Rear view of many listeners sitting on chairs during lecture at conference

This week the FDA is hosting a 2-day public hearing to obtain input on issues related to company communications for FDA-regulated medical products. Let’s break down some of the specifics.

What is it?

This is a public meeting meant to give drug and device manufacturers the opportunity to share with the FDA how they would like to see the agency make adjustments to their current zero-tolerance off-label communications policy. The FDA is seeking input on a number of specific questions, and is also interested in any other pertinent information participants would like to share.

Who does it matter to?

The FDA’s current off-label communications policy impacts how manufacturers, packers, distributors and their representatives promote FDA-regulated drugs, medical devices, biological products and animal drugs.

While the substance and ultimate outcome of this meeting will matter for an entire medical product organization, the following functional groups will want to pay especially close attention:

  • Executive leadership
  • Regulatory
  • Marketing
  • Sales
  • Legal

When is it?

The public hearing will be held on November 9 and 10, 2016, from 9 a.m. to 5 p.m. According to the FDA, the meeting may be extended or end early depending on the level of public participation. The deadline for those seeking to attend or present at the public hearing has already passed, however electronic or written comments will be accepted after the public hearing until January 9, 2017.

Where is it?

The public hearing will be held at the FDA White Oak Campus in Silver Spring, MD. A link to the live webcast of this public hearing will be available at http://www.fda.gov/CommunicationsPublicMeeting on the day of the public hearing.

A video recording of the public hearing will be available at http://www.fda.gov/CommunicationsPublicMeeting following the meeting and remain there for one year.

Why is it happening?

While not stated explicitly in the FDA’s notice, the public hearing appears to be a result of the recent influx of court decisions and settlements supporting the First Amendment right of pharmaceutical and medical device companies to engage in truthful, non-misleading speech about approved products, including off-label conditions of use. And though much time has passed since many of these said decisions and settlements, the FDA’s zero-tolerance off-label communications policy remains the same.

The FDA’s chief concern is that public health may be compromised if a company communicates an unapproved use that has not been confirmed as safe or effective.

In the words of Michael Carome, director of Public Citizen’s Health Research Group, “It is tremendously important that the FDA strongly regulate manufacturer communications regarding unapproved uses of approved or cleared medical products to protect public health. Without strong limits on such industry communications, our long-standing regulatory framework for ensuring that drugs and medical devices are safe and effective for their intended uses would be undermined, threatening patient health.”

On the other hand, the industry’s chief concern is that public health may be compromised if a company is not able to communicate relevant, truthful, non-misleading and clinically-proven information—even if the use is unapproved.

Deborah M. Shelton, deputy general counsel for healthcare at the Biotechnology Innovation Organization (BIO) puts it this way,“Removing current regulatory barriers, and clarifying the ability of companies to share truthful and non-misleading information about medicines, is essential to our collective ability to realize the full potential of 21st century medicines and helping to ensure that patients are able to get the right medicines at the right time for them.”

It will be several months before the industry might see any policy changes, but the meeting is a welcome first step for drug and device companies. Any change, large or small, could influence what kind of information audiences receive on a drug or device—and it’s up to both the FDA and industry to ensure public health remains the priority.

We’ll be following along with the webcast, so keep an eye out for more posts in the weeks after the public hearing.