US Quality Fears Over Cut- Rate Foreign Drug Supplies

In the last year, the US Food and Drug Administration has found serious manufacturing deficiencies in 35% of its overseas inspections, against 19% at domestic plants. The FDA has increased the number of its inspections at foreign plants from 156 in fiscal 1992 to 325 this year, but a New York Times article questions whether it will be able to keep defective drugs from slipping through, with concern rising as drugmakers try to keep costs down by increasingly turning to lower-priced suppliers abroad.

FDA officials and other experts say almost all imported drugs reaching consumers are safe and effective, with little chance of someone getting a tainted drug. Also, agents are better trained and the length of the inspections has grown. But William Haddad, chairman of Mir Pharmaceuticals and head of the Generic Pharmaceutical Industry Association's international committee, feels the safety concerns are "legitimate," asking whether the FDA has the manpower, with the trade expanding quicker than its ability to respond to it. James Phillips, former special assistant to FDA Commissioner David Kessler, examined the program before leaving the FDA and said: "this thing is like a ticking bomb that could explode at any time."

Drug firms agree they have begun receiving and rejecting more shipments of ingredients that are contaminated with bacteria or fail other tests, in line with the growth of cut-rate suppliers in countries such as India and China. They also say overseas inspections are often shorter and less thorough than domestic ones; FDA documents support this and note that some foreign firms have much less sense of how to meet US safety standards. The FDA has found a rise in counterfeit drug ingredients (products supposedly made at an FDA-inspected plant but really made elsewhere). There are also fears that agents might miss something on their inspections which last only a few days, and concerns over the use of translators provided by the companies being inspected.