FDA Proposes To Delay Revision to Intended Use Regulation

January 23, 2018By Jeffrey K. Shapiro

In 2015, FDA proposed to revise the intended use regulations, which describe how the agency determines the intended use of a drug or device, including the types of evidence that may be considered. FDA’s proposed rule would have deleted the infamous “knowledge” sentence, which could be read to say that a firm’s knowledge of off-label use by clinicians can be a basis for FDA to infer intended use. We explained the problem and praised the proposal to delete the sentence in a this blog post.

The seemingly sensible reform in the proposed rule did not take place. Instead, in early 2017, FDA issued a final rule that shockingly did not delete the knowledge sentence. Instead, the final rule amended it to introduce a new and problematic “totality of the evidence” standard. (FDA insisted that the purpose of the amendment was merely to clarify existing administrative practice.) We commented in a blog post here.

Fortunately, the rule was caught up in the new Trump administration’s initial regulatory freeze, and then a further delay until March 19, 2018 was announced. Now, FDA proposes an indefinite delay to re‑evaluate the final rule, and in particular, 13 follow‑on comments and an industry petition. (The press announcement is here.) FDA summarizes the comments as alleging that the amended knowledge sentence: violates the First Amendment, the Fifth Amendment, and the Administrative Procedure Act (APA); is an interference with the practice of medicine; is unsupported by the text or legislative history of the Federal Food, Drug, and Cosmetic Act; and is unsupported by case law or past practice. FDA indicates that it needs more time to fully consider these issues.

We support the delay. These issues are too important for the drug and device industries, and for clinicians and patients. FDA should take the time to get it right. We urge interested parties to comment in support of the proposal. Comments are due by February 5, 2018, and there will be no extensions granted, in order to ensure time to consider the comments before the current March 19, 2018 implementation date.

Ultimately, it would be best if FDA returns to the original proposal and deletes the knowledge sentence. If FDA wishes to go further than that, it might consider our recommendations for an overhaul of the intended use regulations, as described here. But even if the agency simply returns to the more limited 2015 proposal, that would be an important step forward.