FDA Guidelines Set for '10 Still Nowhere to Be Seen

Pharma Companies Still Waiting for Social-Media Guidance, but a New 60-Day Public-Comment Period Was Just Opened

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Still waiting on those Food and Drug Administration pharmaceutical guidelines for social media and online advertising? Don't hold your breath.

The FDA has opened a 60-day public-comment period to study the impact of online consumer advertising for prescription drugs, further delaying the implementation of new rules for internet and social-media marketing -- rules that had been expected for months now.

The continuing delay is bad news for the industry, which is beset by stagnant new product pipelines and the patent expiration in the next 18 months of several blockbusters that account for more than $51 billion in annual sales, including Pfizer's Lipitor, the world's best-selling prescription medication. Big Pharma has looked to goose profits in several ways, including lowering ad spending with cheaper marketing platforms such as branded websites and social media.

Digital spending is on the rise -- eMarketer estimated that health-care and pharma companies spent $1.03 billion on internet ads last year, up 13.9% from 2009 -- but drug makers are inhibited from doing more by a lack of guidance for social media.

In a notice in the Federal Register, the FDA said it would conduct three concurrent studies in order to assess how current advertising rules governing print, radio and TV ads will apply to social media. Specifically, how do drug companies portray accurate and complete "fair balance" -- the risk and benefit information -- in a Facebook post or a 140-character tweet?

Though these studies and this new comment period that ends June 27 are separate from the agency's November 2009 hearing and public comment period on social media, the FDA said in its notice that the new study "will complement qualitative research we plan to conduct on issues surrounding social media."

Translation? Those social-media guidelines the FDA said it would deliver in 2010, and then put off until the first quarter of 2011, and are still nowhere to be seen six weeks into the second quarter. And they are still a long way off.

"This [new study] is completely different and it's completely irrelevant. This is just the FDA continuing to try to solicit input on what elements of advertising influence people in different ways," said Peter Pitts, former FDA associate commissioner and now the president of the Center for Medicine in the Public Interest. "What it's showing is just how behind the curve the agency really is ."

The FDA admits the problem, saying in its notice in the Federal Register that , "The original regulations that presently determine FDA's position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast, and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to support guidance development."

There is , by and large, almost complete agreement in that assessment from all parties concerned. Now comes the waiting.

"To be candid, if you look at FDA historically, this is typical for them. FDA is loath to move quickly unless it involves product liability, like if someone is about to be poisoned by bad food," said longtime health-care agency executive Mike Guarini, the president of Connecticut-based Ryan TrueHealth. "Putting in social-media guidelines has become a joke. They don't know when they're going to do it, and neither does anybody else."

Asked if the delay is hurting business, Mr. Guarini said "Absolutely. No question about it. What I hear from clients and prospective clients is 'I want to do more in social media, but I don't know if it's good, bad or even legal.' The industry would just like some guidelines."

When that will be, however, remains to be seen. The FDA offered no timetable, saying only in its notice that "The series of studies described in this notice will provide data that , along with other input and considerations, will inform the development of future guidance."

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