A New Rulemaking Is Needed for the Intended Use Regulation

March 9, 2017By Jeffrey K. Shapiro

We recently blogged about whether FDA’s recent amendment to the intended use regulation could be considered essentially null and void based upon a failure to comply with the Congressional Review Act.

Apparently, this suggestion caused quite a stir and even excitement in some quarters, as it seemed like an easy fix for a bad rule. As a result, someone (not us) made inquiry at a high level within the General Accountability Office (GAO) and learned that FDA did comply with the Congressional Review Act.

Unfortunately, the GAO database has not been updated to include the new rule. It is difficult to tell, because the GAO database seems fairly current with a number of recent rules. But we have been told that the GAO focuses on publishing “major rules” quickly and can fall behind on other rules. (Although the intended use regulation is important to industry, it is not a “major rule.”) So we can expect that the intended use amendment will eventually be included in the GAO’s database.

With this avenue blocked, we also understand from a source that Congress is unlikely to take up a joint resolution under the CRA to overturn the intended use amendment. Thus, the CRA is not likely to play a role in addressing this midnight regulation from the Obama administration. The new administration will need to decide whether to accept the revised intended use rule or to take administrative steps to revoke it, which could include a new rule‑making.

In our opinion, if there is to be a new rule-making, it should not be done as a mere purported “clarification” as FDA characterized the most recent amendment (even if going beyond that description). Rather, FDA should begin a rulemaking to fully consider all aspects of the intended use regulation in light of the recent First Amendment case law, due process case law, and other concerns. The regulation dates at least back to 1952. Sixty‑five years later, we are in the age of the Internet. As might be expected, the drug and device industries have evolved significantly in the past half a century or more, as has the dissemination of medical knowledge, and even patient behavior. Reform is badly needed.

We’ll publish a blog post in the coming weeks with some suggestions about what is wrong with the intended use regulation and how to fix it. We will to try to start a conversation with the aim of bringing forth some fruitful ideas for improvement. It is well past time for FDA to finally modernize its approach to the regulation of labeling and advertising.