Making "me-too" drugs benefit the public.
The Food and Drug Administration (FDA), in its review of pharmaceuticals for safety and effectiveness, has relied heavily on placebo-controlled studies. In their prescribing practice, physicians often face clinical decisions between several FDA-approved drugs for the same indication, with little guidance from the FDA on the similarities or differences of the drugs. The public could benefit if the FDA were more proactive in declaring, when applicable, that the best available evidence does not indicate any significant clinical advantage for a particular FDA-approved drug compared with others.
Nusbaum
Neil J
NJ
VA Capitol Health Care Network, Martinsburg, WV, USA. NusbN@aol.com
D003363:Cost Control; D017277:Drug Approval; D004358:Drug Therapy / Q000191:economics*; D006801:Humans; D033181:Information Dissemination; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration