FDA Has "Substantial Interest" In Reviewing Off-Label Uses, Judge Rules
Executive Summary
FDA has a "substantial interest" in adding off-label uses of previously approved drugs to product labeling, D.C. federal court Judge Royce Lamberth ruled July 30 in the first amendment case brought against FDA by the Washington Legal Foundation.
You may also be interested in...
Drug Companies Should Sue Competitors For Off-Label Promotion
Drug companies should challenge off-label promotion by competitors in the same way they defend their patents against infringement, U.S. Attorney Michael Loucks said
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011