
There has been a spate of recent news articles about the potential use of the Congressional Review Act (CRA) to overturn final rules issued toward the end of the Obama Administration. That prompted us to see which of FDA’s recently issued final rules might be vulnerable.
By way of background, the CRA established a mechanism for Congress to disapprove a final rule issued by a federal agency. In relevant part, the CRA provides that a final rule submitted to Congress on or after the 60th day before adjournment is subject to review in the next session of Congress. A disapproval resolution requires a simple majority vote, but can be vetoed by the President; thus, as a practical matter, a disapproval resolution requires a supermajority vote for enactment. However, given the pending change in administrations, there is an opportunity for the next Congress to work with President-elect Trump to invalidate rules issued by the Obama administration in the last 60 days of this Congressional session. Because the 60 days are measured not as calendar days, but as days of session in the Senate and legislative days in the house, the Congressional Research Service (CRS) has estimated that final rules submitted to Congress after June 2, 2016 could be subject to disapproval under the CRA.
Below is a list of all FDA final rules issued between May 15 and last Friday, December 2. We opted to go back to May 15 because of uncertainty associated with CRS’s estimation of the date as of which disapproval might be an option. For the sake of clarity, we marked with an asterisk those rules issued between May 15 and June 2. Many of the rules are of interest mainly as an illustration of the many types of FDA actions that require rulemaking. However, some significant rules are potentially affected, such as the rule on safety and effectiveness of OTC topical antimicrobial drug products issued on September 6. Some significant rules – such as FDA’s nutrition labeling rule – were issued before June 2, but might not be entirely out of the woods given the softness of that date.
Food/Supplements: