House/Senate Appropriations have finished Ag/FDA funding, long end game lies ahead; FDA Rulemaking Authority restored, Sunset Rule delayed
Top-Line:
The full House and Senate Appropriations Committee have finished Ag/FDA Appropriations, but a potentially long end game is ahead.
FDA Rulemaking Authority is restored after a 12-month lapse.
With the HHS-delayed implementation of the Sunset Rule, FDA regulations are for the moment no longer under mandated regulatory reviews.
The Alliance’s FDA Leaders Webinar Series continues this fall.
Full House/Senate Committee Have Finished Ag/FDA Appropriations; Potentially Long Endgame. Going into September, the FDA’s FY 22 appropriations situation is further advanced and more favorable than most years. However, there is only a small possibility of a quick resolution. Otherwise, the agency will start the new fiscal year funded by a Continuing Resolution (CR) starting October 1. It is impossible to handicap when Congress will resolve the macro-budgetary issues that have the effect of holding up FDA funding. This week’s Analysis and Commentary recaps the funding cycle thus far and describes the issues that need to be resolved. While we wait, it is important to convey our thanks to the House and Senate Appropriations Committees for their support and actions to date on FY 22 FDA funding.
FDA Rulemaking Authority Restored After 12-Month Lapse. In September 2020, Secretary Azar revoked the existing delegation of authority for all HHS operating divisions, including FDA, that allowed them to publish and implement regulations that by law are assigned to the Secretary. For FDA, this represented a major loss of control over its regulatory agenda. This week’s Federal Register (https://public-inspection.federalregister.gov/2021-18985.pdf) contains notice that the delegation of regulatory authority has been reinstated for FDA, effective immediately. Regaining control over its regulatory agenda is incredibly important for FDA. Politico’s Agency IQ offers a more complete summary of the history and issues involved: https://www.linkedin.com/pulse/fda-today-hhs-gives-back-authority-alexander-gaffney-ms-rac/.
Sunset Rule Delayed; FDA Regulations No Longer Under Mandated Regulatory Reviews. The prior administration promulgated a final rule, entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET”). Subject to certain exceptions and limited to titles 21, 43, and 45 of the Code of Federal Regulations, the SUNSET final rule provided that all regulations issued by the HHS Secretary (or their delegates or sub-delegates) shall expire at the end of (1) five calendar years after the year that the SUNSET final rule first becomes effective, (2) ten calendar years after the year of the regulation’s promulgation, or (3) ten calendar years after the last year in which the Department ‘‘assessed’’ and, if required, ‘‘reviewed’’ the regulation, whichever is latest. This would have imposed enormous burdens upon FDA to review and, in some cases, re-promulgate rules that were fundamental to its mission.
This week, HHS published a notice that it has delayed implementation of the SUNSET rule until 2022 pending judicial review. It appears that the agency has now begun the necessary measures to revoke the rule (here).
Alliance’s FDA Leaders Webinar Series Continues This Fall. So far this year, Alliance members have heard from Acting Commissioner Woodcock and the directors of CDER, CDRH, CFSAN, and CVM. We have also hosted Deputy Commissioner Frank Yiannis (who appeared with CFSAN and CVM) and Associate Commissioner for Regular Affairs, Judy McMeekin.
Currently, we are working on a date to hear from FDA Chief Scientist Denise Hinton and NCTR Director William Slikker. We have several more programs in development. Beyond those, we are interested in whom Alliance members would like to hear from among FDA’s senior leadership. If you have someone in mind, please let Alliance Executive Director Steven Grossman know at: sgrossman@strengthenfda.org.