title: History and regulatory issues of generic drugs.
abstract: In the November 1987 edition of the Journal of the Society of Clinical Pharmacology and Therapeutics, Dr Richard Weinshilboum of the Department of Pharmacology at the Mayo Clinic made the following observation: "The past half century has been a golden age for pharmacologic therapy. Fifty years ago there were no antibiotics: there were no antihypertensives; there were no antineoplastics; there were no antipsychotics; there were no antidepressants; and the list could go on and on. With the exception of a few effective drugs, the pharmacopeia of that time was filled with placebos. Our generation has witnessed the transformation of medicine. A transformation due in part to the development of drugs capable of controlling or curing diseases that have plagued mankind throughout human history." There is plenty of room for both the innovator and generic manufacturer in this market, but both sides need protection. The regulations adopted by the FDA for providing a safe and effective route to drug approvals will foster both sides while maintaining its primary purpose, assurance to the public that the products they consume have been adequately studied and appropriately applied.
mesh_terms: D017277:Drug Approval / Q000266:history; D016568:Drugs, Generic / Q000266:history / Q000493:pharmacokinetics / Q000592:standards*; D049673:History, 20th Century; D006801:Humans; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration