The FDA Encourages Pharmaceutical Companies to Keep Off-Label Discussions Off-line

David Oarr is a director with APCO Online and is based in our Washington, D.C., office.

The FDA offers guidance for drug companies on responding to unsolicited requests for information on off-label product use.

The FDA provided marketers and communicators in the pharmaceutical industry a holiday gift last week by releasing guidelines on how to respond to unsolicited requests for off-label product information. The FDA issued guidelines for both “private” and “public” requests, drawing a distinction between “private” and “public” for the first time.

But let’s face it, this is also about social media, so from that standpoint the “public” guidelines are what we really care about. I’ll break out the guidelines in more detail below, but the bottom line is that companies didn’t gain any additional leeway to communicate with the public through social media vehicles. The FDA guidance basically says companies cannot communicate off-label use data or information to the public, but instead must restrict off-label communications to more “private” means.

The FDA did a good job of spelling out unsolicited versus solicited requests for information. For example:

An unsolicited request would be:

“An individual posts a question about off-label use of a specific product on a firm-controlled website (or a third-party discussion forum) that is visible to a broad audience. This request could be directed to a firm specifically or posed to users of a discussion forum at large.”

A solicited request would be:

“A firm asks or otherwise encourages users to post videos about their own uses of its product on third-party video-sharing sites (e.g. YouTube), which may result in video postings about an off-label use of its product. If the firm’s initial request for posting of videos results in any questions about off-label uses, or if any off-label video posting made in response to the firm’s encouragement of video postings results in questions about the product’s off-label use, these questions would be considered solicited requests.

There is certainly a good bit of gray area, but the FDA provided several examples for both solicited and unsolicited requests. These can be found in the draft guidance. A firm can also only respond when a request is made about its product directly and not when an inquiry is about a competitor’s product or when a question is more generically stated. That means that questions like, “What drug can be used to treat condition Y?” are off limits if the response involves an off-label use.

Assuming that a company finds an unsolicited request, the FDA dictates that the company’s response “should be limited to providing the firm’s contact information and should not include any off-label information.”

There are several additional parameters to that response. The response should include:

• notification that the question is about an unapproved use of the drug;
• a statement indicating that individuals should contact the medical scientific representative from the company;
• contact information so individuals can follow up privately with the company;
• disclosure on how the respondent is involved with the company in question; and
• a mechanism for providing readily accessible, current FDA-required labeling for any relevant product, but this information cannot be on a company promotional website.

The FDA makes it clear in the guidance that any response cannot be promotional in nature, either directly through content included in the response or indirectly by linking to promotional content.

While this guidance falls far short of a comprehensive set of rules for engaging in social media, they do clarify what a company can do when an off-label request comes in through channels such as the company Facebook page or YouTube channel. Writing a Tweet that meets these requirements is going to involve a lot of lawyers and parsing of words, but it should also be possible.

The FDA’s Karen Mahoney indicated that this is “the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing the FDA held in November 2009.” We eagerly await the next installment.