Open Access Social Media Guide for Pharma: FDA Weighs In? January 11, 2012

I was very happy to announce, a few weeks ago, the launch of the first open access social media guide for and about pharma and the feedback was amazing! John Mack from Pharma Marketing Blog analyzed it line by line. Then the FDA came out with a guideline-like paper mentioning social media as well.

“What everybody was looking for was never going to happen. If you’re waiting for divine guidance, you’re still waiting,” Peter Pitts, president of the Center for Medicine in the Public Interest, told Ad Age. “I doubt there is ever going to be definitive rules for social media-marketing like there are for TV and print. And there’s a reason for that. FDA has made it very clear they were not going to make platform-specific guidelines, like how to use Facebook, how to use Twitter, because social media evolves every day.”

- here’s the FDA’s guidance (.pdf)

I’m pretty sure it does not do what it should do and help pharma use social media properly. Two fellow bloggers tried to interpret this paper (one and two). As Dose of Digital said:

It’s been a long wait, but the FDA finally delivered. They’ve come through with at least some direction for how pharma companies can properly use social media. It’s not a complete answer to every issue, but it is a good start. I’ve reviewed the full contents of the guidance that the FDA released on December 30, 2011 and found it, not surprisingly, a bit hard to follow at times. The full title of the guidance they released is: “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” Catchy.

Then I wrote a letter to the FDA and the European Medicines Agency to get some feedback from them. EMA responded quickly:

“Dear Dr. Mesko,

Thank you for your email of 16 December 2011 regarding guidelines about using social media.

Please note that the European Medicines Agency (EMA) is a European scientific body responsible for the evaluation of medicines for authorisation purposes within the European Union and the supervision of their safety thereafter. Providing guidance to healthcare professionals and the pharmaceutical industry on using social media is not within the Agency’s remit.

You may find it useful to know that the European Commission adopted on 11 October 2011 two revised proposals clarifying the information that industry can supply to the public on prescription-only medicines. For more information please refer to the following webPage:

http://ec.europa.eu/health/human-use/information-to-patient/legislative-developments_en.htm

We hope you find this information useful.”

I replied to them saying that while the FDA is working on such a guidance, are they sure they are not doing something similar?  They replied again:

Thank you for your follow-up email of 3 January 2012 regarding guidelines about using social media.

We can confirm that the European Medicines Agency (EMA) is not developing any guidance for healthcare professionals and the pharmaceutical industry on using social media.

That’s it, my friends. The FDA came out with something but we expected much more; and the EMA is not even planning to deal with social media.

We are alone, but don’t worry. In a collaborative effort, we can create a detailed guide for us.

Open Access Social Media Guide for Pharma on Webicina.com! December 15, 2011

After months of hard, collaborative work, Webicina.com just published the first version of the open access guide for pharma about using social media. While drug companies, healthcare professionals and e-patients wait for FDA guidelines on social media, with an expert crowd (with special thanks to Dr. Felix Jackson from MedDigital), we created our own guidelines to serve as a basis for more detailed, extended guides.

You can download the PDF (14 pages) here! And see it on Slideshare:

Please feel free to download it, share it with your colleagues and join us to create an even more sophisticated second version which we can submit to the FDA. Give us feedback on Twitter through #pharmaSMguide!

The original Google Docs document contains more details, negative and positive social media-related pharma case studies as well.

Here are the Q&As about the project.