Drugmakers could face litigation risks if the FDA moves forward with a proposal to shorten prescription drug ads’ risk information.
The Food and Drug Administration is investigating whether it should limit risk statements in direct-to-consumer (DTC) drug ads to only serious, life-threatening risks, along with a disclosure that the drug has other risks not included in the ad.
“The FDA’s changes would give drug companies a little more leeway in their advertisements, and with more leeway comes more potential for liability,” Max Kennerly, an attorney with Kennerly Loutey in Philadelphia, who represents plaintiffs in drug and medical device cases, told me.
The agency’s action isn’t a rule or even a proposed rule yet. The agency said in an Aug. 21 Federal Register notice (82 Fed. Reg. 39,598) it is opening a public docket to get comments on its proposal. Comments are due Nov. 20 (Docket No. FDA–2017–N–2936).
Michael Carome, director of Public Citizen’s Health Research Group, told me while it’s unclear where the agency is headed, “we certainly don’t want to see any weakening of the disclosure of risk information in direct-to-consumer advertising. We have long opposed such advertising.” Public Citizen is a consumer group.
“Ultimately, it’s critically important that there be a balance between information presented about risks and information presented about benefits,” Carome said.
However, John Kamp, executive director of the Coalition for Healthcare Communication, told me he wants the FDA to act immediately to limit risk information. He prefers bolder action to creating a docket and delaying a final action.
“In this case it’s obvious that the existing disclosures are counterproductive,” Kamp said. “Every professional advertiser knows that short, simple messages are better understood and retained than complicated ones.” The Coalition for Healthcare Communication promotes the free exchange of scientific and medical information. It is composed of media, health-care, and other organizations.
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