F.D.A. Rules on Drug Ads Sow Confusion as Applied to Web

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When the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, the warning was strong. The companies’ search advertisements — the short text ads that run beside Google results — had to start including risk information about each drug or else be rewritten or removed.

Just how the companies were supposed to comply was not so clear. In the 95 characters that Google allowed for search ads, there was no way to include all the required information, the companies argued.

Now, as the companies change their search ads to comply with the letters, industry executives say the solution is worse than the problem: their ads are even more confusing and misleading now, they say. And they worry that regulators will enforce standards that were created for magazines and television, rather than making new rules that acknowledge how Internet ads have evolved.

The letters were sent to almost all of the major pharmaceutical companies, including GlaxoSmithKline, Pfizer, Merck and Eli Lilly. The letters said ads for widely prescribed drugs, including Celebrex, Propecia and Yaz, did not include the paragraphs of precautions the agency required.

Though the texts of the ads varied, the agency’s objections to each ad were similar. One such ad was for Merck’s allergy drug Singulair. The ad read, “Allergy Medication Relief of Allergy Symptoms: Learn About a Treatment Option. http://www.SINGULAIR.com.”

The ad omitted “the most serious and frequently occurring risks associated with the drugs promoted in the links above,” the agency wrote in its letter to Merck, and the links “misleadingly suggest” that the drug was “safer than has been demonstrated.”

Until these letters were sent, pharmaceutical and media companies had assumed that there was a one-click rule, said Arnie Friede, counsel at the corporate law firm McDermott, Will & Emery: as long as pharmaceutical companies provided risk information within one click of their search ads — on the page that the ad linked to — they assumed they were in compliance. These letters made clear that was not the case.

“If you don’t provide the required name, if you don’t provide risk information, if you overstate the benefit of the use of the drug, that is a false and misleading ad,” Rita Chappelle, an agency spokeswoman, said in an interview. “It is vital and critical to consumers that they get that information.”

Ms. Chappelle said that information was required despite the length limitation of Internet search ads.

“Our laws for how products that are approved by the agency can be marketed to consumers are the same regardless of the medium, whether they are print ads, radio ads, television ads or Internet ads,” she said. Consumer advocates applauded the agency’s move.

“Why should a drug company be able to advertise one of its products in the best possible light in 25 or 40 or 150 characters when you can’t disclose all the side effects in that space?” said Jamie Court, the president of Consumer Watchdog, a public interest group in Santa Monica, Calif. The Obama F.D.A., he said, was realizing “that digital marketing needs to encompass tougher standards than are currently being put into use by the drug companies.”

But the drug industry argues that the agency is ignoring the realities of Internet marketing, and is not issuing clear rules about compliance.

The agency “has not issued specific regulations or guidance for Internet promotion,” Elizabeth Baxter, a spokeswoman for Sanofi-Aventis, said in a statement. Although the company is adjusting its ads, “Sanofi-Aventis believes that the links were consistent” with agency requirements “for the provision of risk information,” Ms. Baxter said.

The companies say that there is no way to include all required risk information in a search ad and that consequently the ads they are creating are confusing.

“Even if you were to take all other text off and say ‘This is a very dangerous drug,’ that wouldn’t do it,” Mr. Friede said.

Companies began changing almost all of their drug ads as soon as they got the letters, immediately removing the ads that had been cited, said Mary Ann Belliveau, health industry director at Google.

But the sense in the industry was “that the F.D.A. sent letters about ‘you shouldn’t do this, you shouldn’t do that,’ as opposed to issuing clear digital guidelines that the companies should follow,” she said.

Companies considered the agency’s risk-disclosure requirements, which come into play when a brand name is included either in an ad or in a link in the ad. To avoid the risk-disclosure rule, companies are now using generic-sounding Web addresses that redirect users to the brand’s site.

Propecia, which was cited by the F.D.A., now runs ads with a link not to Propecia.com, but to a site called hair-loss-medication.com that redirects to Propecia.com. Another solution companies are using is to include the brand name and generic name, but to remove any mention of what the product treats, which results in ads like, “Flomax® (tamsulosin HCl) http://www.4FLOMAX.com Capsules, 0.4 mg – Official Site for Important Product Information.”

All of these solutions have a few problems, advertisers say. One is that someone clicking on ManageOsteoporosis.com or a similar generic link may assume they are getting neutral information when they are actually being redirected to a sales site.

Google, in fact, will not let any advertiser except for pharmaceutical companies use this kind of redirecting link, Ms. Belliveau said. Another is that someone searching for a specific brand will now rarely see the official site in sponsored search results — instead, a variety of Canadian pharmacies and unregulated herbal offerings take up the top spots.

Industry executives and consumer advocates say this may be a sign of increased vigilance by the agency. The letters were made public at the end of the acting commissioner Joshua M. Sharfstein’s first week on the job, and President Obama has vowed to make strong F.D.A. regulation a priority. But pharmaceutical industry representatives, including Mr. Friede, are asking the agency to consider how Internet marketing is different as it enforces its rules.

“While a technical violation, this is the kind of thing, especially in the new media environment we’re in, that deserves a good conversation and recognition of the media reality that we’re operating in,” said John Kamp, the executive director of the Coalition for Healthcare Communication, a pharmaceutical industry group.

“No company wants a warning letter from the F.D.A., so they’re going to comply,” he said, “but it will mean there won’t be as effective search advertising; it’ll be harder to do in an effective way. But F.D.A.-regulated companies can only stay in business if they’re on the right side of the F.D.A.”

Consumer Watchdog
Consumer Watchdoghttps://consumerwatchdog.org
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