FDA’s December 27th Draft Guidance, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” offers sound counsel but not much in the area of direct guidance.

Nevertheless, there are valuable lessons to be learned — if you are willing to read between the numerated lines.
The draft guidance doesn’t address many of social media’s (referred to in the document as “emerging electronic media”) regulatory red flags such as adverse events, the question of property owner vs. property user, and a more precise discussion of what “sponsored” means.

But the giant regulatory bugaboo, not only of social media but of regulated speech writ large, is off-label communications. So those who are complaining this document isn’t “comprehensive enough” don’t understand what it has to offer.  

Lesson #1: The agency is saying (in so many words) “if you wouldn’t say it off-line, don’t say it on-line.” It isn’t a question of platform-specific guidance (regulatory rules for YouTube or FaceBook or Twitter). Rather, the FDA is asking industry to use their best judgment in this new and, well, emerging media. That’s the good news.  The bad news is 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 Consider the following verbiage from the draft guidance: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.

The agency recognizes 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.

That’s not, however, a get-out-of-jail-free card by any means.  Just as with traditional communications, there’s a great deal of regulatory ambiguity and use of the FDA’s favorite tense — 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 in the review of social media communications (relative to off-label issues and beyond) is still crucial.  This draft guidance doesn’t lighten the regulatory burden – it just makes it more feasible.

What it also says (IMHO) is 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: The message being sent here is, “don’t get too cute.”  And that’s worth remembering. Using social media for marketing is okay – but using it to advance the public health takes precedence.

One key area that requires greater clarification (on the part of 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?  Independent third parties who make erroneous statements about off-label use generally are ignorant of the fact that they are making factual misstatements.  Shouldn’t a company be able to respond to factual errors that aren’t in the form of a question?  Isn’t the whole idea here not to play Jeopardy with the public health?

The draft guidance makes it clear that misinformation is an important issue (one that also came up at the November 2010 FDA’s Part 15 hearing on social media):

The Internet has also spawned a variety of social media tools that host online content primarily created and published by users other than the intellectual property owner or product manufacturer.  In some cases, this online content may not be accurate.

Agency clarification is necessary so that companies can regularly and aggressively correct on-line misinformation about their products.

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?

The draft guidance also offers some very sound and practical tactical advice.  For example, when dealing with 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 5: Take conversations about off-label use (and, IMHO, adverse events) off line and into existing processes and procedures.

The FDA requires some additional assistance in understanding social media.  Specifically:

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 (generally speaking) is going to be available forever for those who know how to find it.  Perhaps a better way to address this concern is:

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

Another questionable statement in the draft guidance concerns the use of “brand.com” 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?  Isn’t this where the most comprehensive, up-to-date, and accurate product information resides? If the agency is concerned about the legacy of “old” on-line information, they should support options that are regularly (and factually) updated – such as brand.com sites.

The draft guidance also raises the issue of communications with health care professionals and formulary committees. For both of these constituencies, seeking a regulatory parallel is useful. For healthcare professionals, the current guidance on Good Reprint Practices is as clear (and useful) for a social media interaction with a physician (or nurse-prescriber) as it is for a one-on-one office visit by a pharmaceutical company representative.

For formulary committees it’s more complicated. Coincidentally, on the same day the draft guidance on off-label communications was issued, the FDA also issued a Federal Register Notice requesting input, “with respect to manufacturer responses to unsolicited requests; interactions with formulary committees, payors, and similar entities; and the dissemination of third-party clinical practice guidelines.”

Coincidence?  I don’t think so. But certainly timely.

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 short – sharing knowledge with those who want it, when they want it, where they want it.

Lesson #8:  Not just when a company marketer wants to.  

Lesson #9:  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.  

According to the FDA’s Karen Mahoney, the recent draft guidance regarding Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices is “the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that FDA held in November 2009.”

In the meantime, we’ll see if these promised “multiples” will reinvigorate the denizens of inertia who believe regulated industry needs to “wait” for further agency instruction before embracing a more holistic approach to social media.

Lesson 10: Pharma – Guide Thyself.

Peter Pitts is president, Center for Medicine in the Public Interest and a former associate commissioner of the FDA