Evidence map›Paper›PMID 31833141›Full record

ArticlePharmacoepidemiology and drug safety2020

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

Helen W Sullivan, Kathryn J Aikin, Kathleen T David, Jennifer Berktold, Karen L Stein, Victoria J Hoverman

Abstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Helen W SullivanUS Food and Drug Administration, Silver Spring, MD, USA.ORCID 0000-0001-7621-7554
Kathryn J AikinUS Food and Drug Administration, Silver Spring, MD, USA.
Kathleen T DavidUS Food and Drug Administration, Silver Spring, MD, USA.
Jennifer BerktoldWestat, Rockville, MD, USA.
Karen L SteinWestat, Rockville, MD, USA.
Victoria J HovermanWestat, Rockville, MD, USA.

Funding

FDA HHSIntramural FDA HHS FD999999
6 · The paper itself

Abstract

purposeMisperceptions 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.

methodsIn 2017, we conducted a nationally representative mail-push-to-web survey with 1,744 US adults.

resultsAlthough 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%).

conclusionsEnhanced collaboration and communication with the public by key stakeholders in this space could increase public understanding of the roles and responsibilities of FDA.

Indexed as

Health Knowledge, Attitudes, PracticeSurveys and QuestionnairesCommunity ParticipationDrug ApprovalHumansPrescription DrugsUnited StatesUnited States Food and Drug AdministrationPrescription DrugsFDAknowledgepharmacoepidemiologyprescription drugregulationsurvey

Identifiers

PMID31833141
PMCPMC7325631

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.