Washington Editor

WASHINGTON - A majority of Americans who participated in a recent survey said they would oppose reimporting FDA-approved prescription drugs from Canada if they couldn't be sure the drugs were safe.

And while Canada can guarantee a patient that drugs approved under its regulatory system are safe and effective, the government has never officially stated it would be responsible for the safety of prescription drugs exported to the U.S. or any other country. That is, they will not be responsible for drugs manufactured in Canada specifically for the purpose of export.

"Drugs that are manufactured for export must comply with regulations that have been established by the importing country," Ryan Baker, media relations officer at Health Canada, told BioWorld Today. "A drug manufactured in Canada can be sold without having been approved for sale in Canada as an export to the U.S., but only if the manufacturer has obtained authorization to market the drug from the U.S. FDA."

Recent press accounts have erroneously implied that Canada guarantees every truckload of drugs that crosses its borders, which is simply not the case.

Unfortunately, that misunderstanding pops up at a time when senior citizens are loading buses to Canada to purchase lower-priced prescription drugs. Any mention of Canada failing to guarantee a drug could provide fodder for the political side looking to enforce laws that prohibit reimporting prescription drugs.

Most people who oppose reimporting do so on the basis of safety. Even Donna Shalala, former President Clinton's secretary of Health and Human Services, could not support legislation that allowed people to bring drugs in from other countries. Before leaving office in 2001, Shalala refused to implement such a law out of safety fears.

But proposals to reimport keep popping up, and the arguments for and against remain the same.

In a study commissioned by the National Association of Chain Drug Stores (NACDS) in Alexandria, Va., 54 percent of the respondents agreed that importing medications from Canada poses a serious risk because "there is no guarantee that you are getting what you think you are." Furthermore, 77 percent of the people agreed that if reimporting from Canada were illegal, then people shouldn't do it.

Beyond the fact that reimporting is illegal, NACDS, like many other trade organizations, lawmakers and health care providers, is concerned about the quality of the product an unsuspecting patient could end up purchasing online or through a middleman, oftentimes referred to as a "storefront."

"If you look at these storefront operations, basically you waive any rights you have if something goes wrong with the medication that you are receiving from an illegal source, so it absolves them from liability," Crystal Wright, NACDS's vice president for media relations, told BioWorld Today. "We still believe in the law of the land. When you get in the practice of rewriting American prescriptions to fit Canadian orders, the dosings are still different. When you are in the business of playing doctor for yourself and you are taking your American doctor and your American pharmacist out of the equation, there's a lot of risk."

While that may be true, there are a lot of desperate seniors out there.

Trudy Pueppke, who runs a so-called "storefront" in Boulder, Colo., called Rx of Canada, told BioWorld Today of an acquaintance who had a fixed income of $900 per month and a prescription drug bill of $1,100 a month. "I've seen people who couldn't buy food - you just want to give them your billfold to buy something to eat," she said.

Regarding safety, Pueppke said the packaging on drugs from Canada is sealed. "I've never gotten a drug in the U.S. that was sealed like that," she said.

Sen. Byron Dorgan (D-N.D.) introduced legislation to allow pharmacists and drug wholesalers to reimport FDA-approved drugs from Canada. The bill also would give individuals a waiver to reimport prescription drugs from Canada as long as the medicine is for personal use. (See BioWorld Today, March 6, 2003.)

A similar measure was introduced in the House by Reps. Bernard Sanders (I-Vt.), Joseph Crowley (D-N.Y.) and Dan Burton (R-Ind.). (See BioWorld Today, Feb. 18, 2003.)