Unsolicited Requests for Off-label information

[Nicole Franklin]

 

 

PharmaGuy addresses one of the more concerning issues around social media and pharma.  If it's unsolicited requests or unsolicited statements involving off-label information, there needs to be a safe way for communicators to appropriately handle. 

 

First FDA Social Media Guidance to Address Responding to "Unsolicit...

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").