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Drug reimportation debate is still heating up: any new drug reimportation legislation needs to ensure that reimported drugs are FDA approved.

For Dr. Ronald 1. Blum of Island Falls, Maine, the national debate on drug reimportation is old news.

As a family physician whose practice is just 25 miles from the Canadian border, Dr. Blum said he estimates that at least one in 10 and perhaps as many as one in 3 of his patients get their prescriptions filled in Canada.

The controversy is much hotter for the rest of the country, where prescription drug prices are expected to be a part of this year's election debate.

The Bush administration has formed a task force to consider how drug reimportation could be done safely and what impact it could have on health, medical costs, and the development of new medicines.

The task force, chaired by U.S. Surgeon General Richard H. Carmona, has been holding a series of "listening sessions" in Washington in preparation for making recommendations by the end of the year.

Sen. John F. Kerry (D-Mass.), the presumed Democratic presidential candidate, supports drug reimportation. Sen. Kerry wants to allow individuals, pharmacists, wholesalers, and distributors to reimport FDA-approved prescription drugs from other countries. He also has called on President Bush to approve state pilot programs to help reimport drugs.

And new legislation was introduced in the Senate in April that seeks to legalize imports of FDA-approved drugs from Canada and several other countries.

The legislation (S. 2328), which is being billed as a bipartisan compromise, would allow personal reimportation of a 90-day supply of drugs from Canada. In addition, consumers who travel to European Union countries, Australia, New Zealand, Japan, and Switzerland would be allowed to bring back 90-day supplies of medications. Consumers would be allowed to bring back 14-day supplies of medications from other foreign countries.

The legislation also would legalize commercial importation by pharmacists and drug wholesalers from Canada within 90 days of enactment of the law, and from the European Union countries, Australia, New Zealand, Japan, and Switzerland within a year.

The pharmaceutical industry strongly opposes reimportation.

"This bill undercuts the FDA's ability to protect patients' health and will potentially allow foreign versions of medicines from over 22 countries into the United States--including medicines from places like Latvia, Estonia, and Slovenia," Alan F. Homer, president and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA) said in a statement.

Instead, Americans can get cheaper drugs through the new Medicare prescription drug benefit, through the purchase of generic drugs, and through pharmaceutical industry patient assistance programs, PhRMA said.

To date, reimportation does not have much support within the physician community. The American Medical Association and the American College of Physicians have policies against the practice, citing safety concerns.

"Patient safety must remain the over-riding concern in any discussion on drug reimportation, and patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or in-appropriately labeled," Dr. Donald J. Palmisano, AMA president, said in a statement.

Any new drug reimportation legislation needs to ensure that reimported drugs are FDA approved, he said.

"This is an issue that is very much on the minds of physicians," Dr. Michael O. Fleming, president of the American Academy of Family Physicians, told this newspaper.

AAFP has taken the position that "affordable, quality drugs should be available to our patients who need them," Dr. Fleming said. And it's the responsibility of drug companies and the government to find a way to provide these medicines, he said.

For Dr. Richard Stefanacci, a geriatrician in Philadelphia, when the choice for patients is between going to Canada for the drugs or going without them, the choice is clear.

"Obviously the main reason for anyone choosing Canada is not convenience, it's financial," Dr. Stefanacci said.

Most patients do not consult their physicians before choosing to buy their medications from a Canadian pharmacy. Dr. Stefanacci said he usually learns that his patients are getting their drugs in Canada when he has them bring all their medications to an office visit.

Since most of the drugs patients bring in are still in their FDA-approved packaging, they "look" safe, Dr. Stefanacci said. But he said that just looking at medications and their packaging cannot ensure safety and that's why he said he's pleased to see legislation being introduced in Congress that aims to ensure the quality of reimported medications.

"In general, physicians should be very involved when it comes down to patient compliance," Dr. Stefanacci said. The idea of reimporting drugs from Canada is not inherently unsafe, said Dr. Blum, who is also regional public health medical officer for northern Maine. In the 25 years that he's been practicing, he's never known anyone who has had a problem as a result of Canadian drugs or heard of anyone having a problem.

But that doesn't mean he doesn't have concerns. Dr. Blum said there are now new processes of counterfeiting that weren't a problem in the past.

"The FDA should be helping us scrutinize and supervise the importation rather than just fighting it," he said.


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Title Annotation:Rx; Food & Drug Administration
Author:Schneider, Mary Ellen
Publication:Internal Medicine News
Geographic Code:1USA
Date:Jun 1, 2004
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