Two key health reform players introduced legislation that would give the Food and Drug Administration tighter controls over foreign-made prescription drugs and medical devices. Sen. Chuck Grassley (R-Iowa), the ranking member on the Senate Finance Committee, and Sen. Edward Kennedy (D-Mass.), chairman of the Health, Education, Labor and Pension Committee, inked a bill that would boost the number of inspections the FDA conducts overseas. Over five years, the FDA conducted fewer than 1,400 inspections of foreign pharmaceutical plants, Grassley said. An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesnt know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year, he said. The bill also calls for the Institute of Medicine to study the FDAs method for approving devices. Some say the FDA has its work cut out for it in ensuring imported drugs and devices are safe (March 30, p. 28).
Late News: Grassley, Baucus seek tougher controls on foreign-made drugs
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