When pharmaceutical companies advertise online or via email and text messaging -- or by interacting in social media such as blogs, Facebook, or Twitter -- who’s making sure they’re adhering to the strict requirements the U.S. Food and Drug Administration imposes concerning any discussion of their regulated products?
The FDA held a two-day hearing earlier this month to discuss the thorny issue of how pharmaceutical companies should market their products online and in social media. The hearing was held in the National Transportation and Safety Board Conference Center in Washington and featured more than 60 15-minute presentations by representatives of big pharma, public interest groups, public relations firms, and Internet companies, including Google (Nasdaq: GOOG) and Yahoo Inc. (Nasdaq: YHOO).
A 12-member panel from the FDA’s division of drug marketing, advertising, and communications interacted with the speakers. The FDA will consider whether to issue new guidelines concerning Internet-specific regulations.
As anyone who watches television or reads magazines knows, the FDA requires drug companies to be as clear as possible about their claims for their products and to include an explanation of any potential risks related to their products in their ads.
Apparently, when it comes to search engines, social networks, and the blogosphere, those regulations have been more honored in the breach. Last April, the FDA sent warning letters to 14 companies, including Eli Lilly and Merck, about their online marketing practices, according to a Reuters article about this month’s hearing.
It’s an important issue, as more and more consumers turn to the Internet for information about products and services. Especially in the case of certain demographic groups, such as the elderly, accurate data about drugs and medication is vital. Also, more people are joining social networks and using digital forms of communication, such as text messaging or Twitter, which makes those avenues viable (and valuable) marketing venues.
Drug companies and marketers contend that such forms of communication don’t allow for long, detailed descriptors, information about risk, or warning labels.
The hearing has generated considerable discussion among interested parties in forums and blogs over the last week or so. Here are summaries of some of those discussion points:
- The Internet is an important source of healthcare information, and consumers need to be assured the information they are receiving is accurate and objective.
- Social networking is an increasingly important way for companies to interact with their customers, but drug manufacturers and marketers are unclear about FDA requirements or regulations in this regard.
- Who’s responsible for the information disseminated by marketers and advertisers? “We don’t think companies should be responsible for policing the entire Internet for information about their products,” said Johnson & Johnson executive Elizabeth Forminard at the FDA hearing, according to the Reuters story.
- How much (or, how much more) should the feds be involved in online activities? Do we really need or want federal regulators monitoring discussions going on in social networks and the blogosphere to ensure drug firms and marketing people are adhering to guidelines?
Several proposals were made at the hearings for how to go forward:
1) Pharmaceutical companies should be limited to promoting their products on their own Websites, where the content can be monitored by regulatory agencies.
2) The FDA needs to hire enforcers who are familiar with the social Web and can monitor discussions by pharmaceutical companies and their representatives about the efficacy and potential hazards of their products and those of their competitors.
3) The FDA should create a logo that pharma companies can use in search engine advertisements, on social networks, and on Twitter to alert consumers to where they can find FDA-mandated risk information about the products being advertised or discussed.
The FDA will accept written or electronic comments on the issue until February 28, 2010. For instructions on filing comments, go here.
— John Soat is a freelance journalist who specializes in business, technology, and security.