FDA Post-Marketing Clinical Trial Authority Should Be Bolstered, Topol Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Cleveland Clinic researcher Topol's suggestion is part of a JAMA editorial critical of COX-2s following Pfizer's announcement that Celebrex demonstrated an increased cardiovascular risk in a cancer trial. Topol advocates for second-line use and a contraindication in high-risk patients.
You may also be interested in...
Pfizer Celebrex Polyp Trial Shows Increase In Cardiovascular Events
The Adenoma Prevention with Celecoxib trial found an increased CV risk for patients taking 400 mg and 800 mg Celebrex compared to placebo; a second study showed no increased risk. The APC study results mean Pfizer can no longer promote the COX-2 as being clear of cardiovascular signals.
Sen. Grassley Plans Legislation On Independence Of FDA Drug Safety Office
Finance Committee chair acknowledges he does not have enough votes for such legislation but says he is starting the "process of educating my colleagues" and "intends to continue that until we get this job done." Grassley's requested GAO report on the Office of Drug Safety will take several months.
Able Unable To Reform On Its Own? Firm Seeks Consent Decree To Address Manufacturing Issues
“We are prepared to enter discussions toward a decree at FDA’s earliest convenience,” Able says in letter to FDA. Company is pursuing consent decree instead of responding to FDA Form 483 report citing manufacturing deficiencies. The letter follows CEO Maury’s resignation the previous day.