WASHINGTON -(Dow Jones)- House lawmakers and government auditors said Tuesday that the U.S. Food and Drug Administration has serious gaps in its foreign-drug inspection program and can't ensure the safety of the U.S. drug supply.
The issue of foreign-drug facility inspections was the subject of a House Energy and Commerce Oversight and Investigations Subcommittee hearing in the wake of contamination problems with Baxter International Inc.'s (BAX) blood- thinner heparin, which has been linked to hundreds of serious allergic reactions and as many as 81 deaths. FDA officials have said the contamination, which was found in the active ingredient used to make heparin, had occurred in China where ingredients are extracted from pig intestines.
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