Heparin Aftermath: FDA Told More Foreign Inspections Needed

Safety of drugs made overseas had been questioned; now, 81 Americans are dead.

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The safety of the U.S. drug supply came into question again this week amid allegations by the Food and Drug Administration that contaminated shipments of the blood thinner heparin have been linked to 81 deaths in the United States since January 2007 and many more injuries here and in 10 other countries.

The Chinese government and drug manufacturing firms placed the blame on processing facilities in the United States, but lawmakers called on the FDA to account for the lapses. FDA Commissioner Andrew von Eschenbach appeared before a congressional panel this morning to explain what his agency is doing to ensure the safety and security of the growing number of drugs produced overseas. Although FDA representatives yesterday assured the public that U.S. stocks of heparin now appear to be contaminant free, the lawmakers chastised the agency for not doing enough to thoroughly inspect imported drugs. Some of the legislators advocate an overhaul of the inspection system, including more inspections of overseas facilities.

Fraudulent, shoddy, and contaminated medications manufactured in developing countries have been recognized as a growing threat to worldwide pharmaceutical supplies. The heparin incident, however, may be the first documented case in which a contaminated, foreign-produced drug has actually killed Americans.