Therapeutic equivalents in clinical practice.
With increasing debate over the rising expenses of health care, a variety of cost-saving measures has been attempted over the years. Use of primary care physicians as "gate keepers," reduction in the length of hospital stays, and pushing women toward vaginal birth after Cesarean section have all been utilized despite on going issues with patient satisfaction and even safety. One remarkable success in stretching health-care dollars that has often been overlooked is the prescription of therapeutic equivalents, or generic drugs. Although available on a limited basis for decades, off-brand manufacture of pharmaceuticals with identical active ingredients as those of the branded drug received a large boost through Congressional legislation in 1984 with the Hatch-Waxman Act. "Fast-track" FDA approval was initiated by Congress to introduce competition into the marketplace for drugs whose patients had expired. While giving close scrutiny to the manufacturing process and requiring the same level of regulatory supervision for factors such as bioavailability and shelf life, the Hatch-Waxman Act removed the burden and expense from generic manufacturers of proving the safety and efficacy all over again of a previously FDA-approved drug. With less than a 20% market share of all prescribed drugs in 1984, the generic drug industry has captured roughly 44% of the market in recent years while accounting for only 8% of expenditures on prescription medication. The prescription of therapeutic equivalents is one method of keeping health care costs down without compromising patient satisfaction or safety.
Benson
M D
MD
Northwestern University Medical School, Chicago, Illinois, USA.
D017277:Drug Approval; D016568:Drugs, Generic / Q000191:economics*; D017048:Health Care Costs; D006801:Humans; D007885:Legislation, Pharmacy; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D016568:Drugs, Generic