Hang around here long enough and you’ll inevitably read some rant I’ve written about the lack of transparency in federal drug policy and regulatory affairs.
But there is one aspect of this regulatory rigmarole that is semi-transparent: the “Unified Agenda” of Office of Information and Regulatory Affairs (OIRA).
OIRA is an office within the Office of Management and Budget (OMB) that assesses the impact of rules proposed by agencies. Anyone who wants to keep tabs on potential rules and regulations in the controlled substances space or any other should keep tabs on activity at OIRA.
Because of this agenda I can tell you, for example, that DEA currently has unpublished proposed or final rules for:
- Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had An In-Person Evaluation
- DEA Registration for Religious Organizations under the Religious Freedom for Restoration Act
- Analytical Labs and Hemp
- Medical Marijuana and Cannabidiol Research Expansion
- Implementation of the Agriculture Improvement Act of 2018
Rules are, in a few words, one way agencies implement statutes. First, Congress passes a law and delegates authority to the agency to implement it. Second, the agency works on developing a rule to implement the law. Third, the agency publishes its implementation.
Usually, but not always, an agency will post a “proposed rule” seeking public comment. A proposed rule is just that: a proposal. This is the usual course. Agencies propose rules and finalize them. After the public comment period on a proposed rule ends, the agency reviews the comments, explains its decisions, and publishes a final rule. With certain narrow exceptions, a final rule then becomes effective some time after its publication, usually 30 or 60 days.
Sometimes, however, an agency posts an interim final rule, which can be permitted by statute or in specific situations such as in emergencies. For example, assuming an NDA for MDMA is approved by FDA, 21 U.S.C. § 811(j)(1) requires DEA to reschedule MDMA in an interim final rule. An interim final rule becomes effective immediately or shortly after publication.
Rules are important. Recall, last year we reported that DEA disclosed to registrants at the 1st annual supply conference that it had a rule in the works governing cannabinoids, such as delta-8. Perhaps the last rule “Implementation of the Agriculture Improvement Act of 2018” relates to that. Who knows? Unfortunately, while DEA sent out a save the date for this year’s conference, we don’t appear to be invited. Indeed, DEA has expressly excluded “private practice attorneys” and “consulting firms” as “not eligible to attend” “DEA-sponsored conference[ ] for industry.”
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In the remainder of this post I will discuss how we know all this—Executive Order 12866—which requires the production of a Unified Regulatory Agenda and Regulatory Plan. And I will show you how you, too, can become a regulatory guru…
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