80% of chemicals for U.S. prescription drugs imported GAO says safety, purity not adequately policed

WASHINGTON — WASHINGTON -- Nearly 80 percent of the chemical ingredients for prescription drugs sold in the United States are imported, but federal investigators say in a new report that the government has failed to police the safety and purity of the products shipped to this country.

The General Accounting Office, the congressional investigative agency, said federal authorities did not even have a complete, accurate list of foreign companies supplying chemicals to drug makers in the United States.


Moreover, the report said, the foreign suppliers are inspected much less frequently than domestic companies. Most foreign factories have never been inspected by the Food and Drug Administration, whereas this country's factories must be inspected every two years. And the report said the foreign firms appeared to get more lenient treatment from the FDA.

At a chemical-synthesizing plant in China, an FDA inspector wrote, "virtually all of the equipment for the first phases of processing is filthy, in an extreme state of disrepair."


Another plant, in India, shipped herbicide to the United States in drums labeled as containing pharmaceutical chemicals, and the "possible fraud" was discovered only when the American manufacturer tried to use the materials to make pills and they broke apart, the GAO said.

When FDA inspectors find violations and recommend penalties against foreign companies, the recommendations are often overruled by officials at the agency's headquarters, the report said.

In addition, it said, federal officials often do not reinspect the foreign companies to see whether they have corrected deficiencies, and "this impairs FDA's ability to insure that American consumers are protected from potentially serious health risks posed by adulterated drug products."

The study had been requested by Rep. Joe L. Barton, a Texas Republican who heads the House Commerce Subcommittee on Oversight and Investigations.

"There should not be a double standard on drug safety because of where the product was made," Barton said. "It appears there is a tougher standard on domestic manufacturers than on foreign drug manufacturers."

The challenge of dealing with imported drug ingredients is similar to the problems the government has had coping with food products and food-borne illnesses in a global marketplace where trade is booming.

Food imports to the United States have soared, but federal inspections of these imports have dropped. Officials continually wrestle with questions about how to expand trade without lowering health and safety standards.

Under federal law, the FDA must inspect drug makers' domestic production plants every two years, but there is no such requirement for foreign suppliers. The food and drug agency "acknowledges that it may never inspect most foreign manufacturers exporting pharmaceutical products to the United States," the accounting office said.


"Routine inspections of foreign pharmaceutical manufacturers," the report said, "occur with far less frequency than the two-year interval required for domestic manufacturers."

Auditors found that four to five years typically elapsed between routine FDA inspections of companies in China and India supplying chemicals to drug makers in the United States.

Commenting on the report, Diane Thompson, associate commissioner of the FDA, said there were "unique difficulties" in inspecting drug production plants overseas. But she said the agency was trying to do a better job.

The General Accounting Office report also made these points: About 3,200 foreign companies have informed the FDA that they intend to ship pharmaceutical products to the United States, but only 1,100 have been inspected. "FDA officials could not explain why the remaining 2,100 firms had not been inspected."

Serious violations of federal standards were found much more often at foreign production sites than at factories in this country. But the FDA frequently failed to take prompt enforcement action against the foreign companies, whose problems included the use of polluted water and a lack of quality controls.

At a pharmaceutical plant in India, an FDA chemist found "incompetence bordering on fraud," and inspectors recommended that the company's products be barred from the United States. But senior FDA officials rejected the recommendation and "accepted the manufacturer as a supplier of bulk pharmaceutical chemicals without verifying that it had corrected deficiencies" in its testing procedures.


Information on foreign drug companies is scattered among 15 different computer systems at the FDA, so data on prior violations and enforcement actions are not readily available to the people who need it.

The General Accounting Office said that FDA inspectors had often proposed citing foreign companies for serious violations of federal safety standards but that in many cases officials at FDA headquarters "downgraded the severity of inspection findings," so penalties were reduced or eliminated.

Pub Date: 5/03/98