FDA's WLF Reply Cites Legislative Record As Support For Off-Label Position
This article was originally published in The Gray Sheet
Executive Summary
Judge Royce Lamberth's decision on the off-label dissemination provisions of the FDA Modernization Act should accord "deference" to Congress' careful consideration of "substantial evidence" when crafting the statute, FDA argues in a reply to the Washington Legal Foundation's April 29 brief filed in WLF v. Henney.