Pharmaceuticals Marked ‘Returned’ to Be Seized : U.S. Acts to Curb Illegal Drug Imports

WASHINGTON —  Federal officials said Friday that they would order a new series of inspections designed to crack down on illegal imports of counterfeit and adulterated pharmaceuticals by drug “diverters.”

Customs Service agents will be instructed to seize all shipments marked as “returned” drugs made in the United States, and Food and Drug Administration officials will inspect the drugs’ packaging and quality, according to a statement issued by the office of Rep. John D. Dingell (D-Mich.). FDA officials said the action will take effect within two weeks.

Until now, such shipments have been allowed to enter this country free from inspection. U.S. officials said that drug diverters have used the exemption to import drugs that are often unsafe and ineffective, such as the subpotent Ovulen birth control pills that reached the California market last year.

Reducing Health Threat

Dingell, who issued a report in July that said the government had “lost control” of the pharmaceutical market, predicted the new inspections could go far in reducing the health threat posed by diverted drugs from abroad.

But an aide to Dingell said the congressman will propose legislation to address the even bigger domestic diversion market, which he said threatens the economy of the drug industry.

The import alert will order officials to stop all pharmaceuticals marked “American Drugs Returned” until the shipment can be properly inspected by the FDA, said Richard Klug, the agency’s director of import operations. Klug said he expects up to 1,000 shipments a year to be stopped.

Potency to Be Checked

Once the shipment is seized, the FDA will inspect the drugs for proper packaging and quality. Investigators will determine where the drugs have been, if they actually were U.S. products and whether their potency has expired, Klug said.

If the FDA has doubts about the quality of the pharmaceuticals, it will order the importer to put the drugs through a series of tests at an FDA-approved laboratory.

Previously, the FDA had no power to seize suspicious drug shipments, said one agency official, who spoke on the condition that he not be identified by name.

Dingell praised Customs for its plan to seize “returned” drugs, but he criticized the FDA for offering to test only the drugs judged suspicious.

Poisoning Feared

“Even when the drugs are not counterfeit, no one can be sure that sensitive chemical substances sent overseas are shipped, stored or relabeled properly,” Dingell said. “Expired or otherwise adulterated drugs can return to poison Americans.”

Likewise, David Nelson, a staff member of the House Energy and Commerce subcommittee on oversight and investigations, expressed concern that the FDA could miss diverted drugs such as the Ovulen pills, which were meticulously packed.

Nelson said he feared that the FDA would fail to catch the bigger, slicker diverters who can make their drug shipments look as professional as the real thing.

‘Very Stringent Approach’

But Klug asserted that automatic detention of returned goods is “a very stringent approach” and that it would be “nearly impossible” for the FDA to test every shipment.

“It’s judged to be a problem of enough seriousness that we want to hold it up and see exactly what we’re dealing with,” Klug said. “If most of them are legitimate . . . then the problem isn’t very serious.”

Klug called Dingell’s concerns legitimate but he said most of the drugs returned to the United States are just what they are claimed to be. American companies that sell drugs abroad often have unused portions legitimately returned to them, he said.