Rep. takes FDA commissioner to task
WASHINGTON House Energy and Commerce Committee chairman John Dingell, D-Mich., blasted Food and Drug Administration commissioner Andrew von Eschenbach yesterday stating that he wasn’t doing his job and hasn’t asked for enough money to inspect foreign drug manufacturers, according to published reports.
Dingell pointed his finger at von Eschenbach and repeatedly asked the FDA chief how much it would cost to conduct more inspections, and the representative even objected when von Eschenbach didn’t provide specific answers.
“You cannot do your job, you are not doing your job,” Dingell told von Eschenbach, who was a witness at the hearing before the energy and commerce panel’s investigations subcommittee. “You simply are absolutely incapable of addressing your responsibilities.”
Von Eschenbach said the FDA is doing more overseas inspections than ever before, although he agreed with lawmakers that still more are needed. He repeatedly said the U.S. must take other actions as well, adding that more frequent inspections wouldn’t have detected the tainted heparin.
According to the Government Accountability Office, it would cost the agency at least $67 million to conduct inspections at the more than 3,200 foreign drug manufacturing sites that the FDA has listed. The FDA, however, only plans to spend about $11 million this year for all foreign inspections.
Contaminated heparin affects 11 countries
WASHINGTON The Food and Drug Administration has announced that the contaminant found in the blood thinner heparin has been discovered in China and has now affected 11 countries including the United States, Canada, Japan, China, Denmark, the Netherlands, Germany, France, Italy, Australia and New Zealand.
Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.
But a Chinese official disputed the assertion that the contaminant found in the drug, heparin, caused any deaths and insisted that his country’s inspectors be allowed to inspect the American plant where the finished heparin vials were made. He said any future agreement to allow American inspections of Chinese firms should be mutual. The agency had announced plans to open inspection offices in three Chinese cities, but the agency has yet to get permission from the Chinese government.
Janet Woodcock, director of the FDA’s drug center, said that German regulators uncovered a group of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had said that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.
Bills to require far more aggressive inspections of Chinese products and companies are being proposed by members of Congress. Hearings are scheduled for today in the House and Thursday in the Senate.
Woodcock said the Chinese had agreed to test heparin lots before allowing them to be exported. But Dr. Moheb Nasr, director of the drug agency’s office of new drug quality assessment, said that the Chinese test might not be sensitive enough to identify the contaminant.
Woodcock assured patients, however, that all heparin supplies in the United States had been tested with the most sensitive tests and had been found to be uncontaminated.
Baxter International, which bought heparin ingredients from Changzhou SPL, the Chinese plant identified as the source of contaminated heparin, sold the finished drug in the United States, and said that its tests confirmed that the contaminant could cause illness. It disputed the FDA’s analysis that its product was linked with 81 deaths, saying it had identified only 5 in which its product “may have contributed to the adverse outcome, though there is not yet enough medical data available to draw a firm conclusion that the reaction caused the death.”
Deaths linked to the drug may have been concentrated in the United States because American doctors may be more likely to use large, quickly infused amounts of the drug, said drug officials.
FDA approves Cimzia for Crohn’s disease
WASHINGTON The Food and Drug Administration today approved Cimzia, a new drug by UCB to treat Crohn’s disease.
Crohn’s disease is a chronic, inflammatory bowel disease. It has no cure and its cause is unknown. Crohn’s can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs.
Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.