Direct-to-consumer drug marketing is a scandal. Can the FDA fix it?

Two nations in the world allow drug companies to market prescription medicines directly to consumers: New Zealand and the United States. In the U.S. at least, the lack of effective regulation of what drugmakers say, and how, leaves consumers utterly at a loss when trying to understand the uses and risks of these intensely marketed products.

That’s the conclusion of Jeremy A. Greene of Johns Hopkins and Elizabeth S. Watkins of UC San Francisco, who write in the New England Journal of Medicine that discussions of side effects and contraindications are typically provided to consumers in package inserts whose “medical terminology, dense verbiage, and tiny fonts ... have made them inscrutable to the average consumer and virtually useless as information sources.”

The print and broadcast ads for the same products are even worse — colorful images of individuals happily liberated from the burdens of disease, accompanied by hastily babbled rosters of side effects or “one or two pages of dry text providing ... required disclosures,” often just repeating language intended for doctors prescribing the drugs, says University of Arizona law professor Christopher Robertson in a companion piece.

Now, the Food and Drug Administration is preparing to step in. The FDA has circulated a draft regulation that would require consumer information to be communicated in plain language and in (horrors!) a readable format.

The FDA is frowning on the usual impenetrable jargon of drug inserts and advertised warnings. The regulation aims to replace it with “a conversational tone or language designed to engage the reader.” Instead of the term “contraindications,” for example, the warnings should say, “do not use if you have... .” Instead of “somnolence,” use “drowsiness.” Not “syncope,” but “fainting.” No more small print, but fonts “selected or designed for readability;” double-spacing between paragraphs and more white space to draw the reader in.

This is all important because studies have shown that more than 40% of drug consumers don’t usually look at the warning summaries in prescription drug ads, and of those who tried, 55% find them hard to read.

Any television viewer knows that the list of side effects can be over in a flash or easily overlooked, even if they’re horrific. In a commercial for the prescription sleeping pill Lunesta, for example, such possible side effects as aggressiveness, agitation, hallucinations, and “deepening of depression, including risk of suicide” are reeled off in the same soothing, soporific voiceover that mentions the drug’s virtuous ability to deliver a good night’s sleep.

This isn’t the FDA’s first effort to regulate consumer information, according to Greene and Watkins’ report. The last effort started with the birth control pill, which was shown in the 1960s to have potentially fatal safety risks years after it became widely prescribed.

The FDA ordered disclosure of the pill’s safety risks in clear language, but doctors and drugmakers fought back; the proposed disclosures became progressively more “anemic,” the authors observe, until the final version removed all references to any adverse symptoms at all. In 1979, the FDA proposed plain-language disclosures for all prescription drugs, but that effort died under pressure from the anti-regulation Reagan Administration.

What was left was a “voluntary approach,” which remained in place even after 1985, when the FDA started to allow drug companies to advertise in newspapers and magazines.

Will the FDA rules work, once they’re implemented? Robertson is skeptical. He calls the rules “modest” and points out that by encouraging drugmakers to limit their disclosures to the most serious or common side effects in the interest of reducing consumer confusion, the draft rules may give manufacturers too much discretion about what to leave out.

Robertson says the FDA could have proposed greater restrictions, “perhaps cracking down on industry’s use of noncognitive persuasion (think bathtubs in a field of flowers to suggest the romance made possible by an erectile-dysfunction drug), which may undermine rational decision making by patients.” He acknowledges, however, that such rules might run afoul of the Supreme Court’s favoring of free-speech rights for commercial entities.

Greene and Watkins see some direct-to-consumer marketing as a positive in treating consumers as stakeholders entitled to more information about their own healthcare. But they caution that 30 years of such marketing leaves room for doubt that “advertising is the best medium for communicating risk information.” The drug companies, they say, “should at least be required to try to communicate risk information as effectively as they do their promotional messages.”

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