The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the global centers of life sciences regulations, including the United States, the European Union (both the unified government and the individual countries), Brazil, Mexico, China, Japan, and other regions. Conference topics centered predominantly on international themes, such as the European Union Medical Device Regulation, China’s drug and medical device regulations, international implementation of the Medical Device Single Audit Program, and international implementation of social media promotion regulations.
International Regulation of Social Media Drug and Medical Device Promotions
I attended the conference as a speaker and moderator of a panel on international regulation of social media promotions by life sciences companies. Although I regularly track and write about FDA’s regulations and guidance related to social media promotion, this panel offered a unique opportunity to broaden my perspective to the international challenges of dealing with the regulation of open, global communications platforms that could carry promotional messages about drugs, medical devices, and other regulated products. Panelists included Brenda Gonzalez Morales, Executive Director of Marketing for COFEPRIS (Mexico’s public health regulatory agency), and Andrea Chamblee, Associate Professor at the George Washington School of Medicine and Health Sciences. Our individual presentations focused on the attempts of various countries/regions, namely the United States, Mexico, and the European Union, to regulate social media promotions, and some of the obstacles preventing consistent enforcement:
- FDA released three guidance documents in 2014 on social media promotion, and the Agency continues to issue Warning and Untitled Letters to companies whose promotions on Internet platforms violate labeling regulations. While FDA has continued enforcement actions of basic promotion and labeling requirements (e.g., inclusion of risk information in social media promotions), the Agency has issued few Warning Letters related to unique social media functions, such as the ability of companies and consumers to “like,” “retweet,” or share posts.
- Mexico, like other countries, has seen a sharp rise in social media use compared to traditional media, such as television, and COFEPRIS has applied its legislation and regulations to protecting the public from misleading social media promotions. Although COFEPRIS requires life sciences companies to obtain approval from COFEPRIS for all promotional materials, Ms. Gonzalez Morales stated that requiring companies to submit applications for social media promotions and scouring the Internet for violators is an impractical system.
- The European Union, as a whole, has not enacted any legislation, regulation, or requirement related to social media promotion of regulated products, which leaves such regulation to the individual member states. Some European life sciences industry associations have released best practices documents on social media promotion, but the majority of these guidelines recommend very limited use of social media.
The panelists emphasized the difficulty of imposing regulatory standards when a company in one part of the world can post promotional material online that can be accessed by potential consumers all over the world, even in regions where such advertising may be prohibited. Specifically, the panel noted that the United States, unlike almost all other countries, allows direct-to-consumer drug, device, and biologic advertising. While websites that direct consumers to select their country of residence to direct them to specific landing pages with country-appropriate information, such measures cannot always be used to limit the information available through open social media platforms.
Possibility of International Alignment on Social Media Promotions
Given the current international efforts towards harmonization of regulatory standards, is there room for discussions on international alignment of standards governing social media or Internet promotions of regulated products? It's possible. However, any consideration of international standards for Internet promotion of regulated products will likely have to wait until current harmonization efforts on standards for manufacturer registration and inspection, as well as product specifications and approval criteria, reach some form of accord. In the meantime, it seems clear that piecemeal and inconsistent regulation of drug, device, and biologic promotion on social media platforms will continue, both in specific regions and on a global scale.