FDA NEEDS MORE OVERSEAS INSPECTORS

Pharmacy Times, Volume 0, 0

The FDA is under increasing pressurefrom Congress to beef up its foreigninspections program to improve the safetyof imported medicines, especiallythose from China and India—major producersof active pharmaceutical ingredientsand finished drug products.

The Department of Health and HumanServices recently announced a memorandumof agreement with China to improvethe safety of imported food, drugs, andmedical devices, but Congress is continuingto press the issue.

"While I am pleased that [FDA] Commissioner[Andrew] von Eschenbach hastaken our advice to open FDA officesoverseas," said Rep John Dingell (D, MI),chairman of the House Energy andCommerce Committee. "This is just onestep in a long road towards improvingfood and drug safety."

Responding to concerns over the FDA'sfailure to inspect a Chinese plant manufacturing1 of the ingredients in the bloodthinner heparin which has been tied tohundreds of allergic reactions, Dingellsaid: "These heparin tragedies are likelythe result of FDA abandoning its preapprovalinspection requirement, a criticalpolicy that was put in place two decadesago." He and Rep Bart Stupak (D, MI), whochairs the Subcommittee on Oversightand Investigations, are considering emergencylegislation that would prohibit themarketing of any drug from a plant thathas not been properly inspected.

In March, the FDA received approvalfrom the State Department to establish 8full-time, permanent FDA positions at USdiplomatic posts in China, pendingauthorization from the Chinese government.