Drug Policy (Laws & Regulations)

Drug Policy Two Classes of Drug Laws • regulation of "legal" drugs for: Pharmaceutical Pharmacists Physicians Others who manufacture and dispose them Criminalization of certain drugs for their: use Possession Sales Beginnings of Regulation • issues leading to legislation - widespread legal distribution of patent medicines - Concerns about drug abuse being associated with mortality and race • three pieces of legislation inform current drug laws - 1906 Pure Food and Drugs Act 1914 Harrison Act 18th Amendment, Alcohol Prohibition in 1918 Issues Leading to Legislation • fraud in patent medicines sold directly to the public False theraputic claims habit forming drug content • Opium opium Smoking was brought to the United States by Chinese workers the United States signed. in 1833 its first treaty to control international opium trade -laws passed against the importation, manufacture, and use of opium were: viewed as racist in response to an 1887 agreement with China • Cocaine was present in products such as: patent medicines and tonics Coca-cola viewed as a Cause of increasing crime perpetrated by "lower Class" blacks in the South adopted a racist approach 1900 Pure Food and Drugs Act * prohibited interstate commerce in misbranded and adulterated drugs misbranding referred to only to labeling and not advertising Specifically referred to alconol, morphine, opium, cocaine, heroin, Cannabis indica, and other agents protected people from unscrupulous merchants, not from themselves • provided the rootstock on which all modern laws regulating pharmaceuticals have been grafted Harrison Act of 1914 • required those who "produce, import, manufacture, Compound, deal in, dispense, or give away" Certain drugs to register and pay a special tax initially controlled opium and cocaine • later expanded to include other federal Controlled-Substance regulations Two Types of Regulation • The Pure Food and Drugs Act, 1906 -administered within the United States Department of Agriculture goal: to ensure that drugs are pure and honestly labeled Harrison Act, 1914 administered by the United States Treasury Department goal: taxation of drugs to restrict commerce in opiods and cocaine to authorized Physicians, pharmacists, and legitimate manufacturers Regulation of Pharmaceuticals •purity -1906 Pure Food and Drugs Act product contents must be accurately listed on the label from its beginning, Food and Drug Administration or FDA has encouraged voluntary Cooperation rather than forced compliance -1912 Sherley Amendment outlawed "false and fraudulent" theraputic claims on labels •Safety -1906 Pure Food and Drug Act had no legal requirement that medicines be safe 1938 Food, Drug and Cosmetic Act required premarket testing of new drugs for toxicity *FDM became a gatekeeper Companies were required to Submit a New Drug Application or NDA reduced the likelihood of new drugs being introduced by small companies run by untrained people directions that must be included adequate instructions for consumer Statement that the drug can be used only upon a physician's prescription effectiveness - 1938 Food, Drug, and Cosmetic Act no legal requirement that medications be effective 1962 kefauver-Harris Amendments. required approval for human testing before Clinical trials begin advertising for prescription drugs must include information about adverse reactions every new drug must be demonstrated to be effective for the illnesses mentioned on the label Process for Introducing a New Drug • preclinical research and development "Company Submits a "Notice of Claimed Investigational Exemption for a New Drug" or - IND to the FDA - Company also Submits all preclinical investigations, including effects of drug on animals Clinical research and development phase one: how the drug is absorbed and excreted who is tested: 20 to 80 healthy volunteers who are given low doses phase two: initial effectiveness testing who is tested: a few hundred patients who could benefit phase three: broader effectiveness testing who is tested: typically 1,000 to 5,000 patients