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FDA: Consumer Drug Ads ‘Unreliable’ & ‘Potentially Misleading’

FDA: Consumer Drug Ads ‘Unreliable’ & ‘Potentially Misleading’
FDA: Consumer Drug Ads ‘Unreliable’ & ‘Potentially Misleading’

Many direct-to-consumer (DTC) drug ads don’t meet FDA regulations, according to a new study published in the Journal of General Internal Medicine.

And even though off-label promotions, which are ads that promote medications for uses other than what the FDA has approved, are not allowed, the study found they are commonly broadcast.

Researchers examined whether DTC ads followed FDA guidelines, which prevent companies from advertising misleading claims and require a fair assessment of the risks and benefits of a drug. The team collected and analyzed 97 unique DTC ads — consisting of 60 drugs and 67 drug–indication combinations — that aired from January 2015 to July 2016.

The results found that very few DTC ads fully complied with the FDA guidelines. All of the ads failed to present appropriate information when describing the risks associated with the medications, while 25 ads presented good-quality information on the drug’s effectiveness.

Thirteen ads that promoted diabetes medications suggested off-label uses for weight loss and blood pressure reduction. Overall, there was a lack of quality information within the televised ads and the promotion of off-label use was far too common in medications for diabetes.

“Our findings suggest that the information provided is unreliable and potentially misleading,” the authors wrote.

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