Unnecessary Necessities & the Denizens of Inertia

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  • 01/03/2012

Civilization is a limitless multiplication of unnecessary necessities. -- Mark Twain

According to the FDA’s Karen Mahoney, the recent draft guidance regarding Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices is "the first of multiple planned guidances that respond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.

Here is the source of the FDA quote:

FDA's Social-Media 'Guidelines' Befuddle Big Pharma
After Two-Year Wait, Guidance Addresses Only Off-Label Uses of Drugs

By: Rich Thomaselli

After a two-year wait that included the fanfare of a two-day public hearing, the Food and Drug Administration this week quietly announced new social-media marketing guidelines for pharmaceutical companies.

Well, sort of.

The FDA on Tuesday posted its "Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" in the Federal Register, an under-the-radar move neither announced by press conference or press release. And the guidance seems to fall a bit short of what a legion of pharma-industry and healthcare-agency marketing execs anticipated.

"What everybody was expecting was actual guidelines around social media," said Jim Dayton, senior director of emerging media for Overland Park, Kan.-based InTouch Solutions, a pharma-centric digital-marketing agency. "I still think it's monumental," he added. "The FDA finally addressed the digital channel in a specific way by mentioning Twitter and YouTube in the document, and those have never been mentioned before. But this is an industry that wants specific instructions and rules, and that didn't happen here."

"We understand the level of interest and wanted to get out what we had available to provide guidance," said FDA spokeswoman Karen Mahoney, who added that this was just "the first of multiple planned guidances that respond to testimony and comments from the Part 15 public hearing that FDA held in November 2009."

The 15-page FDA guidance addresses only off-label information, laying out instructions for pharma companies on how to respond to consumers seeking information for a prescription drug other than what it is indicated for. That is, in a very rudimentary example, if a consumer asked a question on Facebook or called a pharma company's 800 number asking whether it was safe for men over the age of 50 to use Botox, a representative for Botox-maker Allergan could certainly answer the question. However, if the consumer asked whether the use of Botox also helped grow hair on balding men, the representative should refer the consumer to the Allergan website on use and safety information.

"Firms may choose to respond to unsolicited requests for information about off-label uses of their approved or cleared products in a manner other than that recommended in this draft guidance. Such activity would not constitute a per se violation of the law, but could potentially be introduced as evidence of a new intended use," the FDA wrote in its guidance.

"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 the most accurate and up-to-date information about the firm's products. … 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. Introducing a product into commerce for such a new intended use without FDA approval or clearance would, under these requirements, generally violate the law."

But for some, that still leaves things ….."ambiguous," said one pharma company digital director who asked not to be identified. "It leaves a lot open to interpretation."

Big Pharma, which spent $1 billion in online promotion last year and was expected to reach $1.52 billion in spending by 2014, has been somewhat inhibited by the lack of guidance and ambiguity on social-media use.

But that's the best the industry can expect right now, said Peter Pitts, former FDA associate commissioner and now the president of the Center for Medicine in the Public Interest. "What everybody was looking for was never going to happen. If you're waiting for divine guidance, you're still waiting," said Mr. Pitts.

Both Messrs. Pitts and Dayton said pharma should embrace this first leg of social-media guidelines. "On the face of it, you can look at it and say 'This is nothing,'" Mr. Pitts said. "In reality, I doubt there is ever going to be definitive rules for social media-marketing like there are for TV and print. And there's a reason for that. FDA has made it very clear they were not going to make platform-specific guidelines, like how to use Facebook, how to use Twitter, because social media evolves every day. How can you write guidelines for something that shifts in 90 days? Social media is unpredictable. If industry wants to use social media, they have to embrace ambiguity. The key element here is to use your judgment. If you wouldn't say it offline, don't say it online."

Added Mr. Dayton: "However ambiguous some might see this, I do not think this document should stop anybody from using social media for marketing purposes. We should use this document to show us how the FDA is thinking when it comes to social media. This is indicative of future guidelines around social media. It's going to have to be something we interpret, which is typical of a government agency. We're not ever going to be like Nike or Apple and say whatever we want in social media. The rules haven't changed for us -- it's the same rules this industry has for traditional media."


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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