Tag Archives: Drug Safety

Hatch-Waxman and Defective Generic Drug Labels: The Disjunction Between Federal Drug Safety Law and State Warning Defect Law (Part II)

by Bernard Bell — Monday, June 4, 2018

In an earlier post I outlined a regulatory anomaly regarding liability for defective drug labels.  Hatch-Waxman expedited entry of generics medications into the market, by relieving generic-brand manufacturers of the need to conduct further testing.  Concomitantly, the statute placed control of the contents of the drug label in the hands of the original recipient of […]

Hatch-Waxman and Defective Generic Drug Labels: The Disjunction Between Federal Drug Safety Law and State Warning Defect Law (Part I)

by Bernard Bell — Tuesday, May 29, 2018

Consider the following hypothetical.  A drug company develops and patents a pharmaceutical to sell under brand-name.  It secures FDA approval and enjoys its patent monopoly for many years.  But after that patent monopoly expires, generic brand-makers flood into the market and undercut the brand-name’s price.  Pharmacists substitute the generic for the brand name.  The label […]