Brief Profile :
The USFDA or FDA is a federal agency formed in 1906, making it the oldest comprehensive consumer protection agency. As the name suggests, this is an agency within the Department of Health and Human Services. This agency’s headquarters is at White Oak, Maryland, and it is headed by the United States Commissioner of Food and Drugs. This agency has 223 field offices and 13 laboratories located throughout the 50 states, including the United States Virgin Islands and Puerto Rico. 1
Responsibilities of USFDA
- The main responsibility of this agency is the protection and promotion of public health throughout the United States.
- It is also concerned with the supervision of food safety, tobacco products, dietary supplements, prescription, and over–the–counter ( OTC ) medications. Medical devices, products that emit radiation, cosmetics, food and animal feed, and veterinary products are some of the other products this agency supervises.
- Its other roles involve regulating the manufacturing, marketing, and distribution of tobacco products to protect public health and reduce tobacco use by minors.
- Advancing public health by helping speed innovations that improve the efficacy, safety, and affordability of medical products is one of the FDA’s key responsibilities.
- USFDA also helps keep the public well–informed and updated about the medicinal products they use and foods that maintain and improve health.
- In addition to this, it is involved in developing medicinal products that respond to deliberate and nationally emerging public health threats.
Importance of USFDA
- The FDA’s regulatory authority includes the regulation of various products – foods, infant formulas, prescription and non – prescription drugs, biologics, medicinal products, and cosmetics.
- It extensively scrutinizes new drugs before approving their use in a new drug application ( NDA ). FDA-approved drugs are considered safe and effective when consumed by the patient as directed.
- In emergencies, such as pandemic or epidemic outbreaks, the FDA hastens the approval process by limiting the studies needed for the approval process. This emergency use authorization ( EUA ) is given for drugs used to treat rare conditions for which no existing remedies are satisfactory.
- USFDA also protects consumers from getting deceived by fraudulent and misleading advertisements regarding drugs by stopping unfair practices in the marketplace and regulating advertising types.
- The FDA also carries out manufacturing, distribution, and dispensing of legally produced drugs of abuse.
- Research and development activities to develop and support technology and standards for its regulatory role further enhances its importance in society.
Other Relevant Information :
- FDA regulates over 78 % of the U.S food supply and also oversees around $ 2.8 trillion in consumption of food, medicinal products, and tobacco.
- The public can easily access data about drugs, medical devices, and other products approved by the FDA via the “openFDA” project.
- The FDA regulates almost every aspect of prescription drugs but only focuses on the regulation of labeling and safety in the case of cosmetics.
- It also practices regulatory shaming by the online publication of non – compliance, warning letters, and shaming lists. This is done to give the firms a chance to rectify their shortcomings.