FDA's lack of digital rules creates confusion

Recent warnings against online pharma ads have reignited the debate about FDA regulations

On April 3, the Food and Drug Administration (FDA) sent letters to 14 drugmakers warning them to stop using what it called “misleading” and “misbranded” Internet ads for 48 drug products.

The agency said the online ads from a variety of manufacturers failed to provide the proper risk information.

However, for years, companies viewed the ads, which are called reminder ads and show up as sponsored search results, as acceptable because fair balance and risk information was included “one click” away on drug-branded sites.

The confusion is widespread gauging by the diversity of those that received warning letters: Pfizer, Johnson & Johnson, Eli Lilly, Merck, Bayer, Biogen, Boehringer Ingelheim, Cephalon, Forest Laboratories, Genentech, GlaxoSmithKline, Novartis, Roche, and Sanofi-Aventis.

“I don't think that 14 companies were just blatantly violating the rules,” says Kevin King, MD of Edelman Digital. “Those 14 companies were pretty unclear of what the rules actually were.”

The FDA, however, maintains that online marketing is subject to the same rules already established to monitor TV, radio, and print.

“The laws are the same, regardless of the medium,” says Rita Chappelle, press officer for the FDA's office of public affairs, who notes that it is the first time the agency has warned drugmakers about the use of search engines for marketing purposes. “It cannot be false and misleading.”

But as more pharmaceutical companies become involved in social media, the FDA will have a responsibility to better define the regulatory parameters of the digital space, including paid keyword advertising, wikis, Twitter, and YouTube. Lacking a policy that detailed how to adopt these rules for the Web, companies followed the one click ad hoc system, which they've now been punished for and had taken off the table.

“To ignore it like it's not happening or to assume that the old rules can apply 100% of the time isn't apt,” says Mark Senak, a SVP at Fleishman-Hillard, who also blogs for Eye on FDA. “By not enunciating clear policy to address some of the nuances raised by some of the technical aspects of the Internet, [the FDA is] leaving the regulatory parameters to be guessed at and then enunciated by warning letters, rather than policy, which is a really poor way to go about setting policy.”

Paid keywords such as these are usually a part of a company's reputational management strategy, King says, and when a product is in crisis, offshore pharmacies, class action lawyers, and alternative therapies are likely to buy ads for the sponsored search results, diluting the information about a particular drug or therapy.

“The whole social media space is not fitting into a lot of the FDA rulings to date,” he says. “And it's been very challenging to interpret, apply precedence, [and] try to find other examples of companies doing things in a space that's constantly changing and lacks consistency between each individual network.”

The companies have 15 days to respond to the letters and take down the advertising, Chappelle says. In the meantime, the pharmaceutical companies will have to learn to work under the new precedent in lieu of the government agency issuing a specific rule on the Web.

Ray Kerins, VP of worldwide communications at Pfizer, says what is important is that the company continues to reassess that its communications remains within FDA guidelines. He adds that “the idea that they're looking at this is obviously significant and important to the corporations who abide by the guidelines.”

But until clear rules are established, confusion could crop up in other areas as companies vie to ramp up efforts in the digital space.

“You had an entire industry of people thinking that they were doing something that was consistent with the regulations,” King says. “If there's been any example to the confusion in the industry, this is a key example.”

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