DrugBuyers.Com: Pending Legislation

An AMA opinion piece appearing today:

OPINION

Imported prescriptions: A prudent FDA crackdown
Internet pharmacies and storefront operations that offer offshore prescription drugs to American patients can expect to find themselves in trouble with the FDA.
Editorial. April 28, 2003.

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When an offer seems too good to be true, it very well might be. The Food and Drug Administration is wisely taking this dictum to heart in stepping up enforcement of laws against the importation and sale of medicines from abroad.

And this effort is leading the agency to look especially hard at operations close to home -- businesses that sell Canadian prescription drugs to U.S. consumers via the Internet and storefront operations.

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Here's why. About 10% of Canada's drug market is diverted to the United States. The reason: Price controls there make Canadian-approved drugs more affordable than those approved and marketed here.

That raises some basic problems. These prescription medications are not technically FDA-approved. They offer none of the official public health assurances of quality, purity, efficacy and safety that come with the FDA's imprimatur -- the world's gold standard. And their means of distribution are outside the realm of proper pharmacy licensing. Thus, the FDA considers them a growing public health risk.

In March, the FDA joined forces with pharmacy boards in Arkansas and Oklahoma, issuing a warning to Rx Depot Inc., which processes Canadian prescriptions through storefront operations in Arkansas, Oklahoma and three other states. The FDA told Rx Depot that it considers the company's operations to be "a clear violation of the drug safety laws that protect Americans from unsafe drugs."

The action received praise from the American Medical Association. "We commend the FDA for taking action on this issue to protect public health and safety," said AMA President Yank D. Coble Jr., MD, in a March 24 statement. He added that these prescriptions raise "serious concerns about the lack of physician advice and oversight as well."

Based on information from Rx Depot's Web site and the FDA, here's how the orders are placed and fulfilled. A patient takes his or her prescription to an Rx Depot storefront, or fills out a patient information form from the Internet and faxes it along with the prescription to a store location. The U.S. prescription, along with the patient's credit card information and paperwork, are sent to a Canadian pharmacy. A prescription is then obtained from a medical doctor in Canada. Canadian drugs are then shipped by a pharmacy there, directly to the U.S. consumer.

The FDA takes issues with a number of aspects of this process. They are all detailed in a three-page warning letter dated March 21. The bottom line is that prescription drugs from foreign countries -- even our neighbor to the north -- are not necessarily the same as those approved by the FDA.

They do not have the same assurance of safety. They could be outdated, contaminated, counterfeit or contain too much or too little of the active ingredient. They could be incorrect medications or labeled without proper directions for use. They may look the same. Sometimes they might actually be the same. But there's no guarantee because the chain of accountability is blurred.

Rx Depot disputes the agency's allegations. The company maintains that the medications are safe and that Rx Depot is simply in the business of helping senior citizens gain access to less-costly drugs -- a public service that is, for some people, the only way they can afford needed medication.

It's a notion that has some very powerful backers. Some members of Congress say the FDA is scaring seniors who are trying to get more affordable medicine by turning North.

The most prudent approach, however, must be to ensure safe and effective prescription drugs and to take firm action when Internet pharmacies or storefront operations fall outside the law. Quality assurance and public health protections are critical to both the patients and physicians of America, and something that shouldn't be compromised -- even when shopping for a bargain.

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The older I get the more I