Eleven physicians meet in Washington, D.C., to establish the U.S. Pharmacopeia, the first compendium of standard drugs for the United States. 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 (On-line information at www.fda.gov\oc\history) 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. Publication of Lewis Caleb Beck’s Adulteration of Various Substances Used in Medicine and the Arts, helps document problems in the drug supply. Rising Popularity of Patent Medicines or The Great American Fraud and the Pure Food The Sulfanilamide Disaster and the Federal Food, “Nostrums” in the 19th Century and Drugs Act of 1906 Drug, and Cosmetic Act of 1938 Drug Importation Act passed by Congress requires U.S. Customs Service inspection to stop entry of adulterated drugs from overseas. Throughout the 1800’s, in an era of limited In the early 1900’s, while famed Between 1906 and 1938, legal physician tools for treating illness that had muckraking journalist Upton proceedings over many problems with been scrutinized and supported by Sinclair’s publications detailed dangerous drugs demonstrated that empirical evidence and the scientific the horrific conditions of the the Pure Food and Drugs Act did not method, an increasingly urbane population meat-packing industry, some of go far enough to protect public safety. in the United States developed an appetite his colleagues exposed the false In 1937, Massengill distributed an Lyman F. Kebler, M.D., Ph.C., assumes duties for medical elixirs. Marketed through claims, harmful ingredients, and Elixir Sulfanilamide indicated for as Director of the Drug Laboratory, Bureau of Chemistry. exoticism, mystery, and grandiose claims of market manipulation of nostrums “all conditions in which the hemolytic streptococci efficacy, these medicines claimed to cure and their producers. The most appear.” It contained diethylene glycol, a chemical everything from cancer, venereal disease, famous of these investigations was analogue of antifreeze, leading to the documented female troubles, stomach aches, and published in Collier’s magazine by Samuel deaths of 107 people, including many children. This epilepsy. One product sold widely in the late Hopkins Adams in a series entitled “The Great disaster became the urgent impetus for the passing 1800’s and early 20th century, William Radam’s American Fraud,” concluding in February, 1906, of the Federal Food, Drug, and Cosmetic Act. Microbe Killer, boldly declared on the label the same month Sinclair’s The Jungle was Among the Act’s provisions were notably that all Samuel Hopkins Adams’ ten-part exposé of the patent medicine industry, “The Great American “Cures all diseases,” while Dr. Sibley advertised published. Four months later, the first Federal drugs be tested for safety prior to Fraud,” begins in Collier’s. The American Medical Association, through its that his Solar Tincture was even able Pure Food and Drug Act was published, marketing, and the results submitted Council on Pharmacy and Chemistry, initiates a voluntary program of drug approval that to “restore life in the event of sudden prohibiting interstate commerce of adulterated and to the FDA in a new drug application would last until 1955. To earn the right to advertise in AMA and related journals, companies submitted evidence, for review by death.” In fact, these products often misbranded food and drugs. Though this led many (NDA). It additionally authorized the Council and outside experts, to support their therapeutic claims for drugs. simply relied upon opiates, cocaine, patent medicines to remove narcotics instead of factory inspections, and required the or alcohol to make imbibers feel label them, it was less successful in corralling establishment of safe tolerances for better or “cured”; however, in many exaggerated claims or preventing many dangerous unavoidable poisonous The original Food and Drugs Act is passed by cases, they contained toxic substances from substances. Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated ingredients such as acetanilide reaching foods and drugs. The Meat Inspection Act is passed the same day. Shocking disclosures of or cresyl phosphate consumers. Furthermore, FDA promulgates the insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and (an organophosphate causing policy in August that sulfanilamide dangerous patent medicines were the major problems leading to the enactment of these nerve paralysis). and selected other dangerous drugs laws. must be administered under the direction of a qualified expert, thus launching the requirement for In U.S. v. Johnson, the Supreme Court rules that the 1906 Food and Drugs Act does not prescription only (non-narcotic) prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug. drugs. Congress enacts the Sherley Amendment The Harrison Narcotic Act imposes upper FDA recommends a complete revision of the Elixir Sulfanilamide, containing the poisonous The Federal Food, Drug, and Cosmetic Act of Insulin Amendment requires FDA to test and A nationwide investigation by FDA reveals HEW Secretary Olveta Culp Hobby appoints a Thalidomide, a new sleeping pill, is found to have caused birth defects FDA Bureau of Drug Abuse Control and the Treasury to overcome the ruling in U.S. v. Johnson. limits on the amount of opium, opium-derived obsolete 1906 Food and Drugs Act. The first solvent diethylene glycol, kills 107 persons, 1938 is passed by Congress, containing certify purity and potency of this life-saving that chloramphenicol, a broad-spectrum committee of 14 citizens to study the adequacy in thousands of babies born in western Europe. News reports on the role Department’s Bureau of Narcotics are transferred to the It prohibits labeling medicines with false products, and cocaine allowed in products bill is introduced into the Senate, launching a many of whom are children, dramatizing the significant new provisions requiring drugs to drug for diabetes. antibiotic, has caused nearly 180 cases of often of FDA’s facilities and programs. The of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the Department of Justice to form the Bureau of Narcotics therapeutic claims intended to defraud the available to the public; requires prescriptions five-year legislative battle. need to establish drug safety before marketing be proven safe before marketing. fatal blood diseases. Two years later FDA committee recommends a substantial U.S. market, arouse public support for stronger drug regulation. and Dangerous Drugs (BNDD), consolidating efforts to purchaser, a standard difficult to prove. for products exceeding the allowable limit of and to enact the pending food and drug law. Nearly 300 deaths and injuries result from would engage the American Society of expansion of FDA staff and facilities, a new police traffic in abused drugs. A reorganization of BNDD narcotics; and mandates increased FDA assembles a graphic display of Under the Wheeler-Lea Act, the Federal Trade distribution of sulfathiazole tablets tainted with Hospital Pharmacists, the American headquarters building, and more use of Kefauver-Harris Drug Amendments are passed to ensure drug efficacy in 1973 formed the Drug Enforcement Administration. record-keeping for physicians and pharmacists shortcomings in pharmaceutical and other Commission is charged to oversee advertising the sedative, phenobarbital. The incident Association of Medical Record Librarians, and educational and informational programs. and greater drug safety. For the first time, drug manufacturers are that dispense narcotics. A separate law dealing regulation under the 1906 act, dubbed by one associated with products, including prompts FDA to revise manufacturing and later the American Medical Association in a required to prove to FDA the effectiveness of their products before FDA forms the Drug Efficacy Study Implementation with marijuana would be enacted in 1937. reporter as the Chamber of Horrors, exhibited pharmaceuticals, otherwise regulated by FDA. quality controls drastically, the beginning of voluntary program of drug reaction reporting. marketing them. In addition, FDA is given closer control over (DESI) to incorporate the recommendations of a National nationwide to help draw support for a new law. what would later be called good manufacturing investigational drug studies, FDA inspectors are granted access to Academy of Sciences investigation of effectiveness of practices (GMPs). additional company records, and manufacturers must demonstrate the drugs marketed between 1938 and 1962. efficacy of products approved prior to 1962. In Upjohn v. Finch, the Court of Appeals Over-the-Counter Drug Review initiated to Tamper-resistant packaging regulations issued Orphan Drug Act passed, enabling FDA to Drug Price