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Few Americans Understand FDA Approvals

December 30, 2021

According to survey results published in Pharmacoepidemiology & Drug Safety, only a quarter of Americans understand that FDA approval of a drug does not necessarily mean the drug will help patients. Furthermore, 17.5% of the 1,744 U.S. adults surveyed believed that an FDA-approved drug would actually cure the condition the drug is indicated to treat.

"Further investigation into public knowledge of FDA's [over-the-counter] drug and dietary supplement approval oversight yielded additional evidence of a lack of understanding related to the approval of such products," the study authors wrote. For example, most respondents (69.3%) thought that the FDA approves all overâ€theâ€counter drugs, while 24.9% believed that the FDA approves dietary supplements. Another quarter (24.5%) did not know.

Nearly a third (31%) of respondents also thought the FDA approves direct-to-consumer advertisements, as well as the risk or benefit statements within ads.

The authors noted that the misconceptions held by consumers may have a negative impact on public health. "For instance, we found that 42.9% of consumers were not able to accurately report that FDAâ€approved prescription drugs may cause harm," they added.

To help improve consumers' understanding, the researchers recommended that the FDA place banner ads on websites like WebMD.com containing brief messages about its drug approval process and ad regulation.

Sources: Endpoints News, December 17, 2019; Sullivan HW, Aikin KJ, David KT, et al. Consumer understanding of the scope of FDA’s prescription drug regulatory oversight: A nationally representative survey. Pharmacoepidemiol Drug Saf. 2019 December 12. [Epub ahead of print]

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