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food and drug administration

Lab Presentation

By
Anupam Kr.Choubey
M.Pharm 1st sem

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Flow of presentation
v v v v v v v

Introduction Responsibilities History Organization Legal Authorities Powers Functions

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introduction

An agency of the United State Department of Health and Human Services. Consists of six product centers, one research center, and two offices. Headquarters at New Hampshire Ave,Silver Spring , Maryland, USA. Led by the Commissioner of food and drugs, appointed by the President with the advice and consent of the Senate.

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responsibilities
Protecting and promoting the 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,

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history
Vaccine Act of 1813. First Federal Law Dealing with Consumer Protection and Drugs Preceding agencies

Division of Chemistry, USDA (Established 1862) Under Harvey Washington Wiley, appointed chief chemist in 1883, Bureau of Chemistry, USDA (July 1901 through July 1927) Food, Drug, and Insecticide

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Contd
Regulation of human drugs and medical devices after 1938
v

Early FD&C Act amendments: 1938-1958

1951 Durham-Humphrey Amendment Insulin Amendment and Penicillin Amendment

Expansion of premarket approval process: 1959-1985

The 1962 Kefauver-Harris Amendment

1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the

organization

fda
Office of the Commissio ner Office of Regulat ory Affairs

Center for Food Safety & Applied

Center for Drug Evaluati on &

Center for Biologics Evaluatio n& Research

Center for Devices & Radiologi cal

Center for Veterin ary Medici ne

National Center for Toxicolog ical Research

Center for Tobacc o

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Legal authority

Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act and are codified in Title 21, Chapter 9 of the United States Code. Public Health Service Act, Parts of the Controlled Substances Act The Federal Anti-Tampering Act

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Contd
Important enabling legislation for the FDA includes:

1902 Biologics Control Act 1906 Pure Food and Drug Act 1938 Federal Food, Drug, and Cosmetic Act 1951 1951 Food, Drug, and Cosmetics Act Amendments 1962 1962 Food, Drug, and Cosmetics Act Amendments

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Contd

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 2003 Animal Drug User Fee Act 2007 Food and Drug Administration Amendments Act 2009 Family Smoking Prevention and Tobacco

Federal Food, Drug, 4/17/12 and Cosmetic Act (FD&C Act)

q

The Federal Food, Drug, and Cosmetic Act was passed in 1938 after a legally marketed toxic elixir killing 107 people, including many children. The law authorized the FDA to
demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.

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Contd
v

FD&C Act Chapter I & II Short Title and Definitions

FD&C Act Chapter III: Prohibited Acts and Penalties

v v v v

FD&C Act Chapter IV : Food FD&C Act Chapter V : Drugs and Devices FD&C Act Chapter VI: Cosmetics FD&C Act Chapter VII : General Authority

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Powers
Administrative:

Establishment inspections Warning letters Recalls Publicity Detentions Import and export controls Product approval or license withdrawals and suspensions Civil penalty proceedings

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Contd
Judicial:

Seizures Injunctions Misdemeanor prosecution Felony prosecution

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Prohibited Acts

The Federal Food, Drug, and Cosmetic Act (FDCA) enumerates 25 separate categories of prohibited acts Both specific acts and the causing thereof are prohibited

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Contd

The principal statutory offenses involve:

Adulteration

Product is (or may be) unsafe, ineffective or unsanitary; non-compliance with good manufacturing practices

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Contd
Others:

Failure to maintain records or comply with reporting requirements Failure to comply with investigational new drug application (IND) or investigational device exemption (IDE) requirements Failure to submit a 510(k) notification when required; refusal to permit inspection Giving a false guarantee

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Inspection Authority
FDA conducts inspections for many reasons:

Routine

Good Manufacturing Practice

(GMP) audits
A A A A

directed inspection for a specific reason reinspection after a Warning Letter recall effectiveness check preapproval inspection

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Contd

Authority to inspect establishments given in Section 704 of the FDCA FDA has jurisdiction to inspect any establishment where food, drugs, devices, biologics, or cosmetics are manufactured, processed, packed or held before or after introduction into interstate commerce FDA will issue a Form FD-482, a Notice of Inspection, and show credentials Inspections must occur at reasonable times, within reasonable limits, and in a reasonable manner Establishments usually subject to inspection

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DRUG REGULATION
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Basic Mission
Safety Efficacy

Drugs Medical Devices Adulteration Misbranding

Truthful Labeling

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Getting a Drug Approved by fda

Isolate or Synthesize the Agent Do Animal or in Vitro Studies to Determine Activity Apply for an Investigational New Drug (IND) Permit Go for Clinical Trials

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Clinical Trials
Phase I What are the side effects? Is it safe enough to test?

Phas Phase III e II

Application

Is it better than placebo? Drug Apply For New

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Generic drugs

Chemical equivalents of name-brand whose patents have expired

drugs

For approval FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an "ANDA" (Abbreviated New Drug Application).

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Over-the-counter drugs

Over-the-counter (OTC) drugs are drugs and combinations that do not require a doctor's prescription Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without a medical practitioner's supervision The FDA has a list of approximately 800 approved ingredients that are combined in various ways to create more than 100,000 OTC

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Criticism
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The FDA has been criticized for as being too tough on industry. According to an analysis published on the website of the libertarian Mercatus Center as well as published statements by economists, medical practitioners, and concerned consumers, many feel the FDA oversteps its regulatory powers and undermines small business and small farms in favor of large corporations.

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