Vioxx Promotions, Labeling Revisions Are Focus Of Drug Safety Hearing
This article was originally published in The Pink Sheet Daily
Executive Summary
Three FDAers and Merck VP Erb will testify at the House Government Reform Committee hearing May 5. The committee suggests that creation of a Drug Safety Monitoring Board will not resolve all concerns with FDA’s post-marketing surveillance.
You may also be interested in...
House Investigation Of COX-2 Promotional Practices Turns Attention To Pfizer
Government Reform Committee members discuss extending their investigation on Vioxx promotional practices to other COX-2 drugs. FDA Office of New Drugs' Jenkins rebukes Merck for avoiding discussion of certain cardiovascular risk data during physician detailing visits before a 2002 Vioxx labeling change.
House Investigation Of COX-2 Promotional Practices Turns Attention To Pfizer
Government Reform Committee members discuss extending their investigation on Vioxx promotional practices to other COX-2 drugs. FDA Office of New Drugs' Jenkins rebukes Merck for avoiding discussion of certain cardiovascular risk data during physician detailing visits before a 2002 Vioxx labeling change.
FDA Safety Act Proposes Fines For Failure To Comply With Drug Safety Office
Center for Postmarket Drug Evaluation & Research would be able to levy fines starting at $250,000 for failure to complete postmarketing studies on time and for failure to comply with "corrective actions" under the legislation. FDASA would give the independent drug safety office authority over labeling changes and promotional materials.