Thousands of Americans who order prescription drugs from Canada have received written notice that their medications have been seized, part of a US government crackdown on the cross-border discount trade.
The increase in seizures and the strong legal warnings issued to consumers mark a shift in policy for the Bush administration, which until now has rarely acted against individuals who buy drugs from Canada. The enforcement policy, which began last fall, is drawing fire from members of Congress.
Nancy Popkin, a Salem resident who has been ordering the osteoporosis treatment Fosamax from Canadian pharmacies for years, was one of those recently targeted. Popkin said she was surprised when, instead of her usual shipment of 12 tablets, she was mailed a form letter accompanied by a flier featuring a snake coiled around a drug bottle.
The notice, from the Department of Homeland Security, US Customs and Border Protection, said her medication had been seized because ''virtually all" drugs imported by individuals into the United States are unapproved for consumption here or are dispensed without a valid prescription. The letter cited a federal statute, although there is no penalty for violating it.
Popkin was warned that only drug makers can import prescription medications from foreign countries -- even if they were manufactured in the United States.
''The implication is that I have done something illegal, unpatriotic. I think it's ludicrous," she said.
Federal officials say they have become increasingly concerned about the quality of drugs entering the United States from Canada, but did not indicate how many shipments have been intercepted since the stricter policy was implemented in November.
''What we're trying to do is protect the public from unsafe medications," said Lynn
The policy applies only to mail-order shipments, not to US citizens who cross into Canada to pick up their drugs, she said. Consumers are given the option of allowing their drugs to be destroyed, or to ask for a Food and Drug Administration review of the medications to determine whether they are legal.
US Senator Bill Nelson, a Florida Democrat and an opponent of the policy, said at least 13,000 packages containing pharmaceuticals were intercepted during the first months of the campaign. The seizures took place in a half-dozen mail inspection facilities across the country, including Seattle -- where Popkin's drugs were found -- Los Angeles, Miami, and New York.
Nelson is among a group of congressional critics from both parties who said they suspect the seizures are part of an effort by the administration to steer seniors to its new Medicare prescription drug plan, called Part D, which has generated confusion since it went into effect Jan. 1.
The enforcement policy began Nov. 17, two days after the enrollment period for the Medicare program opened.
''There's absolutely no connection with this enforcement of federal law with Medicare Part D at all," said Hollinger. ''That's just some kind of misunderstanding."
Congressional critics have also said it is irresponsible to seize potentially life-saving drugs ordered by American citizens.
''It would be devastating if someone gets sick or dies because someone's drugs were confiscated," said US Representative Gil Gutknecht, a Minnesota Republican who has been a staunch supporter of imported drugs.
''It is amazing that we have a government that can't control our borders to illegal immigration and literally tons of illegal narcotic drugs that are coming into this country every day, but by God they can stop Grandma from saving $50 on her prescription drugs," he said.
People whose drugs have been seized should contact their doctors for new prescriptions.
The Food and Drug Administration, which in the past several years has taken the lead on warning seniors against imports, declined comment and referred questions to the Customs agency. The FDA has said imports from Canada expose Americans to potentially tainted, counterfeit, or ineffective drugs. In a letter to members of Congress this month, it said half of the shipments it seized recently from Israel, India, Costa Rica, and the South Pacific island of Vanuatu were from websites purporting to be Canadian pharmacies.
Canadian pharmacy operators say many Americans continue to purchase their drugs from Canada and Europe, even with the availability of Medicare drug coverage, because the prices are lower when monthly Medicare premiums and deductibles are added.
Popkin said her Fosamax from BestBuyRX.com in British Columbia cost $114 for 12 tablets -- a three-month supply -- or $456 annually. Under Medicare drug coverage, which requires a one-year commitment to an insurance plan, the least expensive year's supply available was $440, according to the Medicare website.
But Popkin said that because she takes only one drug, the lack of flexibility and the cost of the monthly premiums and deductibles associated with Medicare made it more expensive than buying from Canada.
Since her shipment was seized, Popkin said, she will no longer buy Fosamax from outside the United States because she is concerned about legal exposure. She recently paid $222 for a three-month supply at a
She called the government's warning letter and graphic poster an attempt to frighten seniors. ''I don't go for that kind of baloney," said Popkin, a financial adviser in her 70s. ''But think how many people get scared out of their wits."
Federal officials have long sought to protect the rights of the pharmaceutical industry to charge higher prices in the United States.
While warning against the potential dangers of receiving counterfeit medications from cross-border or offshore pharmacies, the FDA has adopted an official policy of not prosecuting individuals and families who import drugs for their own use.
There have been spot seizures, particularly of drugs sent by pharmacies in countries other than Canada, but Canadian pharmacists estimate that enforcement is now about 10 times as aggressive.
''It appears since the Medicare Part D has come in, that there is a substantial increase in the number of packages being stopped or seized," said Sukhi Grewal, director of BestBuyRx.com.
Christopher Rowland can be reached at firstname.lastname@example.org.