Government

U.S. to ease Canadian drug import rule

The bill allows 90-day supplies of medications bought in Canada but still prohibits foreign purchases via mail order or Internet.

By Doug Trapp — Posted Oct. 16, 2006

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Americans traveling to Canada to bring back cheaper prescription drugs soon might no longer need to worry about U.S. Customs and Border Protection seizures.

A provision in the recently passed Homeland Security Appropriations bill will keep border agents from confiscating medication as long as it is a 90-day supply of noncontrolled, Food and Drug Administration-approved prescription drugs.

The measure does not legalize the purchase of drugs from other countries via the Internet or by mail order, said Lynn Hollinger, spokeswoman for U.S. Customs and Border Protection. But Customs on Oct. 4 announced that it will stop seizing mailed packages of imported drugs from Canada as long as they contain noncontrolled, FDA-approved medications and don't look suspicious.

The FDA continues to have reservations about the safety of imported drugs. Consumers who import drugs from other countries are in violation of the federal Food, Drug and Cosmetic Act. While the agency has and may seize their drugs, it has instead focused its enforcement actions on commercial entities illegally importing large amounts of drugs.

House and Senate leaders had reservations about the provision but not enough to upset the delicate balance of compromises ensuring that the Homeland Security spending bill would pass before the elections break.

An aide for Senate Majority Leader Bill Frist, MD (R, Tenn.), said the senator wanted to see more safety provisions in the bill, which President Bush is expected to sign.

Michigan State Medical Society President Paul O. Farr, MD, wasn't as worried. "I've not seen the safety issue [as a problem]," he said. Some fraudulent medication is out there, but as long as patients choose carefully from whom they buy prescription drugs, they shouldn't have a problem.

Dr. Farr said many or most drugs sold in Canada are made in the United States. The difference in price comes from the discounts negotiated by the Canadian government. Those negotiations don't happen here, he said.

A representative of the Maine Medical Assn. said the change was "welcome news." Some doctors in Maine have acquired dual licenses allowing them to prescribe drugs from Canada, said Andrew MacLean, deputy executive vice president of the Maine Medical Assn. For years the AARP and the Maine Council of Senior Citizens have organized bus trips across the border to buy cheaper drugs.

The Vermont Medical Society has not taken a position on drug importation, said spokesman Steve Larose.

The American Medical Association supports the legalized importation of prescription drugs by wholesalers and pharmacies only if:

  • All drug products are FDA-approved and meet all other regulatory and legal requirements.
  • The distribution chain is "closed," and all drug products are subject to reliable, electronic track-and-trace technology.
  • Congress grants necessary additional authority and resources to the FDA to ensure the authenticity and integrity of prescription drugs that are imported.

True danger or scare tactics?

Neither Dr. Farr nor MacLean had heard of anyone dying from imported Canadian drugs. But that might be because there's no system for tracking this information, said FDA spokeswoman Crystal Rice. The FDA believes that most problems with Canadian drugs show up as adverse effects in the patient. The doctor isn't aware that the medication is from a foreign country, assumes the drug isn't working, and therefore doesn't report the issue.

The pharmaceutical industry, like the FDA, often issues warnings to consumers about foreign drugs.

A spokeswoman for the Pharmaceutical Research and Manufacturers of America pointed out a news report about a pharmacy in Ontario that was caught selling fake heart medication in 2005. The local coroner was unable to determine if the phony medicine had a role in four deaths, according to local media reports.

The FDA has many confirmed cases of counterfeit and substandard drugs from foreign sources that have no active ingredient, too much or too little active ingredient, the wrong active ingredient, or evidence that the drug has been stored or handled improperly. The agency doesn't have the resources to certify the safety of prescription drugs in other countries, Rice said.

The importation language originated in an amendment offered by Rep. Jo Ann Emerson (R, Mo.), who has championed the issue in recent years. Sen. David Vitter (R, La.) successfully introduced similar language into the Senate Homeland Security Appropriations bill over the summer. Emerson hailed the provision as an important victory for patients.

"There is a gross inequity between the prices charged by name-brand drug companies in the U.S. and the prices charged in Canada," Emerson wrote in a press release.

Pharmaceutical companies have basically sunk to the rhetoric of telling Americans that their products are not safe unless they are really expensive, Emerson wrote.

Dr. Farr had more reservations about the cost of American drugs than the safety of Canadian drugs. "As patient advocates, we've certainly got to consider what's in our patients' best interests," he said.

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ADDITIONAL INFORMATION

Drug importation policy

A provision in the recently passed Homeland Security Appropriations bill would:

  • Prohibit U.S. Customs and Border Protection from seizing 90-day supplies of noncontrolled, Food and Drug Administration-approved prescription drugs brought into the country from Canada.
  • Bar importation in this manner from countries other than Canada.
  • Prohibit prescription drugs purchased from outside the United States via the Internet or mail order.

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Illinois governor defends state's drug import program; some question legality

While the congressional lawmakers debated allowing importation from Canada, Illinois Gov. Rod Blagojevich was fighting criticism of his state program. The Illinois auditor general called I-SaveRx "illegal."

Blagojevich is expanding the program to include state employees and dependents, he wrote in a Sept. 19. letter to the Food and Drug Administration. No governor wants to read an audit declaring a state program in violation of federal law, he wrote.

"But when the choice is helping people afford the medicine they need or incurring audit findings, there's really no choice," Blagojevich wrote.

Illinois launched I-SaveRx in October 2004 to allow consumers to buy discounted prescription drugs from foreign pharmacies, according to Auditor General William G. Holland's audit, released in September.

The program facilitated 17,575 purchases from 28 licensed pharmacies in Canada, the United Kingdom, Australia and New Zealand during its first 19 months. Three-quarters of I-SaveRx's 4,954 participants lived in Illinois. The others lived in Kansas, Missouri, Vermont and Wisconsin.

According to the audit, I-SaveRx:

  • Violated the federal Food, Drug and Cosmetic Act by importing prescription drugs into the United States.
  • May have violated the Illinois Pharmacy Practice Act by using pharmacists not licensed in Illinois.
  • Required 521 state employees to provide 5,600 hours of time at a cost of $488,000, although 26 employees were paid from federal funds.

However, Blagojevich wrote, the important thing is that I-SaveRx is allowing people to buy safe, affordable drugs up to 70% cheaper than in the United States. The FDA has inspected 1% of the drugs imported through the program and has yet to find fault with the medications, he added.

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External links

Food and Drug Administration on importing prescription drugs (link)

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