Effort planned to block unapproved drug imports in mail

WASHINGTON -- A major operation is planned this summer at international mail centers to counter a flood of counterfeit and unapproved drugs entering the country, the government said Tuesday.

Scientists and inspectors will target, examine and test packages, Elizabeth Durant of the Bureau of Customs and Border Protection told the House Energy and Commerce subcommittee on oversight and investigations.

Subcommittee chairman Rep. James Greenwood, R-Pa., observed that the Miami international mail facility alone receives as many as 7 million packages containing drugs annually, a flow that has increased sharply in recent years as a growing number of people order pharmaceuticals through the mail.

William Hubbard, associate commissioner of the Food and Drug Administration, presented a selection of drugs people had bought through the mail that turned out to be illegal, counterfeit or simply to have no active ingredient at all.

Counterfeit drugs can be fake products or may be generic copies of a real drug made and sold without FDA supervision or approval. Counterfeit drugs have long been problems in parts of the world. One study found one-third of malaria pills tested in parts of Asia contained no medication.

One Internet site that sells drugs shows an address in the United States but operates out of Thailand, Hubbard said. Another that claims to be Canadian ships drugs from India.

The FDA has no way to monitor the quality of drugs made abroad, Hubbard said, and in many cases what arrives has improper labeling or has not been properly stored or handled.

One man spent $1,500 for a four-year supply of a drug that has an expiration date in August, he said, and another received a vial containing tap water instead of the vital drug claimed on its label.

Durant said the FDA works with her agency in the effort to combat importation of drugs.

She did not detail the blitz campaign planned for this summer other than to say the two agencies plan to target both mailed drugs and travelers trying to bring in pharmaceuticals when they return to the United States.

Rep. Peter Deutsch, D-Fla., criticized the FDA's efforts in Florida. He said a staggering amount of drugs was entering the country without agency scrutiny.

"Thanks to a lack of leadership by (the Department of Health and Human Services) to devise some meaningful guidance for field staff, the Miami facility has become a shock and awe version of FDA mismanagement," Deutsch said.

In particular, Rep. John Dingell, D-Mich., was critical of the agency for first holding and then releasing 1,233 shipments of imported generic Viagra. The agency then scrambled to warn purchasers that the drug was unapproved and might not contain the real chemical.

Viagra remains under patent protection, so any generic version automatically would be counterfeit under U.S. law and should not be allowed to be sold in this country.

John Taylor III, associate FDA commissioner, said the agency is reviewing what happened with that batch of drugs to ensure the mistake doesn't happen again.