Pharmaceutical Firms Tackle Proposed FDA Social Media Guidelines
Trade groups and drug giants alike have raised significant concerns about proposed social media compliance guidelines from the Food and Drug Administration. The industry says they could have a chilling effect and lead to reporting headaches.
Think it’s hard to deal with all the sensitivities of social media? Try working for the drug industry.
The Food and Drug Administration, which sets requirements for marketing pharmaceuticals, is in the midst of finalizing guidance on “interactive promotional media.” But its proposal has received anything but a warm welcome from drug companies and trade groups such as the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO).
The groups have raised significant questions about how the social media guidelines would affect advertising, content outside of the manufacturers’ control, employee conduct, and even interaction with the public online.
About the Guidance
The FDA’s draft guidance [PDF], released in January after a four-year planning period, highlights a challenge for drug regulators: How do you regulate the messaging about a drug in a 140-character world, especially working within the confines of a law that predates social media by decades?
FDA’s proposed solution, among other things, includes heavy reporting requirements, including keeping the agency informed of where a company is publishing—both on websites it owns and on third-party outlets, such as social networks. This list would be thorough and would include URLs linking to individual pages, static websites, and annotations marking real-time interactive content.
But the FDA readily admits that the standards of the Federal Food, Drug, and Cosmetic Act, passed in the 1930s but later amended, may not match the realities of real-time communication.
“However, for some interactive promotional media, submission ‘at the time of initial dissemination’ may pose a challenge for firms, particularly when these media communicate information that is displayed in real time,” the agency’s draft guidance states.
Possible Side Effects?
During the comment period, which ended last week, PhRMA, BIO, and a number of their members raised concerns about the guidance—particularly regarding the reporting standards and potential free-speech implications.
“Given the extraordinary growth of the internet as a source of health information—and the enormous amount of inaccurate and non-regulated information about medical products online,” PhRMA stated, “FDA should avoid chilling manufacturers’ responsible communication of medical information about their products and should allow manufacturers to take advantage of the same technologies that FDA and the White House use, including blogs, video, search, and social networking sites such as Twitter.”
PhRMA expressed concern about the broad scope of the reporting standards: “The draft guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the draft guidance could chill truthful and non-misleading communication protected by the First Amendment.”
BIO, meanwhile, suggested that the broad scope of the guidelines could make it difficult for a manufacturer to correct misinformation about its products online and suggested that the rules should allow drug companies to interact with user-generated content.
The respondents weren’t limited to pharmaceutical firms. The Social Media Compliance Council, a group focused on developing proper social media protocol for regulated industries, raised a series of questions highlighting potential oversights in the proposal. It suggested that, whenever a standard is finalized, “consistency and parallel guidance is provided” with outside groups that may be affected by the standard, such as Canada’s Pharmaceutical Advertising Advisory Board, the Association of the British Pharmaceutical Industry, and the U.S. Federal Trade Commission.
Other organizations that offered comments on the draft guidance include the Coalition for Healthcare Communication, Pfizer, Novartis, and Eli Lilly and Co.