Bextra On Capitol Hill: FDA’s “Turning Point” Or Another Sign Of Failure?
Executive Summary
FDA's request for Pfizer to withdraw the COX-2 inhibitor Bextra could signal a new era of strong decision making at FDA, Senate Finance Committee Chairman Charles Grassley (R-Iowa) declared
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Speaker Hastert adds health policy advisor
House Energy & Commerce Committee Chief Health Counsel Chuck Clapton joins the office of Speaker Dennis Hastert (R-Ill.) as policy adviser for healthcare and social security issues. Clapton was with the E&C Committee when Billy Tauzin, now CEO of PhRMA, served as chairman. Clapton has supported FDA, even when the agency faced strong criticism from others for its handling of drug safety. Following the COX-2 inhibitor fallout on Capitol Hill, Clapton stated that FDA was doing a "very good job" and that there was no need for "sweeping or comprehensive reforms" (1"The Pink Sheet" April 11, 2005, p. 15)...
Speaker Hastert adds health policy advisor
House Energy & Commerce Committee Chief Health Counsel Chuck Clapton joins the office of Speaker Dennis Hastert (R-Ill.) as policy adviser for healthcare and social security issues. Clapton was with the E&C Committee when Billy Tauzin, now CEO of PhRMA, served as chairman. Clapton has supported FDA, even when the agency faced strong criticism from others for its handling of drug safety. Following the COX-2 inhibitor fallout on Capitol Hill, Clapton stated that FDA was doing a "very good job" and that there was no need for "sweeping or comprehensive reforms" (1"The Pink Sheet" April 11, 2005, p. 15)...
Bextra, Vioxx Require Stronger Warnings, Additional Study, Cmte. Finds
Pfizer's Bextra requires additional clinical trials to clarify an observed cardiovascular signal, a joint FDA advisory committee on COX-2 inhibitor safety said