The History of the FDA's Fight for Consumer Protection and Public Health, by US Food and Drug Administration

2019 ◽  
Vol 28 (1) ◽  
pp. 199-202
Author(s):  
Elizabeth Semler
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Consumer Protection ◽  
Food And Drug Administration ◽  
History Of

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date

2021 ◽  
pp. 174077452110505
Author(s):  
Dionne Price ◽  
John Scott
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Trial Design ◽  
Drug Evaluation ◽  
Food And Drug Administration ◽  
Medical Product ◽  
Global Public Health ◽  
Multiple Sources ◽  
Meeting Program ◽  
The U.S

Background The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration have been leaders in advancing science to protect and promote public health by ensuring that safe and effective drugs and biological products are available to those who need them. Recently, new therapeutic discoveries, increased understanding of disease mechanisms, the need for innovation to optimally use resources, and global public health crises have led to an evolving drug development landscape. As a result, the U.S. Food and Drug Administration and medical product developers are faced with unique challenges and opportunities. The U.S. Food and Drug Administration is proactively meeting the challenges of this evolving landscape through various efforts, including the Complex Innovative Trial Design Pilot Meeting Program. Our focus, here, will be on the pilot meeting program. Methods The U.S. Food and Drug Administration has defined a process to facilitate the implementation of the Complex Innovative Trial Design Pilot Meeting Program. The process is transparent and outlines the steps and timeline for submission, review, and meetings. Results Five submitted meeting requests have been selected for participation in the Complex Innovative Trial Design Pilot Meeting Program. Conclusion The pilot meeting program has been successful in further educating stakeholders on the potential uses of complex innovative designs in trials intended to provide substantial evidence of effectiveness. The selected submissions, thus far, have all utilized a Bayesian framework. The reasons for the use of Bayesian approaches may be due to the flexibility provided, the ability to incorporate multiple sources of evidence, and a desire to better understand the U.S. Food and Drug Administration perspective on such approaches. We are confident the pilot meeting program will have continued success and impact the collective goal of bringing safe and effective medical products to patients.

Children’s Fruit “Juice” Drinks and FDA Regulations: Opportunities to Increase Transparency and Support Public Health

2020 ◽  
Vol 110 (6) ◽  
pp. 871-880 ◽  
Author(s):  
Jennifer L. Pomeranz ◽  
Jennifer L. Harris
Keyword(s):  
Public Health ◽  
Vitamin C ◽  
Drug Administration ◽  
Fruit Juice ◽  
Food And Drug Administration ◽  
Federal Law ◽  
Added Sugar ◽  
Labeling Regulations ◽  
Wide Range ◽  
Fda Regulations

Objectives. To compare children’s drink products that contain or purport to contain juice and evaluate labels in light of US Food and Drug Administration (FDA) regulations. Methods. In 2019, we analyzed federal law for drinks that contain or purport to contain juice by using LexisNexis and FDA’s Web site, identified top-selling children’s “juice” drinks in fruit punch flavors, gathered labels in store and online, and extracted data from the principal display and information panels. Results. FDA regulations permit a wide range of names, claims, and fruit vignettes on drinks that contain or purport to contain juice, reflecting the product’s flavor and not necessarily its ingredients. We identified 39 brands of children’s drinks, including 100% juice (n = 7), diluted juices (n = 11), juice drinks (n = 8), fruit-flavored drinks (n = 8), and flavored waters (n = 5), with nonuniform statements of identity; vitamin C and low-sugar claims; and fruit vignettes representing 19 fruits. Many products contained added sugar and nonnutritive sweeteners but little to no juice. Conclusions. Principal display panels rendered it difficult to differentiate among product types, identify those with added sweeteners, and distinguish healthier products. Revised labeling regulations are warranted to support public health.

Covert Administration of Benzyl Alcohol to Neonates

PEDIATRICS ◽  
1982 ◽  
Vol 70 (3) ◽  
pp. 509-510
Author(s):  
K. Gregory Humma
Keyword(s):  
Public Health ◽  
Renal Failure ◽  
Metabolic Acidosis ◽  
Benzyl Alcohol ◽  
Drug Administration ◽  
Premature Infants ◽  
Public Health Service ◽  
Food And Drug Administration ◽  
Intracranial Hemorrhages ◽  
Cns Depression

On May 28, 1982, the Food and Drug Administration issued a letter to physicians and hospital pharmacists concerning the apparent toxicity of benzyl alcohol in premature infants (H. M. Meyer, Jr, Director, Bureau of Drugs and Biologics, Public Health Service, Food and Drug Administration, Rockville, MD). Cases were described in which neonates weighing less than 2,500 gm had died from a syndrome consisting of metabolic acidosis, CNS depression, respiratory distress, hypotension, renal failure, and sometimes seizures and intracranial hemorrhages.

Contingency Medical Countermeasures for Mass Nerve-Agent Exposure: Use of Pharmaceutical Alternatives to Community Stockpiled Antidotes

2018 ◽  
Vol 13 (03) ◽  
pp. 605-612 ◽  
Author(s):  
Michael D. Schwartz ◽  
Mark E. Sutter ◽  
Derek Eisnor ◽  
Mark A. Kirk
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Homeland Security ◽  
Food And Drug Administration ◽  
Medical Toxicology ◽  
Chemical Exposure ◽  
Nerve Agent ◽  
Government Procurement ◽  
Gamma Aminobutyric Acid ◽  
Medical Countermeasures

ABSTRACTHaving sufficient medical countermeasures (MCMs) available for the treatment of acetylcholinesterase-inhibiting nerve agent poisoned patients following a mass chemical exposure is a challenge for communities. After stockpiles containing auto-injectors are exhausted, communities need to be aware of alternative pharmaceutical options. The Department of Homeland Security Chemical Defense Program convened a federal interagency working group consisting of first responders, clinicians, and experts from the fields of medical toxicology, pharmacology, and emergency management. A literature review of pharmaceutical alternatives for treating nerve agent toxicity was performed. Pharmaceuticals that met the federal Public Health Emergency Medical Countermeasures Enterprise Product Specific Requirements were prioritized. Food and Drug Administration approval for one indication, market availability, and alignment to government procurement strategy were considered. This article summarizes the literature on comparative pharmacokinetics and efficacy against nerve agents (where available) of Food and Drug Administration approved drugs with muscarinic acetylcholine receptor antagonist and gamma-aminobutyric acid receptor agonist effects. This work is intended to serve as a resource of pharmaceutical options that may be available to communities (ie, emergency managers, planners, clinicians, and poison centers) when faced with a mass human exposure to a nerve agent and inadequate supplies of MCMs. (Disaster Med Public Health Preparedness. 2019;13:605-612)

Sign in / Sign up

Export Citation Format

Share Document