'The rest of the story' on importation
Health Care Op-Ed
By: Peter J. Pitts
5.31.2005
The Baton Rouge Daily World, May 31, 2005
In my former role as associate commissioner at the Food and Drug Administration, I was privileged to travel the country speaking on, writing about and listening to the contentious debate over legalizing prescription drug importation. Frankly, it didn't come as a surprise to me that most of the Americans I've met support the concept of importing prescription medicine from Canada. They're our neighbors. We like them. We trust them. They have ethical medical and business standards comparable to our own. But that's not the honest story of importation. Much like a book that reads well but delivers a disappointing ending, the last few chapters in the importation saga leave much to be desired. The perception that Canada and "importation" are synonyms is just that, a perception, and a dangerous and dishonest one. Importation backers shrewdly market their snake oil as nothing more than legalizing and formalizing what already occurs everyday. They portray a storybook business model where American patients fill prescriptions online and open a brown package a few days later to find safe, inexpensive pills, postmarked Ottawa, Ontario. It's an attractive scenario: attractive, but false. The two most prominent pieces of legislation pending in Congress, one by Sen. David Vitter, a Republican from Louisiana, and another by Byron Dorgan a Democrat from North Dakota, would allow for the importation of prescription drugs into the United States, eventually ending up in your local drugstore from more than 20 foreign countries with names that sound nothing like Canada. They include Lithuania, Latvia, Estonia and South Africa. Drugs that would come to the U.S. from Canadian Internet pharmacies that aren't even legal for sale in Canada! Opening our markets and medicine cabinets to these countries presents significant safety concerns that my former colleagues at the FDA say cannot be adequately assuaged. Admiral Richard Carmona, the U.S. surgeon general, and the U.S. Drug Enforcement Agency agree that importation would endanger Americans by allowing counterfeit, expired, subpotent, superpotent, unregulated medicines into the international pipeline that ends in America-the world's No. 1 retail drug market. The concerns of our public health officials are certainly justified. A recent report, issued by former New York Mayor Rudy Giuliani and his respected partners, found that safety will undoubtedly be compromised if current legislative efforts to broadly legalize importation beyond North America are successful, reporting that 86 to 88 percent of suspected drug parcels examined at various airport-mail facilities in the United States contained non-FDA approved medicines from countries such as Pakistan, Mexico and Brazil among others. But the report raised concerns far beyond just greedy counterfeiters. Giuliani speculates that enemies could use the improved legal access to our drug supplies as a mechanism for terror. He added that it's incredibly ironic to be spending record resources at securing every other type of border while simultaneously considering throwing another wide open. During my tenure at the FDA, we examined over and over the possibility of importing medicines from Canada. Time and time again, we came across the same stumbling block: many drugs imported from Canada are not made in Canada. The FDA cannot, and Canada will not, guarantee how safe they are, under what standards and supervision they were made, or even where they were made in the first place. Regardless what you've heard about "Canadian importation," shipments allowed under both the Dorgan and Vitter bills would come from all over the world, and everyone but the politicians agree that safety will be compromised. As Paul Harvey says, "that's the rest of the story." Peter J. Pitts is a senior fellow for health care studies at the Pacific Research Institute and former Associate Commissioner at the FDA.
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