FSC-421

Section 201 (G)
 (A) Aricles recognized in Official
Pharmacoepia
 (B) Articles intended for use in cure , mitigation , treatment or prevention of diseases in man
 (C) Articles intended to affect structure and function of body of man or animals

The History of Drug Regulation in the United States

The Early Days
 No Regulation
– Early 1900's anything available
– Any Claim could be made
– Ingredient declaration not required
– Opium, Cocaine, Heroin freely distributed and used in medicines

History of Drug Regulation
 1820 -- Physicians meet in D.C. to establish U.S. Pharmacopeia , first compendium of drugs
 1848 -The Drug Importation Act passed by Congress requires U.S.
Customs Service inspection to stop the entry of adulterated drugs from overseas

History of Drug Regulation
 1862 -President Lincoln creates Bureau of
Chemistry within USDA and appoints Charles
Wetherill as Chief Chemist
 1883 -Harvey Wiley becomes Chief Chemist in charge of adulteration studies and campaigns for
"Pure Food and Drugs Act"
 1902 -Biologics Control Act passed to ensure purity and safety of vaccines, serums etc. used to treat humans

History of Drug Regulation
 1901 - Contaminated Smallpox
Vaccines (New Jersey)
 1902 - Contaminated diptheria vaccine (St. Louis)
 1902 - Coca-Cola / cocaine
 Drug scares
– "Cocaine crazed Negroes"
– "Reefer Madness"

History of Drug Regulation
 New Laws
– 1906 -Pure Food and Drugs Act and
Meat Inspection Act signed into law by
President Roosevelt on same day
 Problem:
– 1911 -U.S. v Johnson FDCA does not prohibit "false theraputic claims", only false and misleading statements about ingredients

History of Drug Regulation
 Response:
– 1912 -Shirley Amendments enaacted to overcome U.S. v Johnson
– Legislative action required after Sup. Ct. ruling to make a change
– Prohited false theraputic claims intended to defraud

History of Drug Regulation
 1914 -- THE HARRISON NARCOTIC
ACT
– required prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.

History of Drug Regulation
 1927 -- Bureau of Chemistry becomes Food,
Drug and Insecticide Admistration
 1930 -- FDIA renamed FDA
 1938 -Federal Food Drug and Cosmetics
Act passed
– Premarket approval of new drugs

History of Drug Regulation
 1938 -Wheeler-Lea Act requires FTC to oversee advertising of FDA products (except prescription drugs)
 1943 -U.S. Dotterwich
 1945 -Penicillin Amendments requires testing of safety of all penicillin products

History of Drug Regulation
 1950 -- Albert Foods v. U.S.
- directions on label must include purpose for which drug is offered
 1951 -Durham-Humphrey Amendment defines safe OTC vs. Prescription drugs
 1954 -Radiological examination of foods after radioactive tuna suspected from Hbombs

History of Drug Regulation
 1958 -Food Additives Amendment
 Explosive growth in medical device technology
 1972 -- Labeling and safety of OTC drugs reviewed
 1976 Medical Devices Amendment
– Premarket approval of devices

Controlled Substances Act of 1970
 Result of Nixon's war on LSD
– Hippies, Timothy Leary, and Vietnam War
 Created Schedules
– Schedule 1 = no medical use
• Heroin, Marijuana, LSD
– Schedule 2
• Cocaine

Controlled Substances Act of 1970
 Simply move drug to higher schedule
 No need for congressional acts
– Harrison Act
 5 - 40 years imprisonment / 2 million fine

History of Drug Regulation
 1990 -- Safe Medical Devices Act
 1994 -Dietary Supplement Health and
Education Act
 1997 -FDA Modernization Act
– Accelerated review for new devices
– Regulation of approved and unapproved uses of drugs
– Regulation of Health Claims

Current Drug Regulation
 FDCA requires "pre-market approval" of all new drugs
– Manufacturer must demonstrate
"safety and efficacy"
• Animal testing studies
– Post-market surveillence
– GMP's

Current Drug Regulation
 FDA has jurisdiction over:
– Drugs
– Biologics
– Medical Devices
– Cosmetics

Drugs Approval Process:
 Studies by manufacturer to prove safety and efficacy
– Animal and Clinical tests
– Investigational Exemption
• Can sell limited quantities for clinical testing
 New Drug Application (NDA)
 Postmarket surveillance

Tobacco Regulation
 FDA issued proposed regulations
(ANPRM) in August 1996, finding that tobacco products were a combination of a drug and a drug delivery device
 Nicotine in tobacco is a drug and sustains addiction and that cigarette makers intend its effects.

Tobacco Regulation
 Nicotine’s widely recognized properties were foreseeable to any manufacturer (Negligence std)
 Had documents suggesting that cigarette companies had long known that smokers use tobacco products to get the effects of nicotine

Tobacco Regulation
 Major tobacco companies challenged the rules in court
 Lower court judge upheld the FDA’s authority but said it could not limit advertising
 4th Circuit Court of Appeals ruled 2-1 that “FDA lacks jurisdiction to regulate tobacco products"

FDA Agruments:
 The law allows regulation of any drug
“intended” to affect the functioning of the body
 Cigarette manufacturers engineer their products to deliver active doses of nicotine
 Cigarette makers manipulate the content of cigarettes to promote nicotine’s effects .

Manufacturer's Argument:
 Never suggested that people should smoke to get nicotine
 Companies have no duty over uses of their products that they do not promote
 FDA cannot regulate unpromoted uses of lawfully sold products

Manufacturer Arguments:
 If FDA were to undertake regulation, it would have no choice but to ban cigarettes , because it cannot allow an unsafe product to remain on the market
 Not what Congress intended under the legion of laws that regulate the tobacco industry

Amicus Briefs:
 FDA
– Public interest in protecting 3,000 children a day from becoming addicted to nicotine far outweighs the industry’s interest in avoiding regulations
 Industry
– Congress should decide whether tobacco products should be regulated by the FDA

FDA vs. Brown & Williamson
 March 21, 2000
 Held:
Federal government lacks authority to regulate tobacco as an addictive drug because it contains nicotine
 FDA does not have jurisdiction over tobacco products (Butt Kicking)

FDA vs. Brown & Williamson
 FDA has authority to regulate only products that are safe and effective , it cannot have authority over tobacco an inherently dangerous product
 Clear that Congress never intended the FDA to have such authority

Summary
 1906 Pure Food and Drug Act enacted as "drug" law as much as a "food" law
 Drug defined as articles intended to affect structure and function of body of man or animals
 New drugs require premarket approval
 Manufacturer must prove safety and efficacy
 Currently, FDA has no jurisdiction over tobacco
 Controlled substances regulated by schedules