FDA to Hold Hearing on Social Media, Web 2.0; Long Overdue Guidance Could Be On Its Way

The FDA is to hold a public hearing on how drug companies use the web and other social media to promote pharmaceuticals. The news will be greeted warmly by the industry which for years has been complaining that brand managers do not know how far the FDA will allow them to go in media such as Google ads, Twitter, Facebook, and even on their own web sites. There are three hotbutton issues on the FDA's agenda:
  1. How should potential adverse events reported on social media be handled by companies?
  2. What level of disclosure should there be regarding third party communications that may have been influenced by the marketer?
  3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
The adverse-event issue has been the one that has really tied Big Pharma's hands. Companies know that if they allow users to contribute content -- even comments -- on a drug web site they may attract adverse event reports. Those reports must be filed with the FDA, and plaintiffs' lawyers trawl the FDA databases looking for potential mass tort cases against the companies. Thus drug companies have historically refused to allow users to interact with their web sites. (Johnson & Johnson is a notable exception.)

The issue around disclosure of ties to third parties will be mediated by a separate inquiry, from the FTC, into the same issue regarding celebrity and blogger endorsements of products. The feeling among some at the agency is that it is no longer acceptable for stars or bloggers to rave about products if a company has paid the endorser or given him/her any kind of freebie, and the relationship is not disclosed.

It is the third issue, on how companies should be able to post corrective information on third-party web sites, that will be most welcomed by the industry. For years, compliance offices have prevented brand teams from responding to incorrect information on the internet out of fear that a published disclosure that they cannot control may somehow be used against them in litigation. Rules that would allow drug companies to "join the conversation" (as the industry lingo puts it) will be greeted with cries of joy in Pharmaland.

And finally: The hearing holds the tempting promise that the FDA might at last allow drug companies to join the 21st Century. Here's my humble suggestion: It will be impossible to continue to require companies to disclose all safety risks every time information about a drug is posted. A Google ad consists of a dozen words. A Twitter tweet is only 140 characters. The FDA may have to give up that requirement in some media, as long as the risk information is a mere click away.

However, in doing so the FDA should require a counterweight in the opposite direction. On branded and unbranded sites controlled by pharma companies, there should be a stricter duty to disclose risks and safety information in a more complete and obvious manner. Linking to a PDF of the PI on a page labeled "information for physicians" should no longer be enough. The information needs to be displayed in both plain English and in the original as approved on the PI, so that patients who want to research more can go as in-depth as they like.

While most companies already do this, some do not. Galderma was recently caught using a fake PI. And Allergan failed to disclose that one of the risks of the eyelash lengthener Latisse -- a drug it just launched -- is bacterial keratitis infection.

Perhaps if the FDA promises to at last get serious about the web, drug companies can do the same.