The Regulation of The Regulation of Human DrugsHuman Drugs

FSC-421

What is a Drug?What is a Drug?

Section 201 (G)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 History of Drug Regulation in the United Statesthe United States

The Early DaysThe 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 RegulationHistory 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 RegulationHistory 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 RegulationHistory 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 RegulationHistory 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 RegulationHistory 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 RegulationHistory 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 RegulationHistory 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 RegulationHistory of Drug Regulation

1938 -- Wheeler-Lea Act requires FTC to oversee advertising of FDA products (except prescription drugs)

1943 -- U.S. Dotterwich1945 -- Penicillin Amendments

requires testing of safety of all penicillin products

History of Drug RegulationHistory 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 H-bombs

History of Drug RegulationHistory of Drug Regulation

1958 -- Food Additives Amendment Explosive growth in medical device

technology1972 -- Labeling and safety of OTC

drugs reviewed 1976 Medical Devices Amendment– Premarket approval of devices

Controlled Substances Act of 1970Controlled 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 1970Controlled 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 RegulationHistory of Drug Regulation

1990 -- Safe Medical Devices Act1994 -- 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 RegulationCurrent 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 RegulationCurrent Drug Regulation

FDA has jurisdiction over:–Drugs

–Biologics

–Medical Devices

–Cosmetics

How are Drugs Approved?How are Drugs Approved?

Drugs Approval Process: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

The Regulation of The Regulation of TobaccoTobacco

Tobacco RegulationTobacco 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 RegulationTobacco 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 RegulationTobacco 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: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: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: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: 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 & WilliamsonFDA vs. Brown & Williamson

March 21, 2000Held:

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 & WilliamsonFDA 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

SummarySummary

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