Way back in September 2009, the Food and Drug Administration announced that it would begin using the social media site Twitter to share news and other information about drug safety and regulation. "Messages on Twitter provide consumers, healthcare professionals, the pharmaceutical industry, and others with timely information on new drug approvals, safety alerts, compliance actions, and consumer information," the announcement said.
It was curious that FDA mentioned the pharmaceutical industry. You see, drug and device companies have been feeling their way around the Internet and other new media, including Twitter, for several years without substantive guidance from the FDA. That's important because, under the Food, Drug and Cosmetic Act, there's a lot that's not permitted, but nobody's quite sure what is and what isn't. And if the industry guesses wrong, they could subject themselves to some pretty harsh civil and criminal penalties.
As Ed Silverman at Pharmalot explained in an op-ed posted yesterday, the agency has been promising for years that it would develop of a formal policy on the matter. As early as 1996, the FDA held a public meeting (see reference at the bottom of this document) to discuss issues related to the advertising and promotion of medical products on the Internet. Then, in November 2009, the agency held another public meeting, with the promise that it would soon thereafter develop guidance or other policies that addressed Internet promotion and social media. But, as Silverman notes:
"the guidelines didn't appear in the wake of the meeting. And they didn't appear by the end of 2010, despite an unofficial FDA deadline to push something out by New Year's Day. And then the agency missed another deadline, this one on March 31. By mid-year, FDA officials said they would stop setting deadlines."
Unfortunately, this is not a case of benign neglect. On April 2, 2009, FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) issued 14 Notices of Violation to drug manufacturers for their use of sponsored links on Web search engines that included the name of a drug and a brief statement about the disease it treats, while directing users to a separate website that contained complete benefit and risk information. Essentially, FDA decided to apply its its existing rules for conventional print ads, which stipulate that, if an ad contains the name of a drug or device and any affirmative statement about the product or the disease it treats, then all of the mandatory risk information must also appear in the ad. According to DDMAC, that means that a sponsored link or other Web ad may not read something like, "Learn How Spiriva May Help You Manage Your COPD" or "Online Resource for Women with Breast Cancer. www.Femara.com," unless the full risk disclosure also appears in the sponsored link. Having the risk disclosure "one click" away via the hyperlink is not enough.
Since sponsored links resulting from key word searches are generally limited to a around 100 individual characters, give or take, (See here, for an example), this policy effectively precludes the use of sponsored link drug ads. But the policy has far broader implications for other Internet and social media fora. Is it legal for a drug manufacturer to host a Facebook page or Web discussion group in which patients and doctors discuss medicines they're taking or prescribing if every single page view does not also include the complete risk disclosure? What about user generated tweets aggregated in a Twitter stream that's embedded on a company-sponsored website? No one really knows for sure how the FDA would treat those scenarios. And that's a problem.
Again, Silverman points out that, "With the advent of patient-centered 'participatory medicine' poised to become one of the century's great trends in health care, it's more vital than ever that consumers have access [to] well-vetted health information, available via where they live, online. The biopharma industry has recognized this, which is why so many companies have opted to take the risk to push ahead despite the lack of guidance."
As attorney Arnold Friede and I discussed in a short paper two years ago, "The FDA's approach to hyperlinked disclosures is particularly frustrating in light of the Federal Trade Commission's (FTC) more nuanced approach for advertising in other industries. The FTC does not categorically reject hyperlinked disclosures in determining whether an advertisement is misleading or not. Instead, when considering the adequacy of a required information disclosure, it examines the conspicuousness of the hyperlink, whether it signals the availability of risk information, and other contextual factors. Rather than ticking off arbitrary boxes, the FTC looks at an entire presentation and considers the 'net impression' that a 'reasonable man' would form when viewing the information aggregated on linked web pages."
Until April 2009, the pharmaceutical industry had assumed FDA would apply this so-called "one click" rule for its own purposes. After all, the whole point of a sponsored link is to drive traffic to the Web page where the reader can learn more information. But the agency seems to have rejected that common sense approach -- at least so far. Once the agency does settle on a formal policy for Internet and social media advertising, however, adopting the one click rule or some other policy that recognizes the unique limitations and added functionality of the Internet would not be unprecedented. After all, the FDA did something similar with television advertising.
In its "major statement" guidance for risk disclosures in television advertising, FDA acknowledges the inability of TV to carry contemporaneous and instantaneous disclosure of all risk information. Because TV ads are limited to just 30 or 60 seconds, the agency permits drug manufacturers to include just a brief description of the product's "most important risk information," while providing the full risk disclosure through alternative means, such as a toll-free telephone number, in print advertisements that appear concurrently in publications reaching the same audience likely to see the TV ad, or on the Internet.
What's that again?
It's an important point, so let me repeat it: FDA's television advertising policy allows viewers of a TV ad to be directed to a drug or device's full risk disclosure on a website not intrinsically connected to the commercial. However, under its current interpretation of the statute, drug and device manufacturers cannot direct readers of an Internet ad to another, hyperlinked, Web page to see the full risk disclosure. That's absurd! It is long past time for the FDA to set out a rational Internet and social media policy that recognizes the ease with which Internet users can navigate from one Web page to another, and to access information linked directly from the one they're currently reading.