Medical liability bill
This article was originally published in The Tan Sheet
Executive Summary
Language included in a House Energy & Commerce Committee report on the "Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003" specifies that liability protection for manufacturers of FDA-approved drugs includes OTC products. HR 5, which passed the House March 13, states punitive damages may not be awarded against manufacturers of FDA-approved products unless parties involved in the evolution of the product "cause harm by failing to comply with a specific requirement" of the FD&C Act. OTCs compliant with NDAs, final monographs or tentative final monographs before they are finalized should not be precluded from liability protection, committee's report notes. CHPA lobbied for inclusion of language...