Literature DB >> 31833141

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

Helen W Sullivan1, Kathryn J Aikin1, Kathleen T David1, Jennifer Berktold2, Karen L Stein2, Victoria J Hoverman2.   

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.
© 2019 John Wiley & Sons, Ltd.

Entities:  

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

Mesh:

Substances:

Year:  2019        PMID: 31833141      PMCID: PMC7325631          DOI: 10.1002/pds.4914

Source DB:  PubMed          Journal:  Pharmacoepidemiol Drug Saf        ISSN: 1053-8569            Impact factor:   2.732


  14 in total

Review 1.  Utilizing social media data for pharmacovigilance: A review.

Authors:  Abeed Sarker; Rachel Ginn; Azadeh Nikfarjam; Karen O'Connor; Karen Smith; Swetha Jayaraman; Tejaswi Upadhaya; Graciela Gonzalez
Journal:  J Biomed Inform       Date:  2015-02-23       Impact factor: 6.317

Review 2.  Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues.

Authors:  Aaron S Kesselheim; John Connolly; James Rogers; Jerry Avorn
Journal:  Health Aff (Millwood)       Date:  2015-03       Impact factor: 6.301

3.  Direct-to-consumer prescription drug advertising and the public.

Authors:  R A Bell; R L Kravitz; M S Wilkes
Journal:  J Gen Intern Med       Date:  1999-11       Impact factor: 5.128

4.  Communicating uncertainties about prescription drugs to the public: a national randomized trial.

Authors:  Lisa M Schwartz; Steven Woloshin
Journal:  Arch Intern Med       Date:  2011-09-12

5.  Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.

Authors:  Dongyi Du; John Goldsmith; Kathryn J Aikin; William E Encinosa; Clark Nardinelli
Journal:  Health Aff (Millwood)       Date:  2012-05       Impact factor: 6.301

6.  Medical Marketing in the United States, 1997-2016.

Authors:  Lisa M Schwartz; Steven Woloshin
Journal:  JAMA       Date:  2019-01-01       Impact factor: 56.272

Review 7.  Under-reporting of adverse drug reactions : a systematic review.

Authors:  Lorna Hazell; Saad A W Shakir
Journal:  Drug Saf       Date:  2006       Impact factor: 5.228

8.  eHealth literacy and Web 2.0 health information seeking behaviors among baby boomers and older adults.

Authors:  Bethany Tennant; Michael Stellefson; Virginia Dodd; Beth Chaney; Don Chaney; Samantha Paige; Julia Alber
Journal:  J Med Internet Res       Date:  2015-03-17       Impact factor: 5.428

9.  Information to Improve Public Perceptions of the Food and Drug Administration (FDA's) Tobacco Regulatory Role.

Authors:  Amira Osman; Sarah D Kowitt; Paschal Sheeran; Kristen L Jarman; Leah M Ranney; Adam O Goldstein
Journal:  Int J Environ Res Public Health       Date:  2018-04-14       Impact factor: 3.390

Review 10.  Utility of social media and crowd-intelligence data for pharmacovigilance: a scoping review.

Authors:  Andrea C Tricco; Wasifa Zarin; Erin Lillie; Serena Jeblee; Rachel Warren; Paul A Khan; Reid Robson; Ba' Pham; Graeme Hirst; Sharon E Straus
Journal:  BMC Med Inform Decis Mak       Date:  2018-06-14       Impact factor: 2.796

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  2 in total

1.  Patient Perceptions of FDA Approval: Gaps in Education or Variation in Values?

Authors:  Paul J Ford; Robert J Fox; Mary Beth Mercer; Stacey S Cofield
Journal:  Neurol Clin Pract       Date:  2021-08

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

Authors:  Linda Härmark; Gerda Weits; Rietje Meijer; Federica Santoro; G Niklas Norén; Florence van Hunsel
Journal:  Drug Saf       Date:  2020-08       Impact factor: 5.606

  2 in total

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