Download Pharmacopolitics: Drug Regulation in the United States and by Arthur A. Daemmrich PDF

By Arthur A. Daemmrich

Advocates of swift entry to drugs and critics terrified of insufficient trying out either argue that globalization will supersede nationwide scientific practices and lead to the straightforward move of prescribed drugs all over the world. In Pharmacopolitics, Arthur Daemmrich demanding situations their assumptions by way of evaluating drug legislation, medical trials, and platforms for tracking adversarial reactions within the usa and Germany, nations with equally complex platforms for scientific study, trying out, and sufferer care. Daemmrich proposes that divergent "therapeutic cultures--the interrelationships between governments, sufferers, the clinical occupation, and the pharmaceutical industry--underlie nationwide alterations and clarify diversifications in pharmaceutical markets and treatment.

Daemmrich includes the United States-Germany comparability from 1950 to the current via case reports of Terramycin (an antibiotic), thalidomide (a sedative), propranolol (a center medication), interleukin-2 (a melanoma therapy), and indinavir (an AIDS drug). He issues to various political structures of "the sufferer" within the usa and Germany to elucidate vital modifications in govt rules and within the distribution of strength between key social actors. Daemmrich advises that foreign regulatory harmonization and globalization in medication needs to hold flexibility for social and political version among nations, while they in attaining technical standardization.

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Extra info for Pharmacopolitics: Drug Regulation in the United States and Germany (Studies in Social Medicine)

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Pharmaceutical firms also turned to developing medicines for long-term conditions ranging from diabetes to depression. ∞∂ Prices were remarkably uniform among competing brands of antibiotics and other medications in the 1950s. Noting concerns about inflation across the country, the populist Democratic senator from Tennessee, Estes Kefauver, launched an investigation into a number of industry sectors starting in 1957. His primary focus was on ‘‘administered prices,’’ a form of price-fixing by industry leaders first described by the New Deal economist Gardiner Means.

Claims regarding public health and patients’ access to drugs attracted congressional attention, and both Wardell and Lasagna were cited frequently in proposals to reform the FDA. ≥≤ The primary policy lesson FDA o≈cials drew from the thalidomide case was to emphasize premarket testing 30 F D R U G L A W S A N D T H E R A P E U T I C C U LT U R E S and avoid approving drugs with side e√ects. O≈cials at the agency only rarely faced public criticism or congressional inquiry for denying specific medicines to ill people.

In an important departure from the past, government o≈cials had to approve a new drug—or make an exception for clinical testing—before any patient could take it. In order to shore up its scientific and medical legitimacy for this expanded regulatory role, the agency greatly increased its use of advisory committees. Experts with solid research credentials were chosen from outside the FDA to review specific new drug applications as well as general procedures for testing and decision making at the agency.

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