Amid China Fears, the White House Seeks to Broaden FDA's Access to Foreign Plants
BY LAUREN UZDIENSKI, FEBRUARY 26, 2008
Baxter's heparin has been in the news lately following four deaths and hundreds of bad reactions, and with it the revelation that the Chinese plant that manufactured some of the heparin's ingredients had not been inspected by the FDA. Similarly, as reported by the Wall Street Journal (subscription required), China initially resisted FDA inspections of manufacturing facilities in the midst of last year's pet-food recall.
In a letter to two Republican Congressmen, Health and Human Services Secretary Mike Leavitt wrote, "Foreign firms can often deny U.S. officials access to their facilities without any adverse consequences." That may be about to change, as the White House is supporting proposed legislation that would grant the FDA increased power over foreign manufacturing facilities. FDA officials would be authorized to investigate foreign plants, augmenting an earlier proposal that would increase penalties and other enforcement powers against importers.
Though the recent tainted drug, toy and food scandals have not affected medical devices, the new legislation would help to insulate the industry from similar worries, as well as further protect U.S. consumers from dangerous imported products.
