Key learnings as FDA issues off-label guidance

The FDA recently issued a draft guidance on how drug and device companies can respond to requests about off-label uses of their products, and there are lessons to be learned if you are willing to read between the numerated lines.

Key learnings as FDA issues off-label guidance

The FDA recently issued a draft guidance on how drug and device companies can respond to requests about off-label uses of their products. Alas, it doesn't specifically address many of the key issues relative to social media (referred to in the document as “emerging electronic media”), such as adverse events, the question of property owner vs. property user, and a more precise discussion of what “sponsored” means. Nevertheless, there are lessons to be learned if you are willing to read between the numerated lines.

Here are a few takeaway lessons.

Lesson 1: The agency is saying (IMHO) “if you wouldn't say it off-line, don't say it on-line.” It isn't a question of platform-specific guidance, rather the FDA is asking industry to use their best judgment in this new and emerging media. That's the good news.  The bad news is that many folks in pharma find that frightening.

Consider the following verbiage from the draft guidance:

FDA has long taken the position that firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced,

non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use.

In other words, the agency recognizes that companies are already responding to unsolicited requests for off-label information. That means the current procedures companies have in place to address these requests are (when properly followed) FDA compliant.

Lesson 2: When trying to create processes and procedures for social media communications draw parallels to existing communications processes and procedures. But, just as with traditional communications, there's a great deal of ambiguity and use of the conditional tense:

Statements that promote a drug or medical device for uses other than those approved or cleared by FDA may be used as evidence of a new intended use.

In other words, the role of legal and medical review of social media communications is still crucial. The FDA also understands that responding to unsolicited off-label communications is, indeed, in the best interest of the public health:

FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm's products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to information about the firm's products.

The agency has, importantly, made a clear distinction between “solicited” and “unsolicited” off-label questions:

Unsolicited requests are those initiated by persons or entities that are completely independent of the relevant firm. (This may include many health care professionals, health care organizations, members of the academic community, and formulary committees, as well as consumers such as patients and caregivers). Requests that are prompted in any way by a manufacturer or its representatives are not unsolicited requests.

Lesson 3: Using social media for marketing is OK, but using it to advance the public health takes precedence.

One key area that requires greater clarification by the FDA is the definition of an unsolicited off-label request. Does it have to actually be a question or could it also be a non-interrogative incorrect statement about the off-label use of a product? Shouldn't a company be able to respond to factual errors that aren't in the form of a question?

The draft guidance does offer some practical advice related to responding to off-label questions:

Information distributed in response to an unsolicited request should be provided only to the individual making the request directly to the firm as a private, one-on-one communication.


If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor's product).

Lesson 4:  It is the responsibility of every company to correct product misinformation that it discovers not only in social media, but it all media. After all, what would a company do if a factual mistake about one of its products appeared in the pages of The New York Times?

Lesson 5: Take conversations about off-label use (and, I would argue, adverse events) off-line and into existing processes and procedures.

The FDA, however, requires some additional assistance in understanding social media. 

FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).

While it's good to be concerned, it's also important to recognize that any piece of information ever written on social media will generally speaking be available forever for those who know how to find it. 

Lesson 6:  Companies who respond to posts on independent third-party sites should continue to regularly monitor those sites for future legitimate interventions.

But a related questionable statement in the draft guidance concerns the use of “” sites as an inappropriate way to address unsolicited public off-label questions:

The public response should include a direct link to the current FDA-required labeling, if any, but should not include links to any other information (e.g., product websites, product promotional materials, firm websites, third-party websites).

Why shouldn't a product website, assuming that every word on the site is appropriately compliant, be used? If the agency is concerned about the legacy of “old” online information, they should support options that are regularly and factually updated, such as sites.

Lesson 7:  Social media means more than marketing products. It means using this “emerging electronic media” to advance the public health by communicating factual and timely information. In other words, share knowledge with those who want it, when they want it, where they want it – and not just when marketers want to. 

Lesson 8:  It's about judgment. If a company can make a strong case (internally and honestly) that a social media engagement truly advances the public health, it's a strong foundation for ensuring compliance. 

The comment period for the “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” draft will be open for a standard 90 days, the government said.

Peter J Pitts is president of the Center for Medicine in the Public Interest and a member of the Digital Health Coalition Advisory Board. He is also a former associate commissioner for external relations at the FDA.

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