The federal government plans to halt a controversial crackdown on discount drugs mailed from Canadian pharmacies to U.S. customers, removing a significant hurdle to Americans buying cheaper medications from abroad.
The Department of Homeland Security, which operates the Customs and Border Protection agency, disclosed this week that it would halt confiscation of Canadian drugs Monday and instead conduct random sampling to identify counterfeit and unsafe drugs.
Popular medications such as Lipitor and Fosamax can be 30% to 80% cheaper from Canada and other countries, surveys have shown. But the U.S. government was confiscating as much as 20% of the shipments this year.
The move reverses a policy that began last November around the time enrollment began for the Medicare drug plan. U.S. officials said the Canadian shipments had been confiscated out of concerns about the drugs’ safety, but consumer advocates and others contended that the crackdown was an effort to limit competition in the pharmaceutical market and force seniors to sign up for new Medicare plans and pay higher prices for drugs from U.S. pharmacies.
The new testing policy may be a response to criticism that the government has offered little evidence for its safety concerns about foreign mail-order drugs.
The change comes as millions of seniors on Medicare drug plans were expected to hit the “doughnut hole.” That is the gap in coverage created by Medicare law that requires enrollees to pay the full cost after their total annual drug spending exceeds $2,250. Coverage kicks in again if annual drug expenses hit $5,100.
As a result, many low-income seniors were considering going without needed medications through the end of the year, advocates said.
The change in customs’ practices “could have a huge impact,” said Jodi Reid, director of the California Alliance for Retired Americans.
“People were concerned that they might not get their drugs because they were getting seized,” Reid said. “This does open that option again for people who were trying to figure out how to get their medications to manage their health at a price they can afford.”
One Central California woman whose blood pressure medication was seized a few months ago said she was relieved that she might not have to worry about that -- at least for now.
“I hope that it continues because so many people are in need of the ability to purchase maintenance medications and life-sustaining medications at more affordable prices,” said the woman, who asked that her name not be used. “Some of these medications are $3, $4, $10 a pill.”
Although it is illegal for individuals to import pharmaceuticals to take advantage of price differences, the Food and Drug Administration historically had turned a blind eye to personal purchases of nonnarcotic prescription drugs from places such as Canada and Mexico in shipments of as much as three months’ worth.
That changed Nov. 17 when customs began a quiet crackdown on foreign mail-order drugs. By some estimates, more than 40,000 packages were interdicted. Canadian mail-order pharmacies said seizures jumped to a peak this year of 20% of their U.S. shipments, up from 3% to 5%. They said seizures declined after the crackdown was disclosed in media reports.
Seniors complained that they were failing to receive needed medications, and members of Congress who favor the importation of cheap drugs for senior constituents criticized the agency for failing to adequately warn people of the crackdown.
Late Monday, customs officials sent an e-mail to some members of Congress that it would be abandoning the seizure policy. Instead of the broad effort, the e-mail said the agency would sample and test mail-order medications for counterfeits and ineffective ingredients on “randomly generated days throughout the fiscal year.” The analysis, it said, would help determine the source countries of problem drugs and shape future enforcement.
A Homeland Security spokeswoman would not discuss the change in policy, but she issued a statement saying, “While we are reversing this policy, [Customs and Border Protection] remains committed, in cooperation with the FDA, to protecting the American public from unsafe and ineffective medications. We will be focusing our resources to best protect the American public.”
A spokeswoman for the FDA said the agency had no comment because it had not been officially informed of the change.
One Canadian mail-order pharmacy said U.S. orders had dropped 30% this year because seniors were signing up for Medicare plans and had been scared off by the increase in seizures.
Bill Pigden, a spokesman for Winnipeg, Canada-based CanAmerica Global Health Services, said that the pharmacy already had seen orders pick up as seniors fell into the so-called doughnut hole, and that he expected that trend to increase with the change in seizure policy.
Sen. Bill Nelson (D-Fla.) called the change a “huge victory.”
“For nearly a year the White House has been punishing seniors for filling their prescriptions at lower Canadian prices,” he said. “Now it looks like the government is getting out of the business of harassing these consumers.”
In Congress, political momentum in favor of allowing personal importation of prescription medications is building. House and Senate Republicans recently reached an agreement that would allow Americans to bring a 90-day supply of drugs across the border from Canada. But, in negotiations over the language of the Homeland Security spending bill, the conferees stopped short of doing the same for medications purchased via the Internet.