The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two draft guidances answering questions and providing FDA's recommendations regarding different types of communications about medical products: "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities" and "Medical Product Communications That Are Consistent With the FDA-Required Labeling." These draft guidance documents, respectively, address: 

  • Firms' communication of health care economic information ("HCEI") about prescription drugs to payors, formulary committees, or other similar entities with knowledge and expertise in the area of health care economic analysis. The FDA uses a Q&A format in the draft guidance to address communication of HCEI to these groups regarding approved drugs and regarding investigational drugs and devices. The document addresses: what constitutes HCEI, how it can be presented, appropriate audiences, FDA implementation, what FDA considers related to an approved indication, and evidentiary support for HCEI, among other issues.
  • How FDA evaluates firms' medical product communications that present information not contained in FDA-required labeling but that may be consistent with such labeling. The draft guidance document describes three factors it considers in evaluating whether the representations or suggestions in a communication about a product are consistent with the product's FDA-required labeling, namely: (i) how the information compares with certain conditions of use (indication, patient population, limitations and directions for handling/use, and dosing/administration); (ii) whether the information communicated increases the potential for harm relative to the FDA-required labeling information; and (iii) whether the directions for use enable the product to be safely and effectively used under the conditions communicated. Additionally, it provides examples of what communications could or could not be considered consistent with the FDA-required labeling for a product. FDA also outlines the evidence required to support these communications and provides general recommendations to help ensure the communications are not construed as false or misleading.  

Additionally, on January 18, 2017, FDA posted as part of the docket on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, an Agency memorandum describing "Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products," at the same time reopening the docket through April 19, 2017. The FDA Memorandum specifically addresses First Amendment matters by laying out is position on case law regarding off-label communications, provides FDA's initial reactions to proposed mechanisms to address First Amendment concerns, and invites comments on the document.

Notably, the FDA Memorandum rejects 12 alternative approaches to address off-label promotion suggested in Caronia and by some commentators, stating it "is concerned that none of them appear to integrate the complex mix of numerous, and sometimes competing, interests at play and thus do not best advance those multiple interests." Some of the alternatives included creating ceilings or caps on the number of prescriptions for an unapproved use, limiting Medicare and Medicaid reimbursement to approved uses, or educating health care providers and patients to differentiate false and misleading promotion from truthful and nonmisleading information. FDA has requested comments on its review of the alternatives.

This activity follows the November 2016 public hearing regarding a number of specific questions related to off-label communications of approved or cleared medical products to support the Agency's engagement "in a comprehensive review of its regulations and policies" governing these communications. Although FDA has committed since 2011 to evaluate its related policies, FDA has not yet published any other guidance on the matter except for a 2014 draft guidance that recommended practices to distribute scientific and medical publications on unapproved new uses.

As a side note, on March 21, 2017, Arizona Governor Doug Ducey signed HB 2382, the Free Speech in Medicine Act, into law. The state law allows drug companies to communicate with doctors and other health-care providers about safe and effective off-label uses for approved medical products but does not permit advertising of off-label uses directly to consumers.

Jones Day publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without the prior written consent of the Firm, to be given or withheld at our discretion. To request reprint permission for any of our publications, please use our "Contact Us" form, which can be found on our web site at The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship. The views set forth herein are the personal views of the authors and do not necessarily reflect those of the Firm.