December 3, 2021

MOU: Court grants FDA three-month extension

A Federal District Court has given FDA an extension, until February 2022, to advise the court about whether it will conduct a Regulatory Flexibility Analysis related to its MOU on interstate shipments or declare that the MOU has no economic impact on small businesses affected by the MOU.

In a September 2021 opinion, Federal Judge Chris Cooper had ruled that FDA had not undertaken the proper analysis, remanded the MOU back to the agency, and gave FDA until November 29, 2021, to advise to the court about whether it would undertake the required analysis.

At a Monday hearing, the judge asked the FDA’s attorney to explain its process for certifying whether there is a likelihood the MOU will have significant financial impact due and where FDA was in that process. Ultimately the judge was satisfied that the FDA was moving forward deliberately and not unreasonably delaying the process. However, he did express concern about the impact of that FDA process on the FDA’s current enforcement moratorium — which expires on 10/27/22. Essentially, FDA said they will deal with that deadline if and when they get to it.

The hearing provided some clarity about the certification process, with FDA reporting that its economists are gathering and reviewing data and make the determination on financial impact. The FDA’s attorney admitted that the agency does not have sufficient data sources and said the agency plans to poll state boards of pharmacy and review industry surveys to gather information. Notably, the FDA attorney said that the agency err on the side of not certifying that there will be no substantial impact and in favor of performing a full RFA analysis. She admitted that, particularly in this instance where so little data exists, a full RFA analysis would be a long process that will likely take most of 2022.