The Role of the Federal Trade Commission in Regulating Drug Advertising: 1975 Perspective

Thomas J. Donegan

doi:10.1177/002204267600600118

The Role of the Federal Trade Commission in Regulating Drug Advertising: 1975 Perspective

Journal of Drug Issues ◽

10.1177/002204267600600118 ◽

1976 ◽

Vol 6 (1) ◽

pp. 99-104

Author(s):

Thomas J. Donegan

Keyword(s):

Federal Trade Commission ◽

Over The Counter ◽

Drug Advertising ◽

Drug Products

This article outlines the responsibilities of the Federal Trade Commission in protecting the consumer against false, misleading or deceptive over-the-counter drug advertising. In addition to its current efforts, the Commission hopes to review the FDA Review monographs to determine how those findings should be extended to the advertising of OTC drug products.

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The Role of the Federal Trade Commission in Regulating Over-the-Counter Drug Advertising

Journal of Drug Issues ◽

10.1177/002204267400400309 ◽

1974 ◽

Vol 4 (3) ◽

pp. 232-237

Author(s):

Thomas J. Donegan

Keyword(s):

Drug Abuse ◽

Empirical Research ◽

Federal Trade Commission ◽

Primary Concern ◽

Over The Counter ◽

Drug Advertising

Mr. Donegan's presentation touches upon some of the legislative and administrative problems facing the FTC in reviewing unfair practices in drug advertising. The FTC's primary concern is with the truthfulness of advertising practices and is now requiring substantiation of drug claims. Mr. Donegan sees a move in the direction of reviewing the possible relations between drug advertising and drug abuse. He actively encourages empirical research to substantiate this charge.

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The Role of the Federal Trade Commission in Regulating Non-Prescription Drug Advertising and Promotion

Journal of Drug Issues ◽

10.1177/002204269202200207 ◽

1992 ◽

Vol 22 (2) ◽

pp. 265-276 ◽

Cited By ~ 2

Author(s):

Marianne R. Watts ◽

Judith D. Wilkenfeld

Keyword(s):

Prescription Drug ◽

Drug Administration ◽

Federal Trade Commission ◽

Food And Drug Administration ◽

Over The Counter ◽

Drug Advertising ◽

Prescription Drug Advertising ◽

Advertising And Promotion

The article focuses on the manner in which the Federal Trade Commission regulates advertising in general and over-the-counter drug advertising in particular. It also highlights the cooperation that exists between the Commission and the Food and Drug Administration in both food and drug matters.

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Research on the Effects of Over-the-Counter Drug Advertising

Journal of Drug Issues ◽

10.1177/002204267400400307 ◽

1974 ◽

Vol 4 (3) ◽

pp. 223-226 ◽

Cited By ~ 3

Author(s):

Donald L. Kanter

Keyword(s):

Drug Misuse ◽

Pharmaceutical Advertising ◽

Drug Usage ◽

Over The Counter ◽

Drug Advertising ◽

The Social ◽

The Media ◽

Commercial Advertising ◽

The Impact

Dr. Kanter presents a summary of his research assessing the role of OTC advertising in Influencing drug usage. His work represents the only systematic study of the impact of commercial advertising on drug usage. He stresses that advertising in itself does not directly lead to drug misuse but should be considered as part of a host of factors in the social environment and in the media environment that have significant influence in determining people's behavior. He also urged that the existing pharmaceutical advertising codes, which are often violated, be reviewed and strengthened.

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The Role of the Food and Drug Administration in Regulating Drug Advertising

Journal of Drug Issues ◽

10.1177/002204267400400320 ◽

1974 ◽

Vol 4 (3) ◽

pp. 291-296 ◽

Cited By ~ 1

Author(s):

Henry Simmons

Keyword(s):

Drug Administration ◽

Prescription Drugs ◽

Over The Counter ◽

Drug Advertising ◽

Monitoring Drug ◽

Psychotropic Agents ◽

Decisive Action ◽

Drug Detail ◽

Society Research

Dr. Simmons presents some of the problems and reactions within the FDA's Division of Drug Advertising regarding drug promotional activities. These include consumer labelling of over-the-counter and prescription drugs, the issue of monitoring the activities of drug detail men and reviewing advertising claims and campaigns. One of the problems in monitoring drug advertising is due to the division of responsibility between the FDA and FTC. Outlining their distinct functions, it is pointed out that more and more these two agencies are collaborating to bring some measure of unity and decisive action in this area. While drug advertising appears to have a profound effect upon the increased use of drugs, particularly psychotropic agents within our society, research is needed to substantiate this hypothesis.

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Future Pharmacists’ Opinions on the Facilitation of Self-Care with Over-the-Counter Products and Whether This Should Remain a Core Role

Pharmacy ◽

10.3390/pharmacy9030132 ◽

2021 ◽

Vol 9 (3) ◽

pp. 132

Author(s):

Lezley-Anne Hanna ◽

Alana Murphy ◽

Maurice Hall ◽

Rebecca Craig

Keyword(s):

Emergency Contraception ◽

Self Care ◽

Pharmacy Students ◽

Single Institution ◽

Self Medication ◽

Over The Counter ◽

Otc Medicines ◽

Practice Methods ◽

Identifiable Data

Background: The aim was to investigate pharmacy students’ views on the role of the pharmacist in facilitating self-care with over-the-counter (OTC) medicines, particularly in light of new roles, and establish personal practice. Methods: Final year pharmacy students at Queen’s University Belfast were invited to participate. Data were collected via a pre-piloted questionnaire, distributed at a compulsory class (only non-identifiable data were requested). Descriptive statistics were performed, and non-parametric tests were employed for inferential statistical analysis (responses by gender). Results: The response rate was 87.6% (78/89); 34.6% (27/78) males and 65.4% (51/78) females. Over a third [34.6% (27/78)] reported using OTC medicines about once a month. All appreciated the importance of an evidence-based approach to optimize patient care. Most [(96.2% (75/78)] deemed OTC consultations should remain a fundamental responsibility of pharmacists and 69.2% (54/78) thought OTC consultations have the potential to be as complex as independent pharmacist prescribing. Females felt more confident recommending OTC emergency contraception than males (p = 0.002 for levonorgestrel and p = 0.011 for ulipristal acetate). Many [61.5% (48/78)] considered more medicines should not be deregulated from prescription-only status. Conclusions: Data from this single institution suggests that enabling self-medication is an important part of practice but there were confidence issues around deregulations.

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Tackling the challenges of nanomedicines: are we ready?

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxab048 ◽

2021 ◽

Author(s):

John B Hertig ◽

Vinod P Shah ◽

Beat Flühmann ◽

Stefan Mühlebach ◽

Gunar Stemer ◽

...

Keyword(s):

Complex Nature ◽

Pharmaceutical Sciences ◽

Patient Benefit ◽

World Congress ◽

Clinical Safety ◽

Hospital Pharmacists ◽

Drug Products ◽

Regulatory Bodies ◽

Regulatory Landscape

Abstract Purpose This review provides an overview of the proceedings of the symposium “Tackling the Challenges of Nanomedicines: Are We Ready?” organized by the International Pharmaceutical Federation (FIP) Hospital Pharmacy Section and Non-Biological Complex Drugs (NBCDs) Working Group at the 2019 FIP World Congress of Pharmacy and Pharmaceutical Sciences. Debate centered on reasons underlying the current complex regulatory landscape for nanomedicines and their follow-on products (referred to as nanosimilars) and the pivotal role of hospital pharmacists in selecting, handling, and guiding usage of nanomedicines and nanosimilars. Summary The evaluation and use of nanomedicines are recognized among scientific, pharmaceutical, and regulatory bodies as complex. Interchangeability and substitutability of nanomedicines and nanosimilars are confounded by a lack of pharmaceutical and pharmacological equivalence, reflecting the inherent complex nature of these drug products and manufacturing processes. Consequences include implications for clinical safety and efficacy and, ultimately, comparability. Local regulatory approvals of some nanomedicines have occurred, but there is no standard to ensure streamlined evaluation and use of consistent measures of therapeutic equivalence of reference products and their nanosimilars. Hospital pharmacists are expected to be experts in the selection, handling, and substitution of nanomedicines and familiarize themselves with the limitations of current methods of assessing pharmaceutical and clinical equivalence of nanosimilars in order to ensure informed formulary decision-making and eventual patient benefit. Conclusion Supportive guidance for pharmacists focusing on the substitutability and/or interchangeability of nanomedicines and their nanosimilars is needed. Current FIP guidance for pharmacists on therapeutic interchange and substitution should be extended to include nanomedicines and nanosimilars.

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