WASHINGTON — A compound related to a common nutritional supplement has been identified as the contaminant in a blood-thinning drug imported from China that sickened hundreds of frail patients in the U.S. and is suspected in a number of deaths, federal officials said Wednesday.
The substance mimics the real drug -- heparin -- in standard safety tests and may have been deliberately substituted for the genuine compound somewhere along the line to boost middlemen's profits. It could also have been added through a mishap or some kind of misguided experiment. Because of difficulties in back-checking, it's unclear whether Food and Drug Administration officials will ever know for sure.
The FDA's announcement came days after the anniversary of last year's massive recall of contaminated pet food. In that case, the agency found that a chemical added to pet food ingredients from China had sickened thousands of dogs and cats, many of which died.
The recall inflamed public concerns about the safety of consumer goods from China; the heparin investigation may give a boost to legislation stalled in Congress that would set up a much more rigorous import inspection system.
"It is unacceptable that Americans have died and been seriously injured by what appears to be deliberate tampering," Sen. Edward M. Kennedy (D-Mass.), who chairs a panel that oversees the FDA, said in a statement. "Whether this contaminant was introduced intentionally or by accident, the full force of the law must be brought to bear to bring those responsible to justice.
"To guard against future abuses, every drug manufacturer needs to inform FDA of where it sources its ingredients and what it is doing to ensure that these ingredients are pure and potent."
Benjamin L. England, a former FDA lawyer involved in enforcement matters, said there had been past cases in which manufacturers and suppliers used unapproved materials to boost production capacity or to save money.
"This is not a new problem," said England, who now advises foreign companies on how to comply with U.S. regulations. "This is a close cousin of problems that have presented themselves before."
The FDA is chronically short of resources to meet its mandate to oversee a vast array of drugs, medical devices, and processed and natural foods. Inspections of foreign producers in particular are infrequent. And China has been difficult territory for U.S. regulators.
