GAO report to Congress suggests FDA severely underfunded
WASHINGTON A Government Accountability Office report on foreign-drug inspection delivered to Congress Tuesday suggested that the FDA is woefully underfunded in its mission to regulate the manufacture of medicines outside the U.S.
The issue has come to a head in light of the distribution of the contaminated blood-thinner heparin out of a Chinese facility that had escaped FDA inspection.
The report, delivered to Congress by Marcia Cross, GAO director of health care, estimated that the FDA would need to spend between $67 million and $71 million annually in order to reach the minimum requirement of biennially inspecting the 3,249 foreign drug establishments identified by the FDA.
And those are conservative estimates, Cross noted—there may be more manufacturers that should be inspected than the FDA currently has on its roll call. Where the FDA’s Drug Registration and Listing System lists more than 3,000 foreign establishments as registered with the FDA in fiscal year 2007, FDA’s Operational Administrative System for Import Support system has indicated that about 6,800 foreign establishments actually offered drugs for entry into the U.S. last year.
With each inspection costing the government more than $41,000, that would effectively double the FDA’s minimum requirements necessary to inspect each facility every two years—to almost $145 million—if the OASIS figures were used instead of the DRLS. “FDA’s databases do not provide an accurate count of foreign establishments subject to inspection,” commented Cross during a Congressional hearing.
Under current budgetary constraints, data from the FDA suggested that the agency may inspect approximately 8 percent of foreign establishments in a given year. “At this rate, it would take FDA more than 13 years to inspect each foreign establishment once, assuming that no additional establishments require inspection,” Cross said.
The GAO report seems to support critics of FDA’s chronic underfunding—President George Bush’s fiscal 2009 budget allotted $2.4 billion to the FDA, an in increase of 5.7 percent. (see Drug Store News March 3 cover story).
And it’s an issue that commissioner Andrew von Eschenbach has publicly stated could possibly place the FDA mission—protecting America’s food and drug supply—in danger of not being executed effectively. (see related Drug Store News March 17 cover story).
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.