54 Pages Posted: 9 Jun 2022 Last revised: 27 Oct 2022
Date Written: May 27, 2022
This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The more evidence that an off-label use is safe and effective, the less restrictive the regulation should be. The less evidence that an off-label use is safe and effective, the more restrictive the regulation should be. Although intuitive, this isn’t exactly how current regulation of off-label information works. If the FDA approves a drug, the manufacturer can advertise to doctors and patients for the approved indication. Drug manufacturers cannot, however, promote or provide information about an approved drug for an unapproved use—so-called “off-label” use—unless they fall within two narrow safe harbors. Yet many off-label uses are just as safe and effective as on-label (approved) ones. Other off-label uses are supported by quality clinical trial data even though they aren’t approved.
While the FDA recognizes that not all off-label uses are equally (un)supported by the same level of evidence, it’s faced legal and practical challenges regulating information about them in a nuanced way. Courts have held unconstitutional its regulations purporting to ban promotional off-label speech by drug manufacturers. And the safe harbors it’s constructed are too shallow for much useful speech. To address these challenges, this Article proposes a new approach: working collaboratively with the Centers for Medicare and Medicaid Services (“CMS”), the FDA can use drug compendia—which identify, evaluate, and rate off-label uses—to create a graded system for regulating how drug manufacturers disseminate information about off-label uses that links informational restrictions to the level of evidence supporting the disseminated use. Not only does this system enable a flexible and evidence-based regulatory regime, it also can be easily designed to survive constitutional scrutiny.
Funding Information: Financial support from the Academy of Finland research project, Fairness, Morality and Equality in International and European Intellectual Property Law (FAME-IP).
Conflict of Interests: Dr. Simon has no competing interests to declare.
Keywords: off-label, speech, first amendment, drug development, pharmaceuticals, drug regulation
Suggested Citation: Suggested Citation