U.S. FDA: Food and Drug Administration Transparency Task Force

Ian C. Langtree - Writer/Editor for Disabled World (DW)
Published: 2010/02/04 - Updated: 2024/03/02
Publication Type: Informative
Topic: Pharmaceuticals - Publications List

Page Content: Synopsis - Introduction - Main

Synopsis: Outlines the role of the U.S. Food and Drug Administration and the FDA Transparency Task Force blog. The FDA is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States of America.

Introduction

The FDA is an agency within the U.S. Department of Health and Human Services. It consists of six product centers, one research center, and two offices. The FDA is the government agency responsible for regulating food, dietary supplements, drugs, cosmetics, medical devices, biologics and blood products in the United States of America.

Main Item

The FDA is responsible for protecting American public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

The U.S. FDA Regulates:

• Foods, except for most meat and poultry products, which are regulated by the U.S. Department of Agriculture
• Food additives
• Infant formulas
• Dietary supplements
• Human drugs
• Vaccines, blood products, and other biologics
• Medical devices, from simple items like tongue depressors, to complex technologies such as heart pacemakers
• Electronic products that give off radiation, such as microwave ovens and X-ray equipment
• Cosmetics
• Feed, drugs, and devices used in pets, farm animals, and other animals
• Tobacco products

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Reporting Problems With FDA Regulated Products

There are several ways you can report problems to FDA:

• Call the FDA Consumer Complaint Coordinator for your geographic region.
• Report to FDA's MedWatch program any product problems or unexpected side effects (adverse events) that occur while using drugs, medical devices, dietary supplements, infant formulas, cosmetics, and blood products and other biologics (except for vaccines) either online, by regular mail, by fax, or by phone.
• Report a vaccine-related illness or injury to the Vaccine Adverse Event Reporting System (VAERS) or call 1-800-822-7967 to request a reporting form.

FDA Transparency Task Force

On June 2nd, 2009, the Food and Drug Administration (FDA) announced the formation of a task force to develop recommendations for enhancing the transparency of the FDA's operations and decision-making process. The task force, chaired by Principal Deputy Commissioner Joshua Sharfstein, M.D., sought to:

• Seek public input on issues related to transparency.
• Identify appropriate tools and new technologies for informing the public.
• Submit a written report to the commissioner on the Transparency Task Force's findings and recommendations.
• Recommend legislative or regulatory changes, if appropriate, to improve the FDA's ability to provide information to the public.
• Recommend ways that the agency can better explain its operations compatible with the appropriate protection of confidential information.
• Identify information the FDA should provide about specific agency operations and activities, including enforcement actions and product approvals.
• Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision-making to the public.
• Recommend changes to the FDA's current operations, including internal policies and guidance, to improve the agency's ability to provide information to the public in a timely and effective manner.

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Author Credentials: Ian was born and grew up in Australia. Since then, he has traveled and lived in numerous locations and currently resides in Montreal, Canada. Ian is the founder, a writer, and editor in chief for Disabled World. Ian believes in the Social Model of Disability, a belief developed by disabled people in the 1970s. The social model changes the focus away from people's impairments and towards removing barriers that disabled people face daily. To learn more about Ian's background, expertise, and achievements, check out his bio.