Food and Drugs Administration.pptx

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2. C o n t e n t Introduction History Responsibility of USFDA Organization Constitution FDA Advisory committee Scope and Fundings Legal Authority of FDA Mission What USFDA regulates? What USFDA does not regulates? Recent Update References 2

3. FDA Logo Formed Preceding agencies Agency overview 1906 Food, Drug, and Insecticide Administration (July 1927 to July 1930)        Jurisdiction Head quarters Employees Annual budget Agency executive Parent agency Website Bureau of Chemistry (July 1901 through July 1927) Division of Chemistry, USDA (Established 1862) Federal government of the United States 10903 New Hampshire Ave, Silver Spring, MD 20903 11,516 $2.3 billion Margaret A. Hamburg, Commissioner of Food and Drugs Department of Health and Human Services fda.gov 3

4. INTRODUCTION • • • • The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics. The FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include sanitation requirements on interstate travel and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. 4

5. HISTORY OF FDA In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate. The act applied penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopoeia or the National Formulary . The act also banned "misbranding" of food and drugs. The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry. Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, as well as by the creation of the Board of Food and Drug Inspection and the Referee Board of Consulting Scientific Experts as separate organizations within the USDA in 1907 and 1908 respectively. 5

6. A 1911 Supreme Court decision ruled that the 1906 act did not apply to false claims of therapeutic efficacy in response to which a 1912 amendment added "false and fraudulent" claims of "curative or therapeutic effect" to the Act's definition of "misbranded.“ However, these powers continued to be narrowly defined by the courts, which set high standards for proof of fraudulent intent. In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later. 6

7. RESPONSIBILITY OF FDA Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective. Protecting the public from electronic product radiation. Assuring cosmetics and dietary supplements are safe and properly labeled Regulating tobacco products. Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health. FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions. 7

8. Margaret A. Hamburg, M.D. Commissioner Of Food and Drugs The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. The 21st and current Commissioner is Dr. Margaret A. Hamburg. She has served as Commissioner since February 2009. FDA con sists of six product centers, one research center, and two offices – Center for Biologics Evaluation and Research - which regulates products such as vaccines, blood, and gene therapy. Center for Devices and Radiological Health - which regulates medical devices ranging from thermometers to kidney dialysis machines, and electronic products that give off radiation, such as microwave ovens. ORGANIZATION OF FDA 8

9. Center for Drug Evaluation and Research - which regulates over-the-counter and prescription medications. Center for Food Safety and Applied Nutrition- which regulates most foods (except meat and poultry, which are regulated by the U.S. Department of Agriculture), food additives, infant formulas, dietary supplements, and cosmetics. Center for Tobacco Products - which regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Center for Veterinary Medicine _ which regulates feed and drugs and devices used in pets, farm animals, and other animals. 9

10. National Center for Toxicological Research- which supports FDA’s product centers by providing innovative scientific technology, training, and technical expertise. Office Of Regulatory Affairs- which conducts inspections and enforces FDA regulations. Office of the Commissioner- which provides leadership and direction to FDA’s product centers, research center, and Office of Regulatory Affairs. 10

11. CONSTITUTION • USFDA has over 11516 employees, located in 167 U.S. cities. Among its staff, FDA has chemists, microbiologist, and other scientists, as well as investigators and inspectors who visit 16000 facilities a year as part of their oversight of the business that FDA regulates . • The FDA has its headquarters at Silver Spring, Maryland and has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. • In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. 11

12. 1 2 • As of Oct. 1, 2009, FDA employs the following numbers of people in its centers/offices:  Center for Biologics Evaluation and Research (CBER) 946  Center for Drug Evaluation and Research (CDER) 2,889  Center for Devices and Radiological Health (CDRH) 1,203  Center for Food Safety and Applied Nutrition (CFSAN) 877  Center for Tobacco Products (CTP) 194

13. FDA ADVISORY COMMITTEE Advisory committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, vaccines and other biological products, medical devices, and food. In general, advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be added for individual committee meetings as needed. Although the committees provide advice to the agency, FDA makes the final decisions. 13

14. H o w D O E S A N I N D I V I D UA L B E C O M E A MEMBER OF AN FDA ADVISORY COMMITTEE? Professio n al societies; industry, consumer, and patient advocacy groups; or other interested people may nominate scientific members and consumer, industry, and patient representatives. In addition, individuals who want to serve on a committee may nominate themselves. FDA requests that candidates provide detailed information regarding financial holdings, employment, research grants and contracts, and other potential conflicts of interest that may rule out membership. The Food and Drug Administration, to assist in its mission to protect and promote the public health, uses 49 committees and panels to obtain independent expert advice on scientific, technical, and policy matters. 14

15. SCOPE AND FUNDING The FDA regulates more than $1 trillion worth of consumer goods, about 25% of consumer expenditures in the United States. This includes $466 billion in food sales, $275 billion in drugs, $60 billion in cosmetics and $18 billion in vitamin supplements. Much of the expenditures is for goods imported into the United States; the FDA is responsible for monitoring a third of all imports. Sagar Kishor Savale 15 04/28/16

16. LEGAL AUTHORITY Of FDA Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act,(first passed in 1938 and extensively amended since) and are codified in Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as many others. In many cases these responsibilities are shared with other federal agencies. Important enabling legislation of the FDA includes : 1902 – Biologics Control Act 1906 – Pure Food and Drug Act 1938 – Federal Food, Drug, and Cosmetic Act 1944 – Public Health Service Act 04/2 8 /16  16 1951 Sa – ga F r o Ki o sh d o , r S D av r a u le g, and Cosmetics Act Amendments

17.  1962 – Food, Drug, and Cosmetics Act Amendments 1966 – Fair Packaging and Labeling Act 1976 – Medical Device Regulation Act 1987 – Prescription Drug Marketing Act 1988 – Anti–drug Abuse Act 1990 – Nutrition Labeling and Education Act 1992 – Prescription Drug User Fee Act Sagar Kishor Savale 17 04/2 8 /16

18. 1994 – Dietary Supplement Health and Education Act 1997 – Food and Drug Administration Modernization Act 2002 – Bioterrorism Act 2002 – Medical Device User Fee and Modernization Act (MDUFMA) 2003 – Animal Drug User Fee Act 2007 – Food and Drug Administration Amendments Act of 2007 2009 – Family Smoking Prevention and Tobacco Control Act 18

19. MISSION OF FDA • • • To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner. With respect to such products, protect the public health by ensuring that the food are safe, Wholesome, sanitary, and properly labelled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labelled, and public health and safety are protected from the electronic product radiation. Participates through appropriate process with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate arrangements. 19

20. WHAT USFDA REGULATES? • • • • • • • • • • • Biologics Food additives Dietary supplements Product standards and develop improved testing's methods Cosmetics Labeling OTC and prescription drug labeling Drug manufacturing standards Foods Safety of all food products ( except meat and poultry) Medical devices from simple items like tongue depressors, to complex technologies such as heart pacemakers 20

21. Drugs (OTC and prescription drug ) Radiation-Emitting Electronic Products • • • • Radiation safety performance standards for microwave ovens, television receivers, diagnostic x-rays equipment, cabinet x-ray system ( such as baggage x-rays at airports ), Laser products, ultrasonic therapy equipment, mercury vapour lamps Veterinary drugs and devices 21

22. WHAT USFDA DOES NOT REGULATE ? • Advertising - except for prescription drugs, medical devices, and tobacco products • Alcohol beverages • Consumer Products - paint, child-resistant packages, baby toys, and household appliances (except for those that give off radiatio n) • Drugs of Abuse - heroin and marijuana • Health Insurance • Meat and Poultry - except for game meats, such as venison, ostrich, an snake 22

23. • P e s ti c i d e s • Restaurants and Grocery Stores Water FDA shares the responsibility for regulating these products with other government agencies : pesticides (FDA, the U.S. Department of Agriculture, and the Environmental Protection Agency ) • water (FDA regulates the labeling and safety of bottled water, while the Environmental Protection Agency develops national standards for drinking water from municipal water supplies) 23

24. RECENT UPDATE …… The FDA currently has regulatory oversight over a large array of products that affect the health and life of American citizens. As a result, the FDA's powers and decisions are carefully monitored by several governmental and non- governmental organizations. In 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA. Nine FDA scientists appealed to then president-elect Barack Obama over pressures from management, experienced during the George W. Bush presidency, to manipulate data, including in relation to the review process for med Sa i g c a a r l K d ish e o v r i S c a e va s l . e

25. FDA Food Safety Modernization Act The FDA Food Safety Modernization Act is a federal statute signed into law by President Barack Obama on January 4, 2011. The law authorizes the Food and Drug Administration (FDA) and the Secretary of Health and Human Services (HHS) to increase inspections of many domestic food facilities, enhance detection of food borne illness outbreaks, and order recalls of tainted food products. The law requires most food companies to write and implement new safety protocols to mitigate potential hazards. 25

26. President Barack Obama signs the FDA Food Safety Modernization Act into law Also, imported food products face increased scrutiny under the law, including denial of entry into the United States under certain circumstances. It is the most significant update of American food safety laws since the Federal Food, Drug, and Cosmetic Act in 1938. 26

27. R E F E R E NC E S D r . B .S. K u c hek a r , M r . A .M. Kha da t a r e, FOR E N S IC P HA R M AC Y 7 t h Edition August 2007 Published By- NIRALI PRAKASHAN ,PP-17.8 to 17.11, 17.25 to 17.28 Sachin C. Itkar, PHARMACEUTICAL MANAGEMENT 3 rd Edition May 2007 Published By- NIRALI PRAKASHAN ,PP-18.1 to 18.4 , 18.21 to 18.24 www.fda.gov www.wikepedia.com 27

28. Sagar Kishor Savale 28 04/2 8 /16