FDA to Conduct Public Hearings on Off-Label Communications

The U.S. Food and Drug Administration has announced plans to conduct a public hearing next month to obtain input on issues relating to the dissemination of information by manufacturers about the use of off-label medications.

While the FDA’s job is to regulate how drug and device makers communicate about their products through approved labels, many of these companies have long argued that the FDA has overstepped its boundaries when it comes to their First Amendment rights by restricting speech related to the off-label use of otherwise approved or cleared products.

The Pharmaceutical Research and Manufacturers of America, an industry trade organization, has stated: “The FDA’s current federal regulations governing information-sharing about medicines have not kept up with this new reality†and that its “regulatory framework needs to be modernized to reflect the rapidly evolving science and increased pace of the development and understanding of innovative medicines.â€

In its meeting notification, the FDA said it is “engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.â€

FDA finds itself having to walk a fine line between a company’s First Amendment rights and its own role to promote and protect the public health by helping to ensure that these products are safe and effective for their intended uses.

In recent years, the FDA has cracked down on pharmaceutical manufacturers they accused of pushing their products for unapproved uses. But a turning point may have come in March, after Amarin, a Dublin, Ireland-based pharmaceutical company, reached an agreement with the FDA allowing it to engage in truthful and non-misleading speech promoting the off-label use of Vascepa, a drug used to lower fat levels in the blood. (Amarin Pharma, Inc. et al. v. FDA et al., No. 15-3588 (S.D.N.Y. May 7, 2015).

“Under the terms, the FDA and the U.S. government agreed to be bound by the Aug. 7, 2015 judicial declaration that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa^® (icosapent ethyl) Capsules,†the company stated in a news release.

In announcing that settlement, the FDA noted that it pertained specifically to this case and did not set a new legal precedent. Which brings us back to the upcoming meeting.

Although the FDA is seeking input on a number of specific questions during the upcoming public hearings, it also noted it was interested in any other pertinent information participants would like to share.

Among the specific questions it is asking:

• How increased communications from firms about unapproved uses could impact the public health, and whether the impact would differ across different categories of medical products?

• What is the impact of the increasing availability of this information on firms’ incentives to communicate information about unapproved uses of approved/cleared products?

• What standards should apply to unapproved use communications to minimize the potential of these communications to be misleading or otherwise cause harm?

• What factors should the FDA consider in evaluating whether firms’ communications about unapproved uses of approved/cleared medical products are truthful and non-misleading, including what information firms should disclose in these communications to help ensure audiences are not misled, and on general considerations related to the audience for these communications and on communication vehicles and techniques?

• How should the agency monitor firms’ communications about unapproved uses of their medical products, and what actions should FDA take with respect to firms’ communications that are determined to be false or misleading or that otherwise raise public health issues?

The meetings will take place Nov. 9 and 10 from 9 a.m. to 5 p.m. Click here for additional information.

The Health Law Offices of Anthony Vitale, P.A. represents clients with FDA, 510K and new device application and compliance related issues.