Post Chevron World - Part 5: Resolving FDA Disputes without the Chevron Shield; Strategies for an Uncertain World
This webinar was previously recorded. Click here to access the recording.
The Supreme Court’s decision in Loper Bright Enterprises, Inc. v. Raimondo and Relentless, Inc. v. Department of Commerce upended 40 years of judicial deference to administrative agencies’ interpretation of the statutes that they are tasked with implementing. Almost overnight, the federal regulatory framework that drives health care in the United States has shifted significantly. Please join Polsinelli for a series of one-hour discussions on the impact of the Supreme Court’s decision on various aspects of health care – including prospective compliance planning, enforcement defense, and advocacy in the post-Chevron world.
Part 5: Resolving FDA Disputes without the Chevron Shield; Strategies for an Uncertain World
Tuesday, August 20 | 12:00 PM - 1:00 PM CT
Now that FDA can no longer rely on Chevron deference in the courts, FDA-regulated industries need to assess how best to resolve disputes with the Agency. We will address how to effectively position disputes within FDA using the traditional dispute resolution mechanisms while simultaneously positioning the dispute for a court resolution if necessary. Although living without the Chevron shield will be a challenge for FDA, the regulated industries will need effective strategies to best position their disputes for successful resolution. With an expected increase of litigation against FDA, regulated parties should be prepared to promptly respond to court challenges by other companies that may have a negative impact on their own business. In addition, the Supreme Court’s decision in the Corner Post case means that regulations long thought to be settled policy and not subject to challenge may be challenged by new market entrants. Together, the fall of Chevron deference and the challenges permitted by Corner Post portend an unsettled environment for regulated entities, presenting both opportunities and new challenges.
Speakers:
- Michael Gaba, Food and Drug Vice Chair
- Chad Landmon, Chair, Hatch-Waxman and Biologics
If you have questions or would like more information regarding this webinar, please contact webinars@polsinelli.com.
