Communicating drug risks in pharma marketing: A new FDA challenge

pill bottle label

Photo: Joel Rorabaugh via

Many American consumers may not realize this, but only New Zealand and the United States are the only countries with strong pharmaceutical regulations in which direct-to-consumer advertising from pharma companies is allowed.

All those TV commercials and double-spread ads for prescription drugs – whether it’s for erectile dysfunction drugs or mental disorders or high blood pressure or some chronic condition – are missing from the media in most of the world.

The way such ads look and sound (including the usual mind-numbing text block tucked into a print ad detailing risks and potential side effects, or a hastily spoken voice-over toward the end of a commercial), may soon change. The U.S. Food and Drug Administration is revising regulations governing how companies communicate risk to consumers.

A recent commentary in the New England Journal of Medicine discusses the impending changes and how we got to this point, including public outrage over poor communication about birth control pill risks in the 1960s and deregulation in the 1980s that led to an explosion of pharmaceutical marketing. The commentary provides a concise, but thorough history of risk communication to consumers regarding potential harms and risks of prescription drugs.

It’s a history that every journalist who writes about medical treatments should be familiar with, because it reveals how inadequate sincere transparency about drug side effects has been over the past half century. The FDA finally appears to be acknowledging that in the Information Age there are no more excuses for poorly conveying the risks of using various drugs.

We’ve previously highlighted the need for journalists to do a better job than public officials at communicating risk about diseases and public health emergencies. The same is true for health journalists conveying the risks of drugs they write about, such as researching and explaining a drug’s number needed to treat or number needed to harm.

Printing 1,000 tiny words in a magazine fold-out ad about every possible adverse event that occurred with a drug during clinical trials is not a truly good faith way for pharmaceutical companies to convey the risks of a particular medication to consumers, given what research has uncovered about risk communication. Such blocks of text are intimidating, possibly frightening, and they rarely help a consumer understand what they really want to know: what is most likely to happen, what’s the worst that can happen, and how often does the worst actually happen?

What is the best way to communicate that information? What is a not-too-much, not-too-little, Goldilocks-sized dose of a drug’s risks upon which regulators, policymakers, medical professionals and industry will agree? That has always been a question. As the FDA learned during the 1960s birth control pill brouhaha, the NEJM commentary notes, “there was no clear consensus on how best to provide risk information to patients.”

Two differences today include technology tools that offer new methods, formats and interfaces of sharing risk information, and a significantly more robust evidence base about health literacy and risk communication. There also is the new media environment that provides (and amplifies) consumer voices.

“The U.S. medical consumer’s voice has grown stronger since the 1970s, and the FDA increasingly relies on social scientific research in its decisions,” the commentary’s authors point out. “Nonetheless, the success or failure of the current proposal depends on the agency’s ability to capture the interests of all stakeholders.”

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