Delay on FDA Social Media guidance is no surprise

I’m sure you’ve had plenty of times in life when you feigned shock upon being delivered bad news, usually to make the point that someone or something lived down to your expectations. That pretty much describes my reaction to this news item.

Yes, the FDA will indeed NOT be releasing its long-anticipated social media guidance for pharmaceutical companies this year, as it had said it would do for months.  It is now saying it hopes to release a guidance in the first quarter of 2011.

The FDA’s Division of Drug Advertising, Marketing and Communications (DDMAC) issued the following statement via email (credit to Mark Senak’s Eye on the FDA blog):

“The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:

  • Responding to unsolicited requests
  • Fulfilling regulatory requirements when using tools associated with space limitations
  • Fulfilling post-marketing submission requirements
  • On-line communications for which manufacturers, packers, or distributors are accountable
  • Use of links on the Internet
  • Correcting misinformation

“Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.”

The FDA has been “researching” this matter since March 2009 – almost two years. It had a two-day public hearing on the matter in November 2009 – 13 months ago. Now we’re at the end of 2010 and still no guidance.

Government bureaucracy at its finest. Accountable to no one. And as the only show in town, no alternatives for the customer to turn to. Surprising? The only surprise here is that the FDA even bothered to issue a statement on it.

Pharma is slowly starting to embrace social media. But the key is slowly, because of all the regulations involved. And while pharma (and healthcare in general) is not like other industries, pharma consumers are still taking to “the groundswell,” and pharma needs to be there as well. A thorough, well-developed guidance would help make pharma companies more comfortable doing so.

Then again, I’m not expecting much from this guidance either – whenever (or if?) it comes out. Again, it’s the federal government, and a particularly powerful agency at that. Powerful government agencies don’t tend to produce anything that might chip away at its power. And government bureaucracies tend not to produce anything that is clear, precise and easy to understand.

Simply put, I’m anything but surprised that the FDA’s “guidance” won’t be out this year. And I’ll be only slightly less surprised if the final product turns out to be worth the wait.

 

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