Healthy Skepticism Library item: 7623

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

Wechsler J.
The push for generics challenges manufacturers
Pharmaceutical Technology 2003; 27:(7):26,28,30,32,34

Abstract:

The campaign to establish an affordable Medicare prescription drug benefit is encouraging both the White House and Congress to explore ways to control drug spending. One strategy is to promote the increased use of less-expensive generic drugs by speeding regulatory approval of new generics and reducing protracted patent disputes between brand-name and generics manufacturers. Another initiative that reduces health plan and insurer coverage of pharmaceuticals is to spur manufacturers to switch more prescription drugs to over-the-counter (OTC) status. FDA’s Center for Drug Evaluation and Research (CDER) is responsible for implementing policy changes governing generic, OTC, and innovator drugs while also revising operations to accommodate the oversight of biotech therapies.