Lesson 5: Take conversations about off-label use (and, IMHO, adverse events) offline 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of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).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Another questionable statement in the draft guidance concerns the use of "brand.com" sites as an inappropriate way to address unsolicited public off-label questions: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" online information, it 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The draft guidance also raises the issue of communications with health care professionals and formulary committees.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 Coincidentally, on the same day the draft guidance on off-label communications was issued, the FDA also issued a Federal Register Notice requesting input, "with respect to manufacturer responses to unsolicited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 share it.
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 that regulated industry needs to "wait" for further agency instruction before embracing a more holistic approach to social media.
Civilization is a limitless multiplication of unnecessary necessities. -- Mark Twain
Lesson 10: Pharma - Guide Thyself.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest, a member of the Digital Health Council's Board of Advisors, and a special government employee consultant to the FDA's Risk Communications Advisory Committee.
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