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Sep 27, 2016

Tweet This — If You Want to be Slapped with an FDA Warning Letter

These do's and don'ts will help you
 engage with customers compliantly.


 by Lisa Weeks

 Marketing Communications,      MasterControl



Is the FDA starting to get serious about how medical devices and prescription drugs are being marketed on social media? Many experts think so, citing Kim Kardashian’s highly publicized misleading endorsement of the morning-sickness medication Diclegis® as an example. The offending post, which appeared on the reality star’s personal Instagram page, earned drug maker Duchésnay a warning letter, demanding an immediate retraction. The post was promptly removed—after it had garnered 450,000 likes from Kardashian’s over 42 million followers. 



OMG. Have You Heard About This?


“OMG. Have you heard about this?” Kardashian asks, striking one of her trademark come-hither selfie poses. She then proceeds to tell her fans about the terrible nausea she has been experiencing during her second pregnancy and credits Diclegis®, the only FDA-approved prescription treatment for morning sickness, with making her feel “a lot better…with no increased risk to the baby.” What she failed to mention were the drug’s potential side effects and interactions, omissions which violate the FDA’s drug-promotion rules. (Get the full Kardashian / Diclegis® story.)
As Kardashian / Diclegis incident shows, social media’s rapid, casual communication style represents both possibility and liability for the life sciences industry, which has been slower to add it to its marketing mix than other industries. This is not surprising since drug and device companies face unique regulatory challenges.




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Who’s Using It—and How?


In many ways, life sciences companies have mirrored the FDA by taking slow, incremental steps toward social utilization. It was not until 2014 that the agency provided some clarity on how to compliantly engage with consumers and caregivers on social platforms. Many felt it was not enough, and the FDA admits that its social media policy is still evolving. Its biggest concern appears to be ensuring that social media platforms are not used to promote off-label use of devices and drugs.

While some medical device manufacturers have embraced social media, the vast majority have shied away, unsure of the regulatory parameters or the return on investment of social media engagement. Pharmaceutical companies have been slightly more engaged socially than device makers, but they, too, have a long way to go. According to a study by the IMS Institute for Healthcare Informatics, only half of the top 50 pharmaceutical companies in the United States are discussing product claim conversions with patients and caregivers on social platforms.1

Is the FDA’s Social Media Policy Impractical?


Given the character space limits on most social platforms (e.g., 140 character maximum on Twitter), critics of the FDA’s social media policy are suggesting it is unlikely any drug or device could be promoted to the FDA’s satisfaction on social media. Which begs the question: Are the FDA’s social media disclosure and compliance requirements impractical?2

To date, the FDA has released four social media-related draft guidances:

  • Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014), which addresses how to present balanced product benefit/risk information given the character and limitations of online microblog messaging platforms (e.g., Twitter), as well as online paid search, e.g., “sponsored links” on search engines such as Google and Yahoo.
  • Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (June 2014), which offers guidance on how to respond to product-related misinformation created or spread by third-parties (i.e., user-generated content) on the Internet or through social media.
  • Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (December 2011), which updates and clarifies the FDA’s policies on unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information) pertaining to FDA-approved or cleared products, including requests received through emerging electronic media.
  • Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (January, 2014), which explains how the FDA defines interactive promotional media and how to determine if the product your promoting is subject to the FDA’s postmarketing submissions requirements.

A thorough examination of these individual guidances is beyond the scope of this piece, but some key takeaways are highlighted below. More information can be found on the FDA’s social media guidances web page. It is also important to note that other agencies and organizations, such as the Federal Trade Commission (FTC) and Google, impose their own regulations for producing compensated content for digital advertising and social channels.


4 Tips for Using Social Media Compliantly


#1. Include the good (benefits) and the bad (risks). 

When promoting a drug or device socially, the manufacturer should discuss the product brand name, on-label benefits and potential side effects within the same character-space-limited communication, i.e., each message or tweet. Companies should also include a direct hyperlink to the “Important Safety Information” web page (within the product website) that is devoted to providing comprehensive risk information about the device. If a given platform cannot accommodate this level of transparency, the FDA recommends using a different social platform or medium (e.g., blog posts).3 


#2 . Establish best practices. 


Correcting misinformation posted on truly independent third-party websites is voluntary. If a company elects to respond, but is limited by character restrictions, a best practice is to direct the customer to the department (or individual) best suited to provide a compliant, balanced risk/benefit response, or to a web page which offers complete disclosure information (e.g., package insert, labeling information) that has already been FDA approved. It is important to keep the response simple, and avoid using promotional URLs, e.g., info@bestpregnancytest.com.4

#3. Don't cherry-pick. 


If a company opts to correct misinformation that appears online, cherry-picking is not allowed. The FDA provides a good example of what it considers to be cherry-picking: “A manufacturer decides to correct misinformation posted on a blog that allows comments. The firm corrects misinformation in several blog postings that provide incorrect risk information associated with the product and makes clear it is only correcting those pieces of misinformation, but the firm does not address exaggerated efficacy claims in favor of the firm’s product in other postings that appear to readers between the postings it is correcting. Even if the firm corrects the misinformation in the limited posts it chose, the firm’s actions are not in accord with the guidance because it has intentionally selected only negative information about its product to correct.”5

#4. Avoid “Liking” comments about off-label use.


Many drugs and devices have off-label uses that benefit patients. The FDA has a very formal process for managing off-label information, and similar rules apply to social media. If a manufacturer encounters a public, unsolicited request for off-label information about a device made through social media, the FDA offers four recommendations:6
  • Only respond when the request pertains to the manufacturer’s own named product and is not solely about a competitor’s product.

          Example 1a: “Can Device X be used for Condition Y?” Okay to respond, specific to                                                             Device X.


          Example 1b: “What device can be used to treat Condition Y?” Not okay to respond,                                                             not specific to Device X.

  • Limit the response to providing the manufacturer’s contact information; do not include off-label information. This will allow the individual to obtain off-label information directly from the manufacturer. The off-label information provided to the individual should not be made public within the forum in which it originated.
  • The manufacturer’s representative who responds to the legitimate public request (as described in example 1a) should disclose his/her involvement with the manufacturer in his/her response.
  • Public responses to public unsolicited requests for off-label information should not be promotional in nature or tone. For example, a public online response should include a hyperlink to the current FDA-required labeling, if any, and not include hyperlinks to the product website or other promotional sites.

There are gray areas. For example, a manufacturer received a warning letter for “liking” a favorable comment a Facebook user made about a benefit he or she received from the using one of its products. While this seems innocuous, the FDA interpreted it as an endorsement of off-label use of the device, although the draft guidance does not clarify whether “liking” or “re-tweeting” someone else’s post is considered promotional.

Social Media as a Competitive Advantage 


Despite the restrictions and somewhat vague FDA guidelines, drug and device companies that shy away from social media are missing out on valuable opportunities. Research shows that almost three-quarters of U.S. adults have searched online for health care information, a number which is rising rapidly as seniors become more familiar with technology and the Internet. What’s more, 58 percent of physicians perceive social media to be an effective way to access current, high-quality information, according to the Journal of Medical Research.7
For this reason alone, it is vital for device makers to develop and maintain a strong social presence; even a passive presence will generate value.

A passive social media strategy, based on monitoring social platforms for customer and patient feedback, carries little risk and no need for adverse event reporting.8 An aggressive strategy, in which the manufacturer actively engages with consumers online to generate brand and product awareness, is riskier but yields higher rewards. Manufacturers that opt for the latter must develop a system for adverse event reporting to ensure fair balance.

Bottom Line


Since only a minority of medical device and pharma organizations currently have a well-developed social media presence, working to increase development may create a significant competitive advantage for drug and device companies that are willing to become early adopters. 

If your company is using social media to engage with customers and healthcare professionals, tell me how—leave a comment below.



Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med. Her work has appeared in numerous industry publications, including Medical Product Manufacturing NEWS (MPMN)Medtech Pulse, Risk Insights, MD+DI, Pharmaceutical Processing, Genetic Engineering & Biotechnology News (GEN) and PharmaTech. 


References:
1 Carr, David F., “IMS Health: Pharma Companies Should Engage on Social Media,” January 21, 2014. http://www.informationweek.com/healthcare/policy-and-regulation/ims-health-pharma-companies-should-engage-on-social-media/d/d-id/1113505
2 Butler, Alex, “OMG! The FDA is Keeping Up with Kim Kardashian, Too,” August 28, 2015. http://mastercontrolinc.blogspot.com/2015/08/omg-fda-is-keeping-up-with-kim.html
3 U.S. Food and Drug Administration, “Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,” June 2014. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf
4 U.S. Food and Drug Administration, “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” June 2014. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401079.pdf
5 U.S. Food and Drug Administration, “Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices,” June 2014. Page 7.  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401079.pdf
6 U.S. Food and Drug Administration, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” December 2011. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf
7 “Social Media Benefits for Medical Device Companies.” Retrieved from http://www.mrchouston.com/social-media-benefits-medical-device-companies/
8 “Why Healthcare Can’t Afford to Ignore Social Media.” Retrieved from http://www.mdgadvertising.com/blog/why-healthcare-cant-afford-to-ignore-social-media/




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