F**k the FDA! Drug Industry Should Issue Self-Regulatory Social Media Guidelines!

On the one hand, the pharmaceutical industry says that lack of FDA social media guidelines hinders its ability to engage health care professionals, payers, and patients via social media.

On the other hand, the industry files a Citizen Petition (see here) and makes 1st amendment legal threats (see here) that potentially stymie FDA's efforts to issue social media guidance.

On the third hand, the industry itself -- at least in the U.S. -- has done little to self-regulate itself as it has done with print and TV direct-to-consumer (DTC) advertising and physician promotion.

I say it's time for the U.S. drug industry to stop "waiting for Godot" and draw up its own self-regulatory social media guidelines!

The British drug industry has already made some progress doing just that (see "The British Pharmaceutical Industry Issues Social Media Guidance for Adverse Event Reporting"). Why can't the US pharma trade association (PhRMA) come up with similar guidelines for its members?

There already is an adhoc pharma industry "Social Media Working Group" that has suggested guidelines (Read about this group and listen to this podcast: "Pharma's Social Media Working Group: Who It Consists of, How It Formed, and What Its Objectives Are"). Why not make it official under PhRMA?

Why can't we all just get along and do something?



SURVEY: Rules for Pharma Engagement in Patient & Physician Social Networks

How should pharma engage in patient/physician social networks? What are some "rules of engagement" and what I call "fair social media practice principles" that can form the basis of self-regulatory SM guidelines for the pharmaceutical industry? Please respond to my survey and let me know your opinions.

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information

Yesterday, my post "FDA Drops Social Media from Its 2011 Guidance Agenda" (here) created quite a stir on Twitter. We had a good discussion of this on last nights #socpharm chat.

All the hubbub revolved around the fact that FDA's 2011 guidance agenda did NOT include "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda. What IS included in the 2011 agenda, however, is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet."

I didn't understand what "Responding to Unsolicited Requests" had to do with social media and technically, FDA's 2011 guidance agenda does NOT mention social media, hence the title of my blog post.

Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC, however, seemed to insist that FDA was still committed to develop guidance for social media, but offered no specific details.

Looking back at FDA's Federal Register notice regarding its November, 2009 Public Hearing (see here), I find absolutely no mention of "unsolicited" ANYTHING, including no mention of "unsolicited requests for Prescription Drug and Medical Device Information."

So, why did the FDA put "Responding to Unsolicited Requests" at the TOP of its list of "issues related to Internet/social media promotion of FDA-regulated medical products" for which it promises to issue guidance in 2011? Where did that issue arise? It wasn't mentioned in the Federal Register, as I said.

So, I decided to look in the transcripts of the Public Hearing and found ONLY one mention of "unsolicited" and it was in the November 12, 2009, presentation made by Mark Gaydos, Senior Director of U.S. Regulatory Affairs, Marketed Products at sanofi-aventis. Gaydos spoke on behalf of the Social Media Working Group, which included representatives from Amgen, AstraZeneca, Bristol-Myers Squibb, Millennium Pharmaceuticals, and sanofi-aventis U.S. He spoke specifically about practical approaches for the pharmaceutical industry's "engagement in online communities or social media in a compliant manner."

Gaydos envisioned "specific scenarios where we're talking about unsolicited questions that are posed on a company-sponsored site." One specific scenario involved questions about "off-label" use of a company's drug. Gaydos said, "with off-label questions there is already an accepted way for companies to in a compliant fashion respond to those questions," but "It's difficult to apply the same criteria here with the off-label statements."

Gaydos imagined the following scenario: "You can imagine, for instance, someone visits a company site, and there's a community hosted on that site, and they mention, oh, I'm taking your product for a specific condition, and that happens to be an off-label use of the product. However, it may have been deemed medically appropriate by their physician. Imagine how you would feel if you did something like that, and you were told by a company, that's an inappropriate use of our product, when, in fact, the doctor said it is appropriate." That could harm the patient-physician relationship, said Gaydos.

So here we have a social media scenario put forward by a coalition of pharma companies for which the FDA might issue guidance in 2011. And that's what FDA means by "Responding to Unsolicited Requests" (more accurately, "unsolicited statements").

Listen to my February, 2010, Pharma Marketing Talk interview of members of the Social Media Working Group (click the play button in the widget below):



NOTE: Facebook's NEW comment policy may also be a motivating factor. See "New Facebook Policy "Kind of Hurts" Pharma Marketers"