US lawmakers rip FDA over unapproved import drugs

Reuters

June 24, 2003

WASHINGTON, June 24 (Reuters) - U.S. lawmakers criticized the Food and Drug Administration on Tuesday for not aggressively policing the import of prescription drugs and stopping the entry of illegal knock-offs and counterfeit medicines.

Members of the House Oversight and Investigations Subcommittee said the FDA's enforcement had been stagnant since Congress held a similar hearing in 2001.

They cited the FDA's actions last month in letting through unauthorized versions of the anti-impotence drug Viagra, after the shipment was detained by customs officials.

"Given the exponential increase in the volume of drugs being imported into the U.S., FDA's current approach must be substantially altered," said subcommittee Chairman Rep. Jim Greenwood, a Pennsylvania Republican.

But some lawmakers said the entry of cheaper imports would be impossible to stop while U.S. drug prices remained so high.

"We have done nothing to control the price of drugs," said Illinois Democrat Rep. Jan Schakowsky said. "Is it any wonder that people are turning to other places to get it?"

The U.S. Senate backed a measure last week that would allow experimentation with imports of U.S.-approved pharmaceuticals from Canada but it would require safety certification from U.S. officials who have failed to endorse previous import plans.

About 60 million pharmaceuticals enter the United States through mail annually, an increase of 1,000 percent since 2001, Greenwood said.

Mail importation is currently allowed for serious conditions where a drug is not available in the United States.

But a wide range of common prescription drugs can be bought outside the United States and online, including cholesterol-lowering drug Lipitor and Procrit, an anemia treatment given to cancer and HIV patients. Pfizer Inc. PFE.N markets Lipitor and Johnson & Johnson JNJ.N markets Procrit.

The FDA's critics say it has turned a blind eye to imported pharmaceuticals that can be as much as 90 percent cheaper than those bought at home but may turn out to be counterfeit and offer no health benefits.

In some instances, foreign companies sell drugs that have expired dates, have an incorrect dose or have no medicinal value, rendering them as effective as sugar pills, said FDA Associate Commissioner William Hubbard.

Since the Miami incident involving unapproved Viagra, another Pfizer drug, the agency has launched an internal investigation and is training its investigators to identify imported drugs, FDA Associate Commissioner John Taylor testified.