Unhappy with the answers he was getting, Dingell told FDA officials they should be "embarrassed" by their testimony and stressed the agency needed to become a tougher watchdog. "You folks are more trusting than a kindergarten class," he said.
Later, Woodcock and Autor provided the specifics about extra funding and authority. "Hallelujah," Stupak said after the FDA officials detailed needs. "We're making progress."
Heparin is widely used during kidney dialysis and open heart surgery to prevent dangerous clots from forming. After scattered reports of serious side effects, Baxter International recalled most of its heparin products in February. Baxter had gotten a tainted ingredient from a plant in eastern China jointly owned by a Wisconsin company, Scientific Protein Laboratories.
The hearing began with relatives of three victims describing in tearful detail how routine dialysis led to trouble breathing, severe diarrhea and chest pain, and death.
Leroy Hubley of Toledo, Ohio, recalled how hospital doctors took his wife of 48 years, Bonnie, off life support in December while Christmas music played in the background. A few weeks later, his son Randy, 47, died, also from the side effects of heparin.
Baxter and SPL executives apologized to the families. The company officials blamed Chinese suppliers and stressed that standard quality testing couldn't detect the contaminant.
Last September, Baxter inspected the plant in Changzhou, China, and deemed the facility OK after getting one problem fixed. Five months later, as the heparin scare intensified, an FDA inspector visiting the same plant found numerous violations of good manufacturing practices.
jonathan.rockoff@baltsun.com
