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

Pharmacoepidemiol Drug Saf. 2020 Feb;29(2):134-140. doi: 10.1002/pds.4914. Epub 2019 Dec 12.


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.

Keywords: FDA; knowledge; pharmacoepidemiology; prescription drug; regulation; survey.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Community Participation / methods
  • Community Participation / psychology*
  • Drug Approval / legislation & jurisprudence*
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Prescription Drugs / standards*
  • Surveys and Questionnaires*
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence*


  • Prescription Drugs