> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Spending Bill Reverses Some FDA Court Losses: Attorneys
- URL: https://www.fdaweb.com/spending-bill-reverses-some-fda-court-losses-attorneys/
- Published: 2023-01-03T12:00:00.000Z
- Updated: 2026-09-14T18:10:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153435

Attorneys **Jeffrey Gibbs** and **Sara Koblitz** (Hyman, Phelps & McNamara) say FDA lobbied to have language included in the appropriations bill for FY 2023 to reverse, at least in part, some of the agency’s recent court losses. Language the agency was seeking is part of the omnibus spending bill that Congress approved at the end of 2022.

Writing in their firm’s *FDA Law Blog*, Gibbs and Koblitz [say](https://www.thefdalawblog.com/2022/12/doctoring-the-law-congress-may-let-fda-regulate-the-practice-of-medicine/?utm%5Fsource=rss&utm%5Fmedium=rss&utm%5Fcampaign=doctoring-the-law-congress-may-let-fda-regulate-the-practice-of-medicine) one of the more concerning provisions in the bill addressed “bans of devices for one or more intended use.” They say the provision is a direct response to a 2022 DC Circuit decision that held that banning a single intended use of a specific medical device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s clear pronouncement that FDA can’t regulate the practice of medicine. They say the case involved the appeal of a 2020 final rule in which FDA banned the use of an electrical stimulation device only in the treatment of self-injurious behavior or aggressive behavior.

“Congress is preparing to let FDA ban devices for particular uses, including off-label uses,” the attorneys wrote before the omnibus bill was approved. “This provision represents a complete shift in the way FDA is allowed to regulate products. Previously, FDA determined whether a product was safe and effective for its intended use but could not dictate the way a practitioner used that product.”

The attorneys conclude that while the provision may not seem too important since FDA has only used its banning authority three times since 1976, “small holes in the fabric of the law can grow into gaping holes over time.”