title: Clinical testing of products prepared by biotechnology.
abstract: In summary, new therapeutic products derived from biotechnology will have to satisfy all the usual demands of regulatory agencies, plus some new requirements generated by their special nature. The chemical identity and purity of rDNA compounds will have to be assured, animal toxicity testing will be required, and sufficient data on clinical safety and efficacy will have to be gathered to justify FDA approval. In this process, empiricism will be the key word. NDAs will be approved on the basis of facts, and not theory, and that is as it should be. How costly will this process be? Part of the process is more or less under the control of the sponsor, i.e., the part leading up to the filing of the NDA. Trials can be organized and carried out efficiently or inefficiently; the difference will be measured in years and millions of dollars. The same generality can be applied to the preparation of the inevitably voluminous NDA. Two final worries: Litigation and damage awards are threatening the stability of much of our society. The trend toward holding pharmaceutical manufacturers responsible for strict product liability, not negligence, is fearsome, since it is not possible to protect oneself against harm which cannot be predicted or prevented. Unforeseen serious adverse effects with an rDNA product involving thousands of patients could spell bankruptcy for a biotechnology company. The last issue is what I will term the "biotechnology Chernobyl disaster".(ABSTRACT TRUNCATED AT 250 WORDS)
mesh_terms: D001709:Biotechnology; D002617:Chemical Industry; D003365:Costs and Cost Analysis; D004275:DNA, Ribosomal; D013006:Growth Hormone / Q000627:therapeutic use; D006801:Humans; D007328:Insulin / Q000627:therapeutic use; D007376:Interleukin-2 / Q000627:therapeutic use; D007880:Legislation, Drug; D011994:Recombinant Proteins / Q000627:therapeutic use; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004275:DNA, Ribosomal; D007328:Insulin; D007376:Interleukin-2; D011994:Recombinant Proteins; D013006:Growth Hormone