Pharmacology (Landmark Drug Legislation

jasmine's version from 2015-10-26 21:46


Question Answer
1906: Federal Pure Food and Drug Act Required only that drugs be free of adulterants; Stated nothing about safety or effectiveness; Very weak law
1938: Food, Drug, and Cosmetic ActThe first legislation to address drug safety; Required that all new drugs undergo testing for toxicity; Only those drugs judged safe would receive FDA approval
1962: Harris-Kefauver Amendments Sought to strengthen all aspects of drug regulation; Required that drugs be proved effective before marketing; First law to require that drugs be proved effective before marketing (Law was in response to the thalidomide tragedy [birth defects and fetal death] that occurred in Europe not United States)
1970: Controlled Substances Act Comprehensive Drug Abuse Prevention and Control Act; Set rules for the manufacture and distribution of drugs considered to have the potential for abuse; One provision defines 5 categories referred to as Schedules I, II, III, IV, V
1992: Permission of Accelerated Drug Approval Regulations permitting accelerated approval of drugs for AIDS and cancer. Under these guidelines, a drug could be approved for marketing prior to completion of Phase III trials, provided that rigorous follow-up studies in Phase IV trials were performed
2 Rationals for 1992 Permission of Accelerated Drug Approval 1) Medications are needed, even if their benefits may be marginal; and 2) The unknown risks associated with early approval are balanced by the need for more effective drugs
2 Drawbacks for 1992 Permission of Accelerated Drug Approval 1) Manufacturers often fail to conduct or complete the required follow-up studies; and 2) If the follow-up studies, which are more rigorous than the original, fail to confirm a clinical benefit, the guidelines have no clear mechanism for removing the drug from the market
1992: Prescription Drug User Fee Act Drug sponsors pay the FDA fees (about 500,000 per drug) that are used to fund additional reviewers, and in return, the FDA must adhere to strict review timetables; Was in response to complaints that the FDA takes too long to review applications for new drugs, and new drugs now reach market much sooner
1997: Food & Drug Administration Modernization Act An extension of the Prescription Drug User Fee Act that called for widespread changes in FDA regulations
Four particular provisions of particular interest for health professionals from 1997 Food & Drug Administration Modernization Act 1) Fast-track system created for AIDS drugs and cancer drugs now includes drugs for other serious and life-threatening illnesses; 2) Manufacturers who plan to stop making a drug must inform patients at least 6 months in advance; 3) A clinical trial database will be established for drugs directed at serious or life-threatening illnesses with the data allowing clinicians and patients to make informed decisions about using experimental drugs; and 4) Drug companies can now give prescribers journal articles and certain other information regarding "off-label" uses of drugs (an "off-label" use is a use that has not been evaluated by the FDA); Prior to new act, clinicians were allowed to prescribed a drug for an off-label use, yet manufacturer was not allowed to promote the drug for the use
2002: Best Pharmaceuticals for Children ActDesigned to promote much-needed research on drug efficacy and safety in children; Offers a 6-month patent extension to manufacturers who evaluate a drug already on the market for its safety, efficacy, and dosage in children
2003: Pediatric Research Equity Act Designed to promote much-needed research on drug efficacy and safety in children; Gives the FDA the power, for the first time, to require drug companies to conduct pediatric clinical trials on new medications that might be used by children
2007: FDA Amendments Act The most important legislation on drug safety since the Harris-Kefauver Amendments of 1962; FDA has the legal authority to require post-marketing safety studies, to order changes in a drug's label to include new safety information, and to restrict distribution of a drug based on safety concerns; In addition, the FDA is required to establish an active post-marketing risk surveillance system, mandated to include 25 million patients by July 2010, and 100 million by July 2012
2009: Family Smoking Prevention and Tobacco Control Act Allows the FDA to regulate cigarettes, the single most dangerous product available to United States consumers; FDA can strengthen advertising restrictions, including prohibition on marketing to youth, require revised and more prominent warning labels, require disclosure of all ingredients in tobacco products and restrict harmful additives, and monitor nicotine yields and mandate gradual reduction of nicotine to non-addictive levels