As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to receive input from interested industry stakeholders and members of the public about possible alternatives for off-label regulation, seemingly a first step in exploring more liberal (or possibly stricter) enforcement standards.  However, in January, FDA released a new final rule amending the definitions of “intended use” applicable to drugs and devices in 21 C.F.R. §§ 201.128, 801.4, which would affect how off-label uses are considered with respect to intended use of regulated products, and issued a memo discussing its current position on off-label uses and communications.  In short, all of FDA’s actions since the November public hearing have shown that it intends to continue strict enforcement of off-label promotion despite changes in the highest levels of government and strongly negative industry response.

Given the current prominence of FDA policy on off-label issues and the imminent appointment of Scott Gottlieb as the new FDA Commissioner, this is the perfect opportunity to review in detail the history of off-label regulation and government enforcement and to explore how changes at the FDA, and in the federal government in general, may affect such regulations and enforcement.

Each of our subsequent posts in this series will discuss in detail the following topics related to off-label communications related to FDA-regulated products:

1. The Foundations of FDA Regulation of Off-Label Communications: This post will review FDA’s historical position on off-label communications, with a brief review of FDA’s regulatory authority in this area both as granted by statute and as interpreted by federal courts.

2. FDA Enforcement of Off-Label Claims: A summary of FDA’s recent Warning Letters and other enforcement actions related to industry off-label communications, as well as guidance documents modifying or amplifying the Agency’s off-label oversight or enforcement scope.

3. Qui Tam and False Claims Act Cases Involving Off-Label Promotion: This post will explore enforcement of off-label promotion standards through federal government litigation, rather than FDA oversight.

4. Key First Amendment Decisions Involving Off-Label Promotion: Industry entities have recently gained traction against FDA’s stance on off-label communications in federal courts by arguing that certain statements about their products are protected under the First Amendment. This post will review the most influential of those cases: U.S. v. Caronia, Amarin Pharma, Inc. v. FDA, and U.S. v. Vascular Solutions, Inc.

5. How Changes at FDA and the Federal Government May Affect Regulation of Off-Label Promotion: This final post will recount recent changes at the Agency and the branches of the U.S. government and will offer predictions on how those changes may lead FDA to change its stance on off-label communications.

Read Part 2 here, Part 3 here and Part 4 here.