FDA social media guidelines: Access denied in most cases

accessdenied-375x250POST SUMMARY: The question of how pharma companies can meet fair balance requirements in character-limited formats has been a major barrier to the use of social media. The FDA is saying that the channel isn’t suited to complex and high-risk products.  This guidance is a clear indication that the FDA does not understand how consumers are making healthcare decisions and it will prohibit a lot of pharma companies from really leveraging social media to help patients find relevant information online.

“Lipitor can help lower cholesterol and reduce CV risks”, “Cialis can help men be rady for intimate moments”.  Is there anyone who believes that Tweet’s, such as these, are really going to lead to someone asking for an Rx?  The reality is that patients are NOT going to take a Tweet ot text message to heart without doing more research online.  So why would the FDA require fair balance?  Because they are dinosaurs.


According to Manhattan Research;

The agency is clear that where marketers make a product benefit claim – including what the product is indicated for – they must also provide risk information within the same Tweet or sponsored link. That risk information may, in acknowledgement of space constraints, be limited to only the most serious risks – those that are fatal or life-threatening, boxed warning basics, contraindications and risks to handlers, or simply the most serious warnings and precautions – provided that the marketer provides “a mechanism to allow direct access to a more complete discussion of the risks associated with its product.

According to IMS

  • Twenty-three of the top 50 global pharmaceutical manufacturers have some level of healthcare-related social media engagement. . The overall level of engagement between pharmaceutical companies and patients has steadily increased during the past year as more organizations become active in this area. But the real question is: is it relevant? 
  • Regulatory agencies are active in social media. Regulators increasingly are utilizing social media channels to connect to a wider healthcare audience. The U.S. Food & Drug Administration (FDA), which has a particularly strong Facebook presence, ranks highly on social media engagement and has a higher relationship score on the IMS Health Index than any pharmaceutical company.
  • Wikipedia is the single leading source of medical information for patients and healthcare professionals. The top 100 English Wikipedia pages for healthcare topics were accessed, on average, 1.9 million times during the past year. Rarer diseases, which often have fewer available information sources and are less understood by patients and clinicians, show a higher frequency of visits than many more common diseases. In an assessment of 50 major disease-specific Wikipedia articles, the Institute found a strong correlation between page views and medicine use, with online information-gathering occurring throughout the patient journey. Content incorporated or updated on healthcare-related Wikipedia pages is subject to constant change, often overseen by informal or formal working groups. An assessment of Wikipedia disease articles indicates that at least half of the changes made are related to patient-relevant information.
  • Social media engagement lags significantly within the population segment that uses healthcare services the most. Age is one of a few differentiating factors in the use of social networking sites, where utilization is less dependent on gender, education, income or other forms of social advantage. Younger people tend to conduct online investigations before the start of therapy, as measured by prescriptions or sales of medications. By contrast, patients age 50 or older tend to begin their treatments prior to seeking information online. The difference of utilization by age groups will diminish as “digital natives” increase their involvement and influence professionally and privately within their networks.

While there are some pharma organizations that are likely to embrace the social media guidelines from the FDA there are surely too many risk adverse companies that are going to put a do not enter sign on social media.  The FDA has done nothing to help eliminate the confusion of health information or to ensure that health information on sites like Wikipedia are accurate.  Take three steps back.


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