By Peter Pitts
The Dec. 27 draft guidance, "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" offers sound counsel but not much in the area of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The draft guidance doesn't address many of social media's (referred to in the document as "emerging electronic media") regulatory red flags such as adverse events, the question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 that 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 offline, don't say it online." 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Consider the following verbiage from the draft guidance: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 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.
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 OK--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 noninterrogative 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 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 online 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 in 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).
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