NEJM: FDA's proposed risk-disclosure guidelines still aren't enough

Print 30 September 2015
Beth Snyder Bulik / FiercePharmaMarketing

As the FDA again reviews its guidance on disclosing prescription drug risk information, two New England Journal of Medicine articles are suspicious that new guidelines would change much for patients.

University of Arizona's Christopher Robinson

"The FDA is in the process of adjusting its DTCA [direct-to-consumer advertising] rules, aiming to provide greater assurance that patients receive due warning of the most significant risks--but its tweaks probably don't go far enough to really empower consumers to make smart decisions about the drugs they put into their bodies," said Christopher Robinson, a professor at the University of Arizona college of law.

In a further audio interview on NEJM.org, Robinson said the current laundry list of small print risks in print is "not unlike pages and pages of small print that come with our home mortgage or other consumer products."

And while pharma companies will likely be glad not to be forced to point up some of the scary but unlikely-to-occur side effects, Robinson said, they're also aware that if they don't disclose everything, it could come back to haunt them in court. If a rare side effect cropped up in a patient, a drugmaker could be sued for failing to disclose it.

"I really think you might see companies saying, 'Thanks, FDA, it's nice to have this additional discretion, but I'll tell you what, fine print is relatively cheap, we might as well just keep it all there.' In that sense, the FDA's reform here may not make a whole lot of difference," he said during the interview.

Robinson added in the audio interview, however, that there is research showing "ways that we could empower consumers, completely redesign disclosures to help people make sense of them. That's not what the FDA is doing here. So this very small step, I think the science suggests it probably won't hurt people, but there's no great evidence it's going to profoundly change consumer decision-making at all."

A second article in NEJM, written by a University of California, San Francisco, professor and a Johns Hopkins doctor, added a similar take on the kind of guidelines needed: "For all its capacity to encourage overdiagnosis and overmedication, DTCA's virtue is that it treats consumers as people who deserve to know something about the compounds they take into their bodies. After 30 years of DTCA, it's not clear that advertising is the best medium for communicating risk information, but marketers should at least be required to try to communicate risk information as effectively as they do their promotional messages."

Comments on the NEJM posts came mostly from doctors, who largely advocate discontinuing DTC advertising entirely in the U.S. Public comment on the FDA's second revision of the risk disclosure draft guidance--a change to the FDA's 2004 guidance--are due by Oct. 5. So far, 147 comments have been logged.

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