Over 800 people registered for only 350 available seats at the “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media’ hearing on Nov. 12 and 13. It seemed everyone wanted a front-row seat as trade groups (PhRMA and AdvaMed), internet giants (Google, Yahoo, WebMD), Big Pharma companies (Lilly, Pfizer, J&J) and assorted ad agencies and bloggers pleaded their case for FDA to issue formal guidance on pharmaceutical marketing practices via social media.
The two-day hearing was streaming live on FDA’s website and even a “hash-tagged” group (#FDASM) followed coverage on Twitter. However, as eyeonfda.com blogger Mark Senak reported, the irony of the social media hearing was the absolute lack of Internet access in the meeting room and refusal of press access. So much for FDA transparency.
The theme of all the presentations remained the same: FDA cannot continue to ignore the influence of the Internet if it wants to effectively protect and promote the public health.
This past March, FDA sent letters to 14 pharmaceutical companies telling them that their search ads needed to include drug risk information in the text of the ads, causing marketers to pull these ads and become more cautious about their web promotion.
Eli Lilly, who received one of these warning letters, commented in the hearing that because of FDA’s lack of guidance the company has had to adopt a “better safe than sorry” attitude towards discussing its products online, giving other less-adherent companies an advantage in their online marketing efforts. PhRMA’s presentation suggested placing an FDA logo within advertisements that would link viewers to the drug's full risk information. The abbreviated text would let manufacturers send short messages about their drugs on social media sites like Twitter and Facebook.
Google’s presentation asked that FDA create a standard template for web ads, which might include links to both benefits and risk information within the context of the ad, so that there is balance. They also had a mock version for products with black box warnings.
Yahoo spoke of the novelty of Web-based advertisement, suggesting that FDA draft guidelines that would allow drug companies a greater degree of flexibility.
While some pleaded their case for clear-cut direction, others offered specific examples to be included in a proposed guideline.
Pfizer, for example, documented its recent success with Sermo.com, a social media site recently created as a means to interact directly with doctors around the world, and urged FDA to allow for more open social interaction between Big Pharma and the public.
Diana Zuckerman of the National Research Center for Women & Families suggested FDA "partner" with Wikipedia and various popular drug information sites to ensure that its content is transparent and accurate.
Online pharmaceutical-marketing expert John Mack, of Pharma Marketing News, recommended that FDA require drug manufacturers to put an FDA-designated hash tag on their Twitter posts in order to efficiently monitor and censor discussion regarding products.
As the two-day hearing came to a close, Tom Abrams, director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), said, “FDA wants to give this much thought as we determine the best approach to the Internet and social media tools. FDA has much work to do in this area.”
The question now remains . . . when exactly will FDA do this work?