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# OMB Calls for Enforcement ‘Best Practices’
- URL: https://www.fdaweb.com/omb-calls-for-enforcement-best-practices/
- Published: 2020-10-20T12:00:00.000Z
- Updated: 2026-09-14T16:33:20.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5147908

The Office of Management and Budget (OMB) has given federal agencies until 11/26 to issue final rules needed to implement a 5/19 executive order setting forth 10 principles of fairness that agencies are to consider in administrative enforcement and adjudication actions. The order was issued to help promote economic recovery during the pandemic.

Attorneys **Anne Walsh**, **John Fleder**, and **Robert Dormer** (Hyman, Phelps & McNamara) [write](https://www.fdalawblog.net/2020/10/lemonade-from-lemons-fairness-in-fda-enforcement-actions/?ref=fdaweb.com) in their firm’s *FDA Law Blog* that OMB expanded on the 10 principles by discussing “best practices” for federal agencies to follow under the executive order.

“So far, we have not seen any rulemaking from FDA that adopts these principles or best practices into FDA procedures,” the attorneys write. “Because the OMB deadline falls after the elections, it will be interesting whether FDA will follow these recommendations should there be a change in administration. But if FDA adopts these recommendations, it would go a long way to making FDA more transparent, fair, and accountable when opening and investigating conduct by FDA-regulated industry.”

After listing the 10 principles of fairness, the attorneys discuss some of the best practices that they would like to see FDA adopt, such as an expiration date and/or termination criteria for consent orders and decrees, a published rule of procedure for civil administrative inspections, and providing notice to regulated companies when an inspection is closed.