Independent Study: Mum’s the word: FDA regulation and new media and internet marketing

Live-streaming video. Podcasts. Online communities. YouTube channels. Widgets. Wikis. Microblogging. Snaps.

They are all part of our everyday vernacular. However, pharmaceutical companies are operating in a gray area when it comes to these new media tools used and accessed freely each day by millions of people.

The FDA strictly regulates product claims advertising, advertising which specifically names a drug, and requires that messaging about a drug describe the indication or condition to be treated, as well as any side effects. And rules and regulations are well understood. However, in the review Chasing Technology: A Call for FDA Regulation of Pharmaceutical Internet Marketing, Richardson argues that the current set, as of 2012 when the article was written, of regulations prove useless and inadequate when it comes to internet marketing and new media communications. She calls for the FDA to set froth rules and regulations and to stop piecemealing regulation and enforcement for internet marketing, which is what the FDA has done since 1996 when it held a public meeting where the need for regulation was expressed. In 2009, the FDA held another public hearing to discuss internet communications, and again in 2011 lightly touched the subject when discussing unsolicited request for off-label drug information. Still, no final regulation exists specifically for internet communications and new media. Although some guidance was released in 2014, it exists in draft form.

Pharmaceutical companies “can only guess what types of marketing the FDA will consider the most responsible way to take advantage of the new technology while still complying with the current regulatory scheme” (p. 252). Those who have ventured into the unknown have faced harsh penalties and rulings on a case-by-case basis as they explore these new media tools. Does a tweet with a hyperlink to page listing side effects adhere to the rules? What is a page? In traditional advertising, the FDA calls for companies to list indication and side effects on the same page as the product ad. But, what’s a page on the internet? Without a clear set of guidelines, it’s up to interpretation. And interpretation is not a comfortable place for pharmaceutical communications teams to be in.

screen-shot-2016-10-09-at-11-14-24-amMany companies had employed a self-imposed “one-click rule” where an advertisement would contain a link to the indications and side effects— just one quick step for consumers to take to find this information. But, in 2011, Novartis received a notice-of-violation letter from the FDA for their Facebook campaign that had employed this one-click rule. Effectively, the self-imposed “rule” was dead.


Richardson argues that “rather than waiting until internet marketing causes some sort of public health crisis, as the FDA has done in the past before promulgating new rules, the FDA should put a strong regulatory scheme in place that incorporates the public agenda and addresses all forms of internet marketing” (p. 295).

The FDA issued draft guidance in 2014. But, still in draft and potentially not addressing all needs, does it miss the mark?

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