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Medical liability reform

This article was originally published in The Tan Sheet

Executive Summary

Language granting liability protection for manufacturers of FDA-compliant drugs might not be included in Senate version of HEALTH Act (HR 5), according to Alan Eisenberg, health and economic policy advisor to Rep. James Greenwood (R-Penn.). Speaking April 2 at FDLI's Annual Educational Conference, Eisenberg said he is "hopeful, but not fully optimistic, that any legislation worked on by the Senate will be as broad in scope" as HR 5, which passed the House March 13 (1"The Tan Sheet" March 17, 2003, In Brief). He noted several Democrats have indicated they are reluctant to extend liability protections to manufacturers, place caps on punitive damages. If product liability provision is excluded from Senate bill, staffers may try to put it back into final language during conference, Eisenberg added...

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Medical liability bill

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...





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