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A Brief History of Early Drug Regulation in the United States

The U.S. Food and Drug Administration is the oldest federal agency dedicated to consumer protection, originating as a single chemist appointed to the U.S. Department of Agriculture in 1862. FDA in 2006 employed more than 10,000 toxicologists, chemists, pharmacologists, physicians, microbiologists, pharmacists, veterinarians, lawyers, and others. This poster, excerpted from materials produced by the FDA's History Office highlights the fascinating early origins of the regulation of medicines and accompanies several objects generously loaned by the University of Arizona's Museum of Pharmacy.

Rising Popularity of Patent Medicines or "Nostrums" in the 19th Century

Throughout the 1800's, in an era of limited physician tools for treating illness that had been scrutinized and supported by empirical evidence and the scientific method, an increasingly urbane population in the United States developed an appetite for medical elixirs. Marketed through exoticism, mystery, and grandiose claims of efficacy, these medicines claimed to cure everything from cancer, venereal disease, female troubles, stomach aches, and epilepsy. One product sold widely in the late 1800's and early 20th century, William Radam's Microbe Killer, boldly declared on the label "Cures all diseases," while Dr. Sibley advertised that his Solar Tincture was even able to "restore life in the event of sudden death." In fact, these products often simply relied upon opiates, cocaine, or alcohol to make imbibers feel better or "cured;" however, in many cases, they contained toxic ingredients such as acetanilide or cresyl phosphate (an organophosphate causing nerve paralysis).


The Great American Fraud and the Pure Food and Drugs Act of 1906

In the early 1900's, while famed muckraking journalist Upton Sinclair's publications detailed the horrific conditions of the meat-packing industry, some of his colleagues exposed the false claims, harmful ingredients, and market manipulation of nostrums and their producers. The most famous of these investigations was published in Collier's magazine by Samuel Hopkins Adams in a series entitled "The Great American Fraud," concluding in February, 1906, the same month Sinclair's The Jungle was published. Four months later, the first Federal Pure Food and Drug Act was published, prohibiting interstate commerce of adulterated and misbranded food and drugs.

Though this led many patent medicines to remove narcotics instead of label them, it was less successful in corralling exaggerated claims or preventing many dangerous substances from reaching consumers.

The Sulfanilamide Disaster and The Federal Food, Drug, and Cosmetic Act of 1938

Between 1906 and 1938, legal proceedings over many problems with dangerous drugs demonstrated that the Pure Food and Drugs Act did not go far enough to protect public safety. In 1937, Massengill distributed an Elixir Sulfanilamide indicated for "all conditions in which the hemolytic streptococci appear." It contained diethylene glycol, a chemical analogue of antifreeze, leading to the documented deaths of 107 people, including many children. This disaster became the urgent impetus for the passing of the Federal Food, Drug, and Cosmetic Act. Among the Act's provisions were notably that all drugs be tested for safety prior to marketing, and the results submitted to the FDA in a new drug application (NDA).

It additionally authorized factory inspections, and required the establishment of safe tolerances for unavoidable poisonous substances.

Furthermore, FDA promulgates the policy in August that sulfanilamide and selected other dangerous drugs must be administered under the direction of a qualified expert, thus launching the requirement for prescription only (non-narcotic) drugs.

Timeline:

1820 Eleven physicians meet in Washington, D.C., to establish the U.S. Pharmacopeia, the first compendium of standard drugs for the United States.
1846 Publication of Lewis Caleb Beck's Adulteration of Various Substances Used in Medicine and the Arts, helps document problems in the drug supply.
1848 Drug Importation Act passed by Congress requires U.S. Customs Service inspection to stop entry of adulterated drugs from overseas.
1903 Lyman F. Kebler, M. D., Ph. C., assumes duties as Director of the Drug Laboratory, Bureau of Chemistry.
1905 Samuel Hopkins Adams' ten-part exposť of the patent medicine industry, "The Great American Fraud," begins in Collier's.

The American Medical Association, through its Council on Pharmacy and Chemistry, initiates a voluntary program of drug approval that would last until 1955. To earn the right to advertise in AMA and related journals, companies submitted evidence, for review by the Council and outside experts, to support their therapeutic claims for drugs.
1906 The original Food and Drugs Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods and drugs. The Meat Inspection Act is passed the same day. Shocking disclosures of insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines were the major problems leading to the enactment of these laws.
1911 In U.S. v. Johnson, the Supreme Court rules that the 1906 Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug.
1912 Congress enacts the Sherley Amendment to overcome the ruling in U.S. v. Johnson. It prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove.
1914 The Harrison Narcotic Act imposes upper limits on the amount of opium, opium-derived products, and cocaine allowed in products available to the public; requires prescriptions for products exceeding the allowable limit of narcotics; and mandates increased record-keeping for physicians and pharmacists that dispense narcotics. A separate law dealing with marijuana would be enacted in 1937.
1933 FDA recommends a complete revision of the obsolete 1906 Food and Drugs Act. The first bill is introduced into the Senate, launching a five-year legislative battle.

FDA assembles a graphic display of shortcomings in pharmaceutical and other regulation under the 1906 act, dubbed by one reporter as the Chamber of Horrors, exhibited nationwide to help draw support for a new law.>
1937 Elixir Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.
1938 The Federal Food, Drug, and Cosmetic Act of 1938 is passed by Congress, containing significant new provisions requiring drugs to be proven safe before marketing.

Under the Wheeler-Lea Act, the Federal Trade Commission is charged to oversee advertising associated with products, including pharmaceuticals, otherwise regulated by FDA.
1941 Insulin Amendment requires FDA to test and certify purity and potency of this life-saving drug for diabetes.

Nearly 300 deaths and injuries result from distribution of sulfathiazole tablets tainted with the sedative, phenobarbital. The incident prompts FDA to revise manufacturing and quality controls drastically, the beginning of what would later be called good manufacturing practices (GMPs).
1952 A nationwide investigation by FDA reveals that chloramphenicol, a broad-spectrum antibiotic, has caused nearly 180 cases of often fatal blood diseases. Two years later FDA would engage the American Society of Hospital Pharmacists, the American Association of Medical Record Librarians, and later the American Medical Association in a voluntary program of drug reaction reporting.
1955 HEW Secretary Olveta Culp Hobby appoints a committee of 14 citizens to study the adequacy of FDA's facilities and programs. The committee recommends a substantial expansion of FDA staff and facilities, a new headquarters building, and more use of educational and informational programs.
1962 Thalidomide, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.

Kefauver-Harris Drug Amendments are passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them. In addition, FDA is given closer control over investigational drug studies, FDA inspectors are granted access to additional company records, and manufacturers must demonstrate the efficacy of products approved prior to 1962.
1968 FDA Bureau of Drug Abuse Control and the Treasury Department's Bureau of Narcotics are transferred to the Department of Justice to form the Bureau of Narcotics and Dangerous Drugs (BNDD), consolidating efforts to police traffic in abused drugs. A reorganization of BNDD in 1973 formed the Drug Enforcement Administration.

FDA forms the Drug Efficacy Study Implementation (DESI) to incorporate the recommendations of a National Academy of Sciences investigation of effectiveness of drugs marketed between 1938 and 1962.
1970 In Upjohn v. Finch, the Court of Appeals upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy.

FDA requires the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits.
1972 Over-the-Counter Drug Review initiated to enhance the safety, effectiveness, and appropriate labeling of drugs sold without prescription.
1982 Tamper-resistant packaging regulations issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules. The Federal Anti-Tampering Act passed in 1983 makes it a crime to tamper with packaged consumer products.
1983 Orphan Drug Act passed, enabling FDA to promote research and marketing of drugs needed for treating rare diseases.
1984 Drug Price Competition and Patent Term Restoration expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective. At the same time, the brand-name companies can apply for up to five years additional patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process.
1987 FDA revises investigational drug regulations to expand access to experimental drugs for patients with serious diseases with no alternative therapies.
1988 The Prescription Drug Marketing Act bans the diversion of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, subpotent, and counterfeit drugs to the public. The new law requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.
1991 FDA publishes regulations to accelerate reviews of drugs for life-threatening diseases.
1995 FDA declares cigarettes to be "drug delivery devices." Restrictions are proposed on marketing and sales to reduce smoking by young people.
1997 Food and Drug Administration Modernization Act reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, advertising unapproved uses of approved drugs and devices, health claims for foods in agreement with published data by a reputable public health source, and development of good guidance practices for agency decision-making.

U.S. Food and Drug Administration Centennial at CDER Web site.




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