Consumer understanding of the scope of FDA's prescription drug regulatory oversight: A nationally representative survey

Abstract

Purpose: Misperceptions of how the US Food and Drug Administration (FDA) regulates prescription drugs may affect how consumers assess the safety and efficacy of prescription drugs. The study objective was to survey the public on their knowledge of FDA oversight regarding prescription drug approval and advertising. Methods:In 2017, we conducted a nationally representative mail-push-to-web survey with 1,744 US adults.Results: Although most respondents (86%) knew that FDA approves prescription drugs, we found misperceptions about what that approval means. In addition, few respondents understood FDA oversight of prescription drug advertising, with approximately half of respondents reporting that they did not know whether FDA approved these ads or components of the ads, and several mis-reporting that FDA approves these ads (31%) or components of the ads (22%-41%). Conclusions: Enhanced collaboration and communication with the public by key stakeholders in this space could increase public understanding of the roles and responsibilities of FDA.

Communicating Adverse Drug Reaction Insights Through Patient Organizations: Experiences from a Pilot Study in the Netherlands

“…The aim of pharmacovigilance is to reduce harm caused by adverse drug reactions, which requires that new knowledge reach the prescribers, dispensers and users of drugs. Effective communication with healthcare professionals and patients is essential [1][2][3]. Current channels for disseminating new information about adverse drug reactions include peer-reviewed scientific journals, the World Health Organization (WHO) Pharmaceuticals newsletter and the websites of drug regulatory authorities such as the European Medicines Agency and the US FDA.…”

Jordanian Population Knowledge, Attitude and Practices on the Uses of Antidiabetics for Weight Loss Purposes: A Cross Sectional Study

“…In contrast to a previous ndings, respondents generally demonstrated good knowledge about FDA approvals for the selected antidiabetic agents commonly used for weight loss. The highest was for (Mounjaro®) with a knowledge score of 85.91% [39]. However, both studies reported participants' opinion about regulatory agencies supervision as insu cient [39].…”

“…The highest was for (Mounjaro®) with a knowledge score of 85.91% [39]. However, both studies reported participants' opinion about regulatory agencies supervision as insu cient [39]. On the other hand, the participants of this study demonstrated fairly superior knowledge about the use of (Ozempic®) and (Saxenda®) in weight loss (47.27%, 44.55%, respectively) compared to another study conducted on Saudi population (33%, 31.8%, respectively) [40].…”

Patient Perceptions of FDA Approval

“…Despite this increased role, patient understanding and preferences regarding the FDA regulatory process are not well documented in the literature. 8 In our survey of over 3500 people living with MS, about twothirds understood many basic aspects of FDA approval, although only half understood a fundamental role of the FDA: balancing the risks and benefits when considering drug approval. Surprisingly, a significant minority (about 30%) of participants misidentified the meaning of FDA approval in at least one domain, especially in believing that drug risks would be "fully" understood and that there were no harmful side effects.…”

“…Despite this increased role, patient understanding and preferences regarding the FDA regulatory process are not well documented in the literature. 8…”