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FDA launches pilot project to oversee foreign drug products
January 17th, 2009 by Jennifer Walker-Journey
The FDA announced today that it will launch a voluntary two-year pilot program to help promote the safety of drugs and active drug ingredients made outside the U.S. As part of the Secure Supply Chain program, the FDA will select 100 volunteers to maintain control over drug products beginning with when they are produced until it enters the U.S.
The program is designed to assist the FDA in its efforts to “prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and may not be compliant,” according to the FDA press release.
“This initiative creates incentives for drug makers to develop and maintain secure supply chains,” said Deborah Autor, Director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in the press release. “This is one of several agency initiatives to enhance drug product safety.”
The pilot program compliments the agency’s recent placement of offices in foreign countries to oversee quality control standards of foods and drugs imported into the U.S. The efforts likely stem from scrutiny the agency received last year after batches of heparin produced in China were found to have been contaminated. The tainted heparin killed more than 80 people and sickened hundreds more before an investigation revealed that the heparin was most likely contaminated during manufacturing at Baxter International’s China plant. The finding led to an FDA recall of specific lots of heparin.
In the months following the heparin scandal, the FDA has come under fire from lawmakers and advocacy groups for not adequately inspecting foreign food and drug manufacturing plants, and for mishandling the contaminated heparin investigation.
