Regulatory Concerns Hamper Pharmas’ Use of Digital Media

Companies Rank Off-Label Communication as Leading Digital Marketing Concern, according to Cutting Edge Information

Regulatory Concerns Hamper Pharmas’ Use of Digital Media

Cutting Edge InformationCassie Demeter, 919-403-6583

Part of drug companies’ reluctance to dive into digital marketing stems from the lack of regulatory guidance, according to a benchmarking study by Cutting Edge Information.

The study, “ and Social Media,” asked to rank challenges to digital marketing efforts, surveyed pharmaceutical companies ranked FDA-related issues high. An average among surveyed pharmaceutical companies rated -based concerns at an average 7.4 out of 10. Surveyed companies rated lack of FDA regulations as a 6.8. All told, lack of regulatory guidance represented the top three concerns expressed by surveyed companies.

Many pharma companies are wary of social media, primarily due to the two-way dialogues and lack of company control in public forums. The FDA somewhat alleviated this concern by publishing a draft of digital guidance in December 2011. The regulation, while vague, provides some guidelines when dealing with company-based social media interaction.

The FDA still leaves room for company discretion when dealing with off-label concerns. It is these grey areas that are the most challenging for drug companies. The study’s data show that 79% of surveyed companies’ marketing strategies are affected in some way due to the lack of social media guidance.

Avoiding the hefty fines that often accompany off-label promotion means that drug companies must post information concerning formal usage policies on their websites. “‘One click away’ disclaimers are not enough to protect companies when they present promotional information using a digital format,” said Eric Bolesh, director of operations at Cutting Edge Information. When navigating uncertain regulatory waters, companies also benefit from a strong digital strategy. Applying a top-down digital model gives companies the freedom to adapt their in the wake of an uncertain regulatory environment.

“Pharmaceutical Digital Marketing and Social Media” () is designed to help marketing teams:

For more information on digital marketing, social media, and pharmaceutical marketing strategy, visit

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