Social Media Offer Many Benefits To Companies, But Caution Is Urged

Full article reprinted from "The Gray Sheet" - September 28, 2009

Social media sites like Facebook and Twitter can serve as an invaluable marketing resource for medical device and drug companies, but as FDA works to develop guidance on the issue, companies should be careful to control the content of their Web postings, marketing experts caution. Read more...

Social Media Offer Many Benefits To Companies, But Caution Is Urged

Full article reprinted from "The Gray Sheet" - September 28, 2009

Social media sites like Facebook and Twitter can serve as an invaluable marketing resource for medical device and drug companies, but as FDA works to develop guidance on the issue, companies should be careful to control the content of their Web postings, marketing experts caution.

FDA recently announced that it will hold a public hearing in November to help guide regulation of Internet and social media promotions for devices, drugs and biologics (The Gray Sheet' Sept. 21, 2009).

Alex Vandevere, digital strategy leader at marketing communications firm Global Prairie, classified social media along three general lines: user-generated content such as that found on YouTube and Wikipedia; bookmarking and sharing to allow online consumers to get the specific information they want; and social networking sites like MySpace, Facebook and LinkedIn.

Speaking at the Food and Drug Law Institute Advertising and Promotion Conference in Washington, D.C., on Sept. 21, Vandevere estimated that 60% of adults now have some sort of social media profile.

"If Facebook were a country, it would be the fourth most populated country in the world," Vandevere noted.

Consumers are using social media to "tap into a human need to share and connect, to get instant access to relevant information, to develop systems of support and to get a second opinion," he said.

Health care companies are leveraging this pool of potential customers with Facebook groups that provide information on specific medical conditions. For instance, drug company McNeil Pediatrics has a one-way outpost on Facebook for attention deficit hyperactivity disorder that has now attracted between 8,000 and 10,000 fans, Vandevere noted.

Health care communities like PatientsLikeMe and DailyStrength that are specifically set up to allow health care patients with specific diseases to post updates on their health, can also provide a wealth of information to medical companies, he said.

Further, companies can gain insight into what consumers are saying about them and their products through "microblogging" sites like Twitter, which might include posts about a firm's brand or reputation, Vandevere noted.

Patient blogs and postings are "still very influential in terms of decision making, probably still the number-one force for analyzing consumer sentiment," Vandevere noted.

FDA Oversight Of Online Ads And Promotion

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, noted that because much of the health information found online can cause more harm than good, FDA is attempting to clamp down on online promotion that does not present appropriate risk information.

However, "The problem with the Internet is it's kind of like Whack-a-Mole," she said. "All you need to do is get a new name and appear somewhere else and you're back in business."

The agency tries to go after the most egregious offenders, for instance disseminators of information so inaccurate it could kill people, Woodcock said. "However, all we can really do is shut them down, and in Internet terms that doesn't mean a whole lot," she said.

Ellen Rosenberg, VP-senior legal counsel at Shire Pharmaceuticals, observed that the questions FDA is asking regarding its development of guidance on Internet and social media promotions reflect the tension between the immediacy of social media and the slow vetting and reviewing entailed in traditional regulatory approaches.

Among those questions is whether companies are accountable for sponsored sites, third-party sites and/or unauthorized use of posted material.

"For example, if you issue a press release and you know that there are certain very influential blogs out there in your disease area, are you OK to send your press release to those blogs?" Rosenberg asked.

"And if so, what if they start commenting on it? What if there's misinformation? How are you going to address that? Can you respond to inaccuracies without becoming responsible for the whole site?"

Other issues that need to be worked out are the appropriate use of links, and how companies can fulfill risk communication requirements given the space limitations of social media, she said.

Recognizing And Mitigating Risks

Mark DeWyngaert, managing director of the Huron Consulting Group, classified social media into high-, medium-, and low-risk categories.

Companies expose themselves to the highest levels of risk when they sponsor social media sites where visitors are not controlled and may leave posts about off-label product uses, he said. For example, companies run high risks when they develop corporate disease awareness social networks, bulletin boards or branded corporate wikis (Web sites that allow easy creation and editing of interlinked Web pages).

Branded participation in social media, such as leaving posts or comments in forums, is also a high-risk activity, DeWyngaert said.

Medium-risk activities, according to DeWyngaert, include advertising on social media platforms, which presents some risk of off-label perception; maintaining non-branded disease awareness blogs; and maintaining branded blogs.

Lower-risk activities include branded corporate podcasting and non-branded advertising on a social media platform, he said.

To mitigate risks, DeWyngaert suggested companies create "what if" scenarios for discussion with legal and compliance staff in order to come up with clear written guidelines for adverse event reporting, employee conduct on company-sponsored sites and presentation of user-generated content.

Companies should also discourage the use of any personally identifiable patient information on social media and should set strict guidelines on use of information gathered from social media sites, particularly for sales or marketing purposes, he recommended.

Get sneak peak inside this report with a preview of A Conversation With SAGES President, C. Daniel Smith, MD. Smith discusses trends in minimally invasive surgery and the single-incision laparoscopic approach.

Get this article and many more! Click here to download a complimentary copy of the current issue of “The Gray Sheet” when you sign up for a 30-day, risk-free trial.

To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Sean Smith at 240-221-4535 or [email protected].