The Regulation of Human Drugs FSC-421

What is a Drug?

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 Physicians meet in D.C. to establish U.S. Pharmacopeia, first compendium of drugs 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 President Lincoln creates Bureau of Chemistry within USDA and appoints Charles Wetherill as Chief Chemist Harvey Wiley becomes Chief Chemist in charge of adulteration studies and campaigns for "Pure Food and Drugs Act" Biologics Control Act passed to ensure purity and safety of vaccines, serums etc. used to treat humans

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

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

History of Drug Regulation Response: – 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 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 Bureau of Chemistry becomes Food, Drug and Insecticide Admistration FDIA renamed FDA Federal Food Drug and Cosmetics Act passed –Premarket approval of new drugs

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

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

History of Drug Regulation Food Additives Amendment Explosive growth in medical device technology 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 years imprisonment / 2 million fine

History of Drug Regulation Safe Medical Devices Act Dietary Supplement Health and Education Act 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

How are Drugs Approved?

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 Tobacco

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