Industry Sets Its Social-Media Regulatory Position With DDMAC

Saying that FDA should not impose “horse-and-buggies” rules meant for print communications onto the automobile-equivalent world of online social media, PhRMA filed its comments with the FDA Div. of Drug Marketing and Communications (DDMAC) at the end of February. That time was the deadline for providing comments to FDA coming from a Federal Register notice last September, and that notice was also the announcement of a two-day hearing held in Washington in mid-November (Pharmaceutical Commerce, Nov/Dec, p. 6).

Social-media engagement in networks like Facebook or LinkedIn, in blogs and other interactive tools, and via new channels like Twitter has exploded, and various studies show that half or more of the American public are getting health information in some form from the Web. Pharma industry engagement in these media was perking along until last spring, when DDMAC sent out warning letters that online actions such as a paid-search banner violating FDA’s fair balance rules because patient warnings were not included right there where the search result appeared. The action put a chill through the pharma companies, which reasonably asserted that everyone else could freely talk about its products on the Web, so why couldn’t they? The irony is compounded because the pharma industry is essentially the only party to the discussion in a position to post FDA-approved language about products.

In its filing, PhRMA proposes three operational practices that it would like DDMAC to adopt:

1. A “universal symbol” indicating the presence of FDA-regulated risk information (see Figure). This would enable the public to distinguish official documentation from the commentary or data of others, and would “shine a brighter spotlight on official websites of FDA-approved medical products containing reliable and comprehensive information,” says PhRMA.

2. Introductory warning information, and not a full-blown fair balance statement, which would be accessible one click away. This is a version of the “one-click” policy that DDMAC originally objected to; the difference here is that there would be a clear pointer to where the fair balance information is accessible. PhRMA also suggests that FDA could require a standard link text, such as: “All drugs have risks. Click here for more information from the manufacturer.”

3. “Responsible” microblogging of newsworthy regulatory events. PhRMA wants to be able to communicate “scientific information that is neither advertising nor promotion” without prior FDA review; it notes that FDA itself is now an active user of Twitter.

DDMAC has indicated that it expects to produce proposed regulations before the end of the year. The current regulatory limbo has not stopped pharma companies, from being active on the Web, albeit in a constrained manner. Some pharma companies are already using the one-click banner more or less as PhRMA has suggested and are waiting to see how DDMAC will respond to it.

DoseofDigital.com, an agency-sponsored website, has collected dozens of sites, Facebook accounts, Twitter accounts and blogs sponsored by pharma companies. Ad agencies and healthcare communication services are nothing if not social creatures; a site called FDASM.com has been opened where these companies are discussing social-media policies and technology. PC