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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 Bloomberg BNA in an Aug. 21 email.
“Specifically, the FDA is proposing that drug manufacturers only mention severe, serious, or actionable risks in broadcast advertisements,” Kennerly said. “Drug injury lawsuits arise from those same severe and serious risks, and so this proposal would give drug manufacturers more time in their broadcasts to discuss those risks and thus a greater potential for consumer fraud or warranty claims if they improperly minimize those risks.”
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).
The FDA said there is a concern that current risk statements in DTC ads aren’t fulfilling their purpose. Many risk statements are very long and this could cause consumers to not understand the risks and to not take their medications due to the fear of side effects, the agency said.
Television ads often have long statements of risk information. Examples include television commercials for Eli Lilly & Co.'s erectile dysfunction drug Cialis, Pfizer Inc.'s smoking cessation aid Chantix, AbbVie Inc.'s arthritis drug Humira, and Sunovion Pharmaceuticals Inc.'s depression drug Latuda.
John Kamp, executive director of the Coalition for Healthcare Communication, told Bloomberg BNA in an Aug. 18 email 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.”
Kamp said “consumers now are often intimidated, put off and confused by the existing ads. Wouldn’t it be better in this case just to get on with it and enable better, consumer friendly ads?”
The Coalition for Healthcare Communication promotes the free exchange of scientific and medical information. It is composed of media, health-care, and other organizations.
Meanwhile, Michael Carome, director of Public Citizen’s Health Research Group, told Bloomberg BNA Aug. 18 that 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.
Carome said the goal of drug manufacturers that produce these advertisements “is to maximize their effectiveness and get people to seek prescriptions for these drugs from their health-care professionals and obviously the best way to do that is to emphasize the benefits and downplay the risks.”
Public Citizen “would oppose any effort to weaken the risk information presented and we favor approaches that strengthen the presentation of risk information in a way that improves understanding,” Carome said.
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The Federal Register notice is at https://www.gpo.gov/fdsys/pkg/FR-2017-08-21/pdf/2017-17563.pdf.
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
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