Healthy Skepticism Library item: 9295

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Novitch M.
Implications of global drug development for health care and patients
Drug Inf J 1993; 27:(4):1083-1087

Abstract:

The impact of globalization on drug development issues related to approval of critically important prescription drugs, patient information, and orphan drug research is discussed. The need for quicker approval of therapeutic breakthrough agents has grown considerably through the use of treatment investigational new drugs (INDs) and with regulatory and pharmaceutical efforts to combine Phase II and III studies. The risk to benefit ratio applies to patients and to pharmaceutical firms who may spend up to $230 million on drug development and may afford fewer and fewer failures. Patient education issues must be reviewed by policy makers to examine the existing mechanisms for conveying information to patients. The U.S. Food and Drug Administration has proposed orphan drug rules that would look beyond the molecular structure of new drugs to determine uniqueness and that describe the handling of potential exclusivity.