1. 1 04/28/16
Sagar Kishor Savale

2. Content
2
 Introduction
 History
 Responsibility of USFDA
 Organization
 Constitution
 FDAAdvisory committee
 Scope and Fundings
 Legal Authority of FDA
 Mission
 What USFDA regulates?
 What USFDA does not regulates?
 Recent Update
 References
04/28/16
Sagar Kishor Savale

3. FDA Logo
Agency overview
 Formed 1906
 Preceding agencies Food, Drug, and InsecticideAdministration (July 1927 to July 1930)
Bureau of Chemistry (July 1901 through July 1927)
Division of Chemistry, USDA (Established 1862)
 Jurisdiction Federal government of the United States
 Head quarters 10903 New HampshireAve, Silver Spring, MD 20903
 Employees 11,516
 Annual budget $2.3 billion
 Agency executive Margaret A. Hamburg, Commissioner of Food and Drugs
 Parent agency Department of Health and Human Services
 Website fda.gov
3 04/28/16
Sagar Kishor Savale

4. INTRODUCTION
4
• The Food and DrugAdministration (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.
04/28/16
Sagar Kishor Savale

5. HISTORY OF FDA
5
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.
04/28/16
Sagar Kishor Savale

6. 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.
04/28/16
Sagar Kishor Savale

7. RESPONSIBILITY OF FDA
7
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.
04/28/16
Sagar Kishor Savale

8. 8
 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 consists 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.
Margaret A. Hamburg, M.D.
Commissioner Of Food and Drugs
ORGANIZATION OF FDA
04/28/16
Sagar Kishor Savale

9. 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 forTobacco Products - which regulates cigarettes, cigarette tobacco,
roll-your-own tobacco, and smokeless tobacco.
 Center forVeterinary Medicine_
which regulates feed and drugs and devices
used in pets, farm animals, and other animals.
04/28/16
Sagar Kishor Savale

10. 10
National Center forToxicological 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 RegulatoryAffairs.
04/28/16
Sagar Kishor Savale

11. CONSTITUTION
11
• 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.
04/28/16
Sagar Kishor Savale

12. 12
• 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
04/28/16
Sagar Kishor Savale

13. FDA ADVISORY COMMITTEE
13
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.
04/28/16
Sagar Kishor Savale

14. How DOES AN INDIVIDUAL BECOME A
MEMBER OF AN FDA ADVISORY COMMITTEE?
14
 Professional 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.
04/28/16
Sagar Kishor Savale

15. SCOPE AND FUNDING
15
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.
04/28/16
Sagar Kishor Savale

16. LEGAL AUTHORITY Of FDA
16
 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
 1951 – Food, Drug, and Cosmetics Act Amendments 04/28/16
Sagar Kishor Savale

17. 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
04/28/16
Sagar Kishor Savale

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 04/28/16
Sagar Kishor Savale

19. MISSION OF FDA
19
• 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.
04/28/16
Sagar Kishor Savale

20. WHAT USFDA REGULATES?
20
• 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
04/28/16
Sagar Kishor Savale

21. 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
04/28/16
Sagar Kishor Savale

22. WHAT USFDA DOES NOT REGULATE ?
22
• 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
radiation)
• Drugs of Abuse - heroin and marijuana
• Health Insurance
• Meat and Poultry - except for game meats, such as venison, ostrich, an
snake
04/28/16
Sagar Kishor Savale

23. • Pesticides
• 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 04/28/16
Sagar Kishor Savale

24. RECENT UPDATE……
24
 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
medical devices. 04/28/16
Sagar Kishor Savale

25. FDA Food Safety Modernization Act
25
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.
04/28/16
Sagar Kishor Savale

26. 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.
04/28/16
Sagar Kishor Savale

27. REFERENCES
27
 Dr. B.S. Kuchekar, Mr. A.M. Khadatare, FORENSIC PHARMACY 7th
Edition August 2007 Published By- NIRALI PRAKASHAN ,PP-17.8
to 17.11, 17.25 to 17.28
 Sachin C. Itkar, PHARMACEUTICAL MANAGEMENT 3rd
Edition
May 2007 Published By- NIRALI PRAKASHAN ,PP-18.1 to 18.4 ,
18.21 to 18.24
 www.fda.gov
 www.wikepedia.com
04/28/16
Sagar Kishor Savale

28. 28 04/28/16
Sagar Kishor Savale