- FDA or food and drug Administration is the federal agency in the USA running under the Department of Health and Human Services.
- It is responsible for protecting and promoting public health through the control and supervision of food safety, dietary products, prescription, over the counter drugs, Schedule H drugs, vaccines, medical devices, cosmetics and all the products related to pharmacy and food and health industry.
- FDA was formed in June 30,1906.It has headquarters which lies in the Maryland, USA and which holds currently more than 15000 employees.
- Official site : https://www.fda.gov/
It includes various agencies like :-
- Centre for drug evaluation and research
- Centre for food safety and applied nutrition
- Office of criminal investigation
- Centre for tobacco products
- Centre for veterinary medicine
- Centre for toxicology research
And many more…….
The commissioner of the FDA is appointed by the president with the advice of the Senate. The commissioner reports to the secretary of health and human services.
The FDA’s primary focus Is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of diseases in the contexts varying from household pets to human sperm donated for use in assisted reproduction.
The FDA’s headquarters is located in White Oak, Maryland. The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
The FDA carries out research and development activities to develop technology and standards that support its regulatory role, with the objective of resolving scientific and technical challenges before they become impediments. The FDA’s research efforts include the areas of biologics, medical devices, drugs, women’s health, toxicology, food safety and applied nutrition, and veterinary medicine.
SIGNIFICANCE OF FDA IN THE FIELD OF DRUGS AND MEDICINE
FDA has major actions in the field of drugs as it –
- It is constantly involved in the process of new drug development
- It constantly monitors the effects of particular drug in the society by playing a major role in the pharmacovigilance.
- It may also erase, resist or simply warns the use of drug whenever Necessary.
★ FDA role in new drug development:-
The first involvement of the FDA in the development process comes when the drug sponsor submits an IND application. Approval must be awarded by both the FDA and the local institutional review board in order for testing in humans to commence. The primary purpose of the IND is to ensure the safety of study participants.
* The IND application presents information collected during preclinical testing in three broad categories:
- it offers data on the toxicity and pharmacology of the drug when administered to animals in order to confirm that, within reason, the drug can be safely administered to humans.
- it discusses the manufacturing process of the drug to allow the FDA to assess whether the manufacturer can safely produce batches of the drug with a consistent composition.
- it introduces the proposed clinical study protocols and the qualifications of the investigators overseeing the trials as well as presents the informed consent documents that will be provided to study participants.
If the investigators are not informed that the application has been denied or that a clinical hold has been established within 30 days of submission, then phase I trials may begin. An official approval notification is not typically issued; thus, an approval can be assumed in the absence of a notification otherwise within 30 days. Communication between the drug sponsor and the FDA is usually ongoing from the time at which the IND application is submitted. However, there are also formal meetings that generally occur before and after the phase III studies. A review meeting is conducted following the completion of phase II trials in order to discuss the data acquired thus far and to agree on design protocols for phase III trials. Following phase III trials, a pre–new drug application (NDA) meeting to discuss the imminent NDA submission is held. The NDA is the final formal request made to the FDA for drug approval and, if accepted, the drug can then be marketed in the US. Within the NDA, the drug sponsor includes all animal and human trial data with the appropriate analysis results. The FDA then must decide, on the basis of these data, whether the drug is able to provide benefits that outweigh its known or potential risks to its intended population. The FDA has 60 days to assess the completed application and formally file it for review. Once filed, the FDA aims to act on the NDA within 10 months. As part of this review, the FDA is also required to examine the professional labeling of the drug and inspect the facility where the drug is manufactured. An FDA approval at this stage means that the drug has met the necessary standards for safety and efficacy data, labeling, and manufacturing.
★ FDA role in the pharmacovigilance of a particular drug
The pharmacovigilance process was developed by national drug regulatory agencies, like the US Food and Drug Administration (FDA), to ensure safe and effective medicines for the general public. Pharmacovigilance principally involves the identification and evaluation of safety signals associated with the use of a medicinal product, and refers to ‘all scientific and data gathering activities relating to the detection, assessment, and understanding of adverse events’. The process of risk assessment during a medicine’s clinical development, including the identification of AEs as adverse reaction rates for drug exceed the placebo rate, has been reviewed in detail and is well understood. The process of assessing medicinal product risk in the post marketing setting is complicated by the lack of a placebo comparator and use by patients with comorbid conditions and those being treated with concomitant medicinal products. Safety signals, defined by the FDA as adverse effects that exceed what would be expected to be associated with a product’s use based on what has been reported in clinical trials, may arise in the post marketing setting from passive and active surveillance, or from additional preclinical and clinical data, including those from other products in the same therapeutic class. Identification of a safety signal necessitates additional investigation to determine treatment causality and whether the safety signal represents a potential safety risk that requires action and communication to the patient and HCPs.
- All the government colleges and hospitals and even doctors should continue monitoring any Adverse effects produce and should report to the FDA.
- All Adverse effects reports are submitted electronically to the FDA Adverse Event Reporting System (FAERS) database within a specified time period.
- Also, drug manufacturers are required by the FDA to conduct ongoing safety evaluations and periodically review and analyze their safety databases. These requirements and regulations provide a mechanism for the FDA to detect early warning signs of potential threats to public health.
- Now on the basis of the data provided to the FDA, the investigators have to decide weather the adverse effects are serious or not. Based on these activities, the FDA decide weather to continue the drug or not.
- If the adverse effect is mild then most of the time they just release a black box warning on the box of the durg for the public to know the adverse effects it may produce.
- If FDA examiners find serious effects, then they may decide to terminate the use of drug by giving instructions to the manufacturers.
