While the Securities and Exchange Commission this week added some clarification to how companies can use social media networks, pharmaceutical companies are still waiting on something, anything, of that nature from the Food and Drug Administration.
While some pharma companies, like Boehringer Ingelheim and Sanofi-Aventis, have embraced the opportunity to push the non-existent boundaries, the fear of wading into uncharted territory without a compass has kept some medical companies away from online channels where patients are gathering. But that fear may not be as grounded as previously thought, according to a new white paper.
Mark Senak, a senior vice president and partner at Fleishman Hillard International Communication who blogs at Eye on FDA, published an analysis of FDA notice of violation and warning letters that suggests the agency is taking relatively little action against pharmas’ online activities.
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In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
In a new whitepaper (PDF), he looked at four years’ worth of warning letters and notice of violation letters issued by the FDA’s Office of Prescription Drug Promotion to pharmaceutical companies regarding their communication about medical products. He wanted to see how many of them cited violations on digital and social media platforms vs. non-digital platforms.
Focusing on the years 2008 to 2012, when he says social media really started to take off for brands, he found that OPDP issued 173 regulatory action letters to pharmaceutical and biotech companies regarding communications about their products. As each letter usually addressed multiple violations across various channels, he counted 236 different communication vehicles and 675 separate violations.
About 43 percent of those 675 violations involved digital media channels, versus 57 percent that were distributed via traditional media. And of the 173 letters, only one specifically cited a social media platform as the basis of the letter (the one issued to Novartis’ about its Facebook share widget in 2010).
In fact, Senak writes, warning letters were issue three times more often for communications via traditional media than digital media, and the number of warning letters issued against digital media vehicles has actually declined – as has the number of letters issued for communications violations overall – since 2009.
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A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Since we don’t know how much of the pharmaceutical’s consumer communications efforts are digital vs. non-digital, it’s hard to draw any definite conclusions, but according to Senak, “the lack of clarity respecting the rules around Internet and social media use does not appear to translate into a greater pattern of enforcement against digital media.”
John Mack over at Pharma Marketing Blog has a different take on the data. He notes that Nielsen data has suggested that only 2 percent of pharma’s direct-to-consumer budget is used for digital communication, so the 43 percent of violations referencing digital platforms is indeed an over-representation.
FDA data on the number of internet/non-internet-based advertisements and promotional labeling for drugs and biologics it received for review in 2011 suggests the same, he says: “The lack of clarity respecting the rules around Internet and social media use by pharma DOES appear to translate into a GREATER pattern of enforcement against digital media.”
What do you think?
