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

1974 ◽  
Vol 4 (3) ◽  
pp. 291-296 ◽  
Author(s):  
Henry Simmons

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.

1992 ◽  
Vol 22 (2) ◽  
pp. 265-276 ◽  
Author(s):  
Marianne R. Watts ◽  
Judith D. Wilkenfeld

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.


1974 ◽  
Vol 4 (3) ◽  
pp. 223-226 ◽  
Author(s):  
Donald L. Kanter

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.


2020 ◽  
Vol 10 (10) ◽  
pp. 736
Author(s):  
Stefania Chiappini ◽  
Fabrizio Schifano

Recently, a range of prescription and over-the-counter (OTC) drugs have emerged as being used recreationally, either on their own or in combination with other substances, both licit and illicit, including new psychoactive substances (NPS). Among them, the misuse of prescription drugs involves not only traditionally recorded substances, such as benzodiazepines and opioid pain relievers, but also gabapentinoids (e.g., pregabalin and gabapentin); some antidepressants, e.g., bupropion and venlafaxine; some second-generation antipsychotics, e.g., quetiapine and olanzapine. Moreover, the use of some OTC for recreational purposes appears on the increase, especially in vulnerable categories such as young people/youths, including the use of high dosages of the antidiarrheal loperamide; first-generation antihistamines, e.g., promethazine, cyclizine, and diphenhydramine; cough and cold preparations containing dextromethorphan and/or codeine. In this context, the role of the Internet has rapidly increased, playing a significant role both in the diffusion of emerging trends of drug misuse among users and experimenters, and the marketing, sale, and distribution of drugs through online pharmacies. This phenomenon within the context of a rapidly modifying drug scenario is a globally recognized health problem, determining severe adverse consequences, including fatalities, and represents a challenge for clinicians in general, psychiatrists, public health, and drug-control policies.


1974 ◽  
Vol 4 (3) ◽  
pp. 232-237
Author(s):  
Thomas J. Donegan

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.


1976 ◽  
Vol 6 (1) ◽  
pp. 99-104
Author(s):  
Thomas J. Donegan

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.


Pharmacia ◽  
2019 ◽  
Vol 66 (3) ◽  
pp. 135-140
Author(s):  
Tetiana Ryvak ◽  
Oksana Denysiuk

An assessment of the opinion of a certain cohort of the population on the role of drug advertising in the choice of non-prescription drugs for self-treatment was conducted. According to the questionnaire survey, it has been established that advertising affects the choice of drug for self-treatment 26.0% of the polled. Despite the fact that the majority of respondents indicate that there is no influence of drug advertising, 62.8% of them buy self-medication drug sabout which they learned from advertising. Thus, our scientific hypothesis about the presence of the direct influence of drug advertising on the commitment of patients to pharmacotherapy is confirmed. The majority of respondents (90.0%) do not consider advertising of drugs to be effective and safe, and 61.0% say that drug advertising contains contradictory and incomprehensible information. Almost all respondents (88.0%) are convinced that drug advertising is not always objective and fair. At the same time, according to 50.0% of respondents, the volume of drug advertising in Ukraine should be reduced, 22.0% of respondents believe that advertising of drugs should be prohibited.


Pharmacy ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 132
Author(s):  
Lezley-Anne Hanna ◽  
Alana Murphy ◽  
Maurice Hall ◽  
Rebecca Craig

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.


1999 ◽  
Vol 25 (1) ◽  
pp. 149-167
Author(s):  
Tamar V. Terzian

The Food and Drug Administration (FDA) regulates the promotion of pharmaceutical products. The FDA's regulations issued under the Food, Drug and Cosmetic Act (FDCA) require that prescription drug broadcast advertisements include the following: (1) a major statement of the product's risks in at least the audio part of the advertisement; and (2) that an adequate provision for the dissemination of the approved package labeling be made “in connection with the broadcast presentation,” if the brief summary is not also part of the advertisement. Under the FDCA, the brief summary provides information concerning the major risks of the drug.


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