Parents' decision following the Food and Drug Administration recommendation: the case of over-the-counter cough and cold medication

A physician asked the Food and Drug Administration (FDA) for information regarding podophyllum. He had under his care an infant born with phocomelia manifested by bilateral absence of the radii. During her pregnancy, the child's mother had occasionally taken a laxative which contained podophyllum as one of its active ingredients. This inquiry led to an intensive search for available information on this subject. The discussion below is a summary of this information. From the data it was determined that podophyllum is too toxic a drug to be used as a laxative, especially since much safer laxatives are available. The FDA Advisory Review Panel on Over-the-Counter (OTC) Laxative, Antidiarrheal, Emetic and Antiemetic Drug Products, in a recently completed independent evaluation, similarly concluded that podophyllum resin is an unsafe laxative.

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Comprehension Testing for OTC Drug Labels: Goals, Methods, Target Population, and Testing Environment

Journal of Public Policy & Marketing ◽

10.1177/074391569801700109 ◽

1998 ◽

Vol 17 (1) ◽

pp. 86-96 ◽

Cited By ~ 11

Author(s):

Louis A. Morris ◽

Karen Lechter ◽

Michael Weintraub ◽

Debra Bowen

Keyword(s):

Drug Administration ◽

Food And Drug Administration ◽

Target Population ◽

Low Literacy ◽

Over The Counter ◽

Testing Environment ◽

Complex Products ◽

Drug Products ◽

Label Information

Drug products may be switched from precription (Rx) to over-the-counter (OTC) status if labeling can be written that ensures that the label information is comprehensible to ordinary consumers, including persons with low literacy ability, under normal conditions of purchase and use. The Food and Drug Administration has been working with sponsors to develop methods to test consumer comprehension of proposed OTC product labels. The authors discuss several conceptual and operational elements of comprehension testing, focusing on the goals, methods, appropriate target audience, and testing environment. The authors also examine areas in need of further research and debate. As more complex products are considered for OTC status, it is even more important to ensure that OTC labels are comprehensible. As understanding and the validity of methods to evaluate consumer comprehension improve, so should the quality of labels offered to consumers.

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Regulation of Topical Antimicrobials: History, Status and Future Perspective

Infection Control and Hospital Epidemiology ◽

10.1086/645935 ◽

1989 ◽

Vol 10 (11) ◽

pp. 505-508 ◽

Cited By ~ 4

Author(s):

Mary K. Bruch ◽

Elaine Larson

Keyword(s):

Drug Administration ◽

Antimicrobial Agents ◽

Food And Drug Administration ◽

Current Status ◽

Future Perspective ◽

Over The Counter ◽

Topical Antimicrobials ◽

Hospital Use

AbstractAntimicrobial agents used as disinfectants and antiseptics are increasing in epidemiologic importance. The regulation of topical antiseptics has ranged from nonexistent, lax and confusing to inclusion in the Food and Drug Administration (FDA) over-the-counter (OTC) review of drug ingredients. This article simplifies the complex history, current status and future possibilities for the hospital use of topical antiseptic products.

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Over-the-Counter Progesterone Cream Produces Significant Drug Exposure Compared to a Food and Drug Administration-Approved Oral Progesterone Product

The Journal of Clinical Pharmacology ◽

10.1177/0091270005276621 ◽

2005 ◽

Vol 45 (6) ◽

pp. 614-619 ◽

Cited By ~ 11

Author(s):

Anne C. Hermann ◽

Anne N. Nafziger ◽

Jennifer Victory ◽

Robert Kulawy ◽

Mario L. Rocci ◽

...

Keyword(s):

Drug Administration ◽

Drug Exposure ◽

Food And Drug Administration ◽

Over The Counter

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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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Television Advertising of Nonprescription Medicines: The Case for the Defendant

Journal of Drug Issues ◽

10.1177/002204267600600116 ◽

1976 ◽

Vol 6 (1) ◽

pp. 85-90 ◽

Cited By ~ 1

Author(s):

James D. Cope

Keyword(s):

Drug Abuse ◽

Drug Administration ◽

Food And Drug Administration ◽

Television Advertising ◽

Over The Counter ◽

Ongoing Work ◽

Otc Medicines ◽

Over The Counter Medicines

When critics raised suggestions that a link existed between drug abuse and the advertising of over-the-counter (OTC) medicines, the Proprietary Association commissioned independent studies to determine if there were truth to the allegations. “The weight of the evidence refutes the alleged relationship between advertising and drug abuse,” concludes the author of this paper. He also outlines the ongoing work of the OTC Review Panels, commissioned by the Food and Drug Administration, to evaluate ingredients in all over-the-counter medicines available to American consumers.

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Hearables: eLearning in the Workplace

EDEN Conference Proceedings ◽

10.38069/edenconf-2019-ac-0012 ◽

2019 ◽

pp. 97-102

Author(s):

Rory McGreal

Keyword(s):

Artificial Intelligence ◽

Drug Administration ◽

Hearing Aids ◽

Hearing Aid ◽

Food And Drug Administration ◽

Personal Digital Assistant ◽

Hearing Impaired ◽

The Internet ◽

Over The Counter ◽

The Usa

Hearables, a term first coined by Hunn (2014), are wireless smart micro-computers with artificial intelligence that incorporate both speakers and microphones. They fit in the ears and can connect to the internet and to other devices; they are designed to be worn daily. These devices, such as the Bragi Dash, Vinci and Bose Hearphone are now appearing on the market, which is expected to exceed $40 billion in the USA by 2020 (Omnicom, 2018). Hearables are not headphones, nor hearing aids, nor ear plugs, although they could take on the affordances of any of these devices (Banks, 2018). Headphones are designed for listening to music. Hearing aids are designed as an aid for the hearing impaired. Ear plugs reduce unwanted sounds by cancelling noise. Hearables offer comparable features and additionally provide users with a microphone and connectivity to the internet supporting telephony and personal digital assistant (PDA) services (Computational Thinkers, n.d.). Prior to 2017, in the USA, such devices required the approval of the Food and Drug Administration. This approval is no longer required for hearables, as they are no longer considered to be medical hearing aids (Over the Counter Hearing Aid Act, 2017). This paves the way for the expansion in the market of significantly lower-priced hearables, undercutting the expensively-priced hearing aid market.

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