FDA Scrutiny on Ads That Tout Illegal Drug Imports

The Food and Drug Administration is threatening legal action against companies that help Americans import prescription drugs from Canada—an illegal practice—and the liability could extend to U.S. agencies that prepare the ads and the media outlets that carry them.

The FDA had been reluctant to prosecute senior citizens seeking access to cheaper medications. But in a letter sent last month to some health-insurance companies, the FDA warned that parties “who cause a prohibited act” can be found “civilly and criminally liable” under the federal Food, Drug and Cosmetic Act. “Those who aid and abet a criminal violation of the act, or conspire to violate the act, can also be found criminally liable,” said the letter, dated Feb 12.

The liability issue was raised by one attendee at the American Advertising Federation’s Government Affairs Conference last week at The Washington Post. After his speech, FDA Commissioner Mark McClellan was asked whether the agency intends to hold agencies and media outlets accountable for ads promoting Canadian drug outlets. “Read the [Feb. 12] letter very carefully,” he responded.

The FDA later confirmed that advertising agencies and media outlets are vulnerable. “We could take action, because it is pretty clear that directly facilitating the … importation of drugs is a violation of the law,” a senior FDA official said.

The FDA says a growing number of direct-to-consumer ads for prescription drugs from Canadian companies are appearing in U.S. media. For example, a full-page ad in the Feb. 14 issue of The Washington Post touted a Winnipeg-based pharmacy, telling consumers they could “save up to 86 percent” on prescription drugs. The ad also claimed, “Look how easy Congress has made it for you to save,” referring customers to an 800 number and a Web site.

Brenda Boykin, associate counsel at The Post, said, “We are looking into this issue.” It is not clear whether the client, Canada Discount RX, used a U.S. agency to prepare the ad. The company did not return calls.

“There is no First Amendment protection for running an ad for a product that is not legally sold,” said John Kamp, an advertising attorney with the Washington law firm Wiley Rein & Fielding. “In some cases, the media itself can be seen to be as responsible as the advertiser and the ad agency.” The Federal Trade Commission’s policy is to hold liable “anyone who knew or should have known” about an ad for an illegal product, he said.

The warning comes at a time when Congress is debating whether direct-to-consumer ads for prescription drugs drive up the cost of healthcare. Last year, drug makers spent $2.5 billion on prescription-drug ads, according to CMR. In addition, the FTC has asked media companies to pay closer attention to the health claims made in dietary-supplement and weight-loss ads. The agency has stepped up its enforcement of fraudulent health claims, but says it cannot keep up with the numerous ads that make such claims.

Also speaking at the Government Affairs Conference, FTC Commissioner Timothy Muris said he hopes the media will cooperate with cases of fraudulent health claims, particularly in the weight-loss area. “Reputable publications have carried these ads, and there is a growing problem,” he noted. “There is no constitutional right to run false advertising.”