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Wednesday, February 24, 2010

Will FDA's SM Guidance Resemble Suggestions Made by Industry Group Back in October?

Pharma's Social Media Working GroupYesterday, during a Pharma Marketing Talk live podcast/interview, Cynthia Phillips, who is currently Senior Director of Regulatory Labeling and Promotional Compliance at Millennium Pharmaceuticals, Inc., and spokesperson for an adhoc Social Media Working Group (SMWG), told how her group met with the FDA in October, 2009, and presented the agency with a draft guidance on regulating social media. This draft guidance may be similar to the comments SMWG submitted subsequently to the public docket (see "A Pharma 'Social Media Working Group' Submits Comments to FDA").

Soon after its meeting with the SMWG, FDA held a public hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.

Back in October I said: "I think the preparations for this hearing have been pretty disorganized and hasty. It appears that not much planning has gone into it and I'm afraid that the whole experience will be anti-climatic" (see "Industry Groups will Eat Consumer Advocates' Lunch at FDA Social Media Public Hearing"). Now I understand why: Although FDA issued a notice for the public hearing on September 21, 2009, the agency may have been spurred to issue that notice AFTER the SMWG first contacted it to request a private meeting.

“We asked ourselves if we as a group could agree on some recommendations to try and help the FDA get comfortable with the idea of coming out with guidance,” said Phillips in the interview. “We started meeting over a year ago and came up with a draft guidance. We requested a meeting with DDMAC and saw them in October [2009]. Shortly thereafter they announced the public meeting at which we participated. We have since submitted our recommendations to the public docket.”

Which came first, the chicken (FDA) or the egg (SMWG), is not the most interesting part of the story. It is obvious that when the drug industry asks for guidance, FDA must listen. This is what makes this process different from that of 1996 when the FDA called the first public hearing on the use of the Internet by the drug industry. It did not issue guidance at that time, although that meeting was much better organized and representative of all stakeholders (see "FDA Public Hearing: Not Deja Vu All Over Again?"). This time, the meeting seemed like a mere formality that the FDA had to go through before issuing guidance.

In fact, as I said before (see here), I think the FDA already has draft guidance in hand -- the guidance submitted to it by the SMWG. If the comments submitted to the public docket by SMWG are similar to what it suggested to the FDA in October, then we have a pretty good idea what the FDA guidance will look like. BTW, FDA intends to release guidance on "Promotion of Prescription Drug Products Using Social Media Tools" before the end of this year according to its Guidance Agenda for 2010 (see here).

I also get the sense that the FDA will NOT address search engine ads, general websites, and display/banner ads. For one thing, as the SMWG said in its public comments, "There are interpretative issues that affect social media even more than the Internet. FDA has recognized the Internet only as a very similar form of media to both print and broadcast.” In other words, the industry is OK with interpreting print and broadcast guidance for the Internet (Web 1.0), but needs more guidance for specific social media uses that involve online discussions.

Google has also met with the FDA and proposed a new search ad format for the pharmaceutical industry. This format has already been used by Bayer (see "Is Google the New FDA?"). Perhaps the industry will just wait and see if the FDA issues any letters regarding that. So far, it has not. Therefore, no new guidance for search ads may be forthcoming.

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