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The New Promotional Rules: “There Are No New Promotional Rules:"

There is resounding evidence that physicians and patients rely on the Internet—including social medial platforms—to research and communicate health information. The FDA, however, has been slow to adapt even though the potential benefits to patients are great. In line with requirements set by the Food and Drug Administration Safety and Innovation Act, 2014 was supposed to be the year manufacturers finally got clear direction through the regulatory minefield of online promotion. The three draft guidances released to date fall short of expectations and give Industry little support in its efforts to keep up with communication strategies of the patients and healthcare practitioners who use its products.

This white paper examines the shortcomings of three draft guidances released to date in the context of drug and device manufacturers’ and consumers’ expanding use of digital and social media. Rather than trying to make old regulations keep working in a new era, the authors make the case that balanced, risk-based regulation of industry’s digital media use can facilitate medical advancement while preserving patient safety.