The FDA recommends that pharma shall adopt a very limited policy when it comes to requests that come through channels such as social media sites.

“A firm’s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm’s contact information and should not include any off-label information.”

Any substantive communication about off-label uses for the product, in response to the original unsolicited off -label question, should occur solely between the firm and the individual who made the request.

“Regardless of the fact that the original, unsolicited off-label question may have been available to a very broad audience, the firm should not make its detailed response with off-label information publicly available within the same forum.”

The FDA is concerned that firms may post detailed public responses to questions about off-label uses of their products in a way that are communicating unapproved information to those who have not asked for it. The FDA recommends that firms only respond to public requests that pertain specifically to its own named product.

Read the full Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices

Or a wrap-up on the Digital Intelligence Blog

For many biotech companies LinkedIn is the “neighborhood of choice”. According to Mari Serebrov, author of ‘Many Biotechs Shying Away from Social Media World’, 71% are on LinkedIn, 56% are on Facebook and 48% tweet. When asked which site worked best for them, 61% said LinkedIn, 23% cited Twitter, followed by 20% for Facebook.

The survey revealed that there is great uncertainty among biotechs on how best to use social media to advance business. So the question is how can biotech companies make use of social media?

How can biotech firms make use of social media
Social media is about connecting with people. For businesses this means connecting with target audiences. So why not integrate social media in all external communications? Every newsletter, direct mailing or press release can be tweeted or posted on LinkedIn! Especially for press releases, there are services such as B3C newswire available that post news to Twitter and LinkedIn.

I think that it is crucial that companies serve all those channels for communications that are potentially used by their customers or target groups. To these channels belong the company website, RSS, newsletter and – increasingly social media. There are people who rely on RSS and those that prefer Twitter or LinkedIn. So why not use social media as an additional channel to get the word out?

But as long as the FDA does not provide formal guidance many biotechs will probably stay antisocial and so miss the opportunity to appeal to new audiences.

AstraZeneca developed five principles on how FDA should regulate social media communications:

Ensure Truth and Accuracy: Any content created, developed, or made available by product sponsors should be truthful, balanced, accurate and not misleading.

Be Respectful: Product sponsor should respect the interests of patients, caregivers and health care providers, particularly related to matters of privacy and the primacy of the patient/physician relationships.

Protect and Advance Patient Health: Guidance should facilitate patient access to quality information to improve their health. Also, guidance should protect patients through encouraging accurate and timely reporting on medicine safety.

Be Transparent: Any product-sponsored participation should be accomplished in a manner that, at all times, is entirely transparent to other participants about the product sponsor‘s role in the online discussion.

Respect the Views of Others: Guidance should respect that patients, caregivers, clinicians and others who participate in social media have their own opinions and that, when they differ from those of the product sponsor, it is not the role of a product sponsor to censor or limit these views but to add the product sponsor‘s own views to the discussion.

Just saw the Pharma Marketing Blog post:
“Tom Abrams, the Head of FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), apparently believes Twitter and YouTube are passing fads. During his presentation at the just-concluded ePharma Summit in NYC, Abrams said FDA would NOT do guidance on specific technology platforms such as YouTube, Facebook, or Twitter…..Is It Time for Abrams to Leave?

If you look at the story of professional race-car driver Charlie Kimball diagnosed with diabetes and under contract with Novo Nordisk to help promote its insulin one can understand why the FDA is striving for a solution. There is no reason to assume that everybody, such as Kimball, adheres to the rules.

Wherever people use social media and are being paid for their comments, there should be guidance on what is allowed and what not. However, nobody will ever be able to regulate the hundreds of thousands of people who use social media to express themselves and exercise their right to freedom of speech.

The FDA has stringent guidelines on how drugs can be marketed in newspapers, magazines, and broadcast media. Basically, companies must disclose essential information about a drug’s known risks. But there are still no such regulations for social media and I wonder why it takes so long to adapt the existing rules.

“It really has reshaped and changed the way patients manage their health issues.”
Although the threat of misinformation is always out there ”trying to monitor all the chatter to weed out the good information from the bad was not only next to impossible, but also not a productive solution.”

Bob Brooks, WEGO Health vice president, cited a study “that had 64% of people saying they wanted pharmaceutical companies to monitor and correct misinformation about their products on the Internet, with 60% of that same group simultaneously saying such a task was unrealistic in its scope to be able for those companies to undertake effectively.”

“Doctors are pressed for time and patients have a harder time communicating with their health care providers about their treatment options — compelling them to turn to social media for answers.”

Read the full story

The story has been picked up by Bioworld Today on Oct 22, 2010.

Sure, this is only a vague estimation. But what we can say from fifteen biotech social media groups that we have followed over the past six months is, that the member counts increased from 150,000+ to over 250,000. In 2011, the number will most probably exceed 500,000. 

While biotech “consumers” more and more use social media, pharma and biotech companies are still hesitant.

For big pharma and biotechs, the problem seems to be the FDA and the regulatory risks associated with the new medium. But from the angle of PR distribution, is there really a regulatory risk when press releases are also made available to social media in addition to being just online? 

Social media provide new opportunities to engage customers, business partners, or other consumers. Therefore, biotech and pharma companies should use social media as a very efficient tool that helps them gain a competitive advantage, build relationships, and enhance reputations. Interestingly, Roche recently affirmed its commitment to social media as part of its communication policy. When will others follow?

Social media require constant monitoring and real-time engagement. Therefore, for smaller companies, start-ups and mid-size biotechs especially in the fields of drug discovery and development that have not yet a real client base, social media engagement is too time consuming to be worthwhile. For these companies, a service such as b3c newswire could be very useful to cost-effectively benefit from social media.