Are newer scientific concepts in regulatory toxicology used timely and appropriately?
Laws regulating toxicology (e.g. toxic thresholds allowed, poison classes or definition of necessary preclinical testing) might improve health and save lives. Scientific facts will always serve as a mandatory base for political decision-making, but there will also be additional influences (perception and acceptance of risks, possible benefits, economic considerations etc.). These latter factors may vary considerably from one society to another. The Delaney clause prohibited the marketing of any product which was found to be carcinogenic in animals. Due to their benefits, exceptions were made for drugs. In other countries, too, other chemicals could be an exception due to a different perception of the risk or different scientific evaluation. Clear cases of major events always trigger changes in legislation. When in 1937 a newly-marketed sulfanilamide elixir led to severe kidney damage and 70 deaths, the FDA quickly endorsed the propositions of the investigation team set up by the American Medical Association: animal testing in two species with histopathologic examination before a marketing authorization could be granted became mandatory. A similarly rapid reaction followed in Europe when it was detected that Thalidomide was responsible for malformations in the offspring of mothers who had taken the drug in early pregnancy. When the effects are more difficult to link to a chemical, there may be time delays in regulatory actions. However, a sophisticated evaluation system was introduced for better monitoring of drug and chemical hazards. Some examples will be given in order to discuss the difficulties of timely and appropriate use of scientific findings.
Hodel
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Sterling Winthrop Pharmaceuticals Research Department, Longvic, France.
Bass
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D000818:Animals; D002110:Caffeine / Q000633:toxicity; D015197:Carcinogenicity Tests; D006801:Humans; D007880:Legislation, Drug; D012307:Risk Factors; D013424:Sulfanilamides / Q000633:toxicity; D014116:Toxicology / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration
D013424:Sulfanilamides; D002110:Caffeine