FDA May Limit 'Risk Info' in Direct-to-Consumer TV Drug Ads
FRIDAY, Aug. 18, 2017 -- The U.S. Food and Drug Administration may shorten the list of caveats for drugs you see advertised on television.
Prescription drug makers must now mention all benefits and risks in direct-to-consumer advertising, presenting viewers with a litany of potential harms, both major and minor. But a new approach being considered could trim those lists to feature only the most serious and potentially fatal side effects, the FDA said Friday.
The "FDA's own research on broadcast TV drug advertisements suggests that a more targeted method for delivering risk information may lead to better retention of those risks," FDA Commissioner Dr. Scott Gottlieb said in an agency news release.
To that end, "the agency is exploring the usefulness of limiting the risks in the major statement for most drug advertisements to those that are severe [life-threatening], serious or actionable, coupled with a disclosure to alert consumers that there are other product risks not included in the advertisement," Gottlieb said.
While this might spare TV viewers lengthy lists of relatively insignificant physical complaints, it might also deprive them of critical information.
To come to the best solution, the FDA is asking consumers, doctors and others to comment on which risk information is most helpful in TV and other broadcast ads.
Some doctors weighed in on the idea with approval.
Dr. Nachum Katlowitz, director of urology at Staten Island University Hospital in New York City, thinks it's time to reconsider the advertising requirements.
"In a one minute direct-to-consumer advertisement, they spend 55 seconds in a kind, clear, pleasing voice discussing all the wonderful things this product will do to help your life," said Katlowitz. "Then, in the last five seconds in a rapid, audible but difficult to understand monotone voice, they discuss the risks and end with, 'Ask your doctor.'"
He said it would be "much more honest, if not safer, if they start with someone clearly stating the following is intended as an infomercial and all questions regarding the proper use of this product are best discussed with and handled with your health care provider."
Dr. Minisha Sood, an endocrinologist at Lenox Hill Hospital in New York City, was even more enthusiastic about the FDA proposal.
"I applaud the FDA for seeking to improve how [direct-to-consumer] prescription drug advertising is conducted," Sood said. "My patients regularly bring up questions which arise from broadcast advertisements for pharmaceutical products and I encourage this, as it allows us to have a meaningful discussion regarding risks and benefits of the product.
"What I have realized in this process is that people do not retain the information presented as a lengthy laundry list of possible adverse reactions, which range from mild or moderate to severe," Sood added.
"Including a long list of risks in advertisements leads to confusion and doesn't add much in terms of patient understanding," Sood said. "As a well-informed physician, I can help my patients understand drug risks better than a 15- or 30-second commercial."
The U.S. Department of Health and Human Services has tips for using medication safely.
Comments on the FDA proposal can be made to the Federal Register on or after Aug. 21, 2017.
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Posted: August 2017