FDA survey finds Americans don’t really understand drug approvals
Only 25% of Americans understand that a new drug approved by the FDA does not necessarily mean the drug will help most people who use it, according to the results of a survey conducted in 2017 and published last week in Pharmacoepidemiology & Drug Safety.
However, FDA’s survey of a nationally representative group of 1,744 US adults did find that more than half understood that the regulator approves prescription drugs when the drug offers benefits that outweigh the risks, although 17.5% thought that an FDA-approved drug will cure the condition for which it’s prescribed.
“Further investigation into public knowledge of FDA’s OTC [over-the-counter] drug and dietary supplement approval oversight yielded additional evidence of a lack of understanding related to the approval of such products. We found that 69.3% of respondents thought that FDA approves all over‐the‐ counter drugs. One quarter of respondents (24.9%) believed FDA approves dietary supplements and another quarter (24.5%) did not know,” the survey’s authors found.
In addition to the findings on the approvals, the researchers also sought to understand how the public views FDA’s role in regulating direct-to-consumer (DTC) prescription drug advertising.
FDA researchers found less of an understanding with DTC ads, noting that 31% incorrectly thought that FDA approves DTC advertising, and less than half incorrectly thought that risk or benefit statements in ads are FDA‐approved.
Although the researchers said the survey aligns with previous surveys, they also said it suggests “that some of 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 FDA‐approved prescription drugs may cause harm. This is concerning because some adverse events require discontinuation or dose modification. Moreover, adverse event reporting is critical to pharmacovigilance and under‐reporting of adverse events is a consistent problem worldwide.”
They also explained how there is an opportunity to enhance consumers’ understanding of drug approvals, FDA’s role and oversight of prescription drug advertisements.
As far as potential ways to improve the public’s understanding on drug approvals, one of the suggestions is to place banner ads on general health reference websites, like Drugs.com, WebMD.com and mayoclinic.org, with short messages offering key facts about the approval process and regulation of advertisements.
First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products.