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YES
The reimportation legislation recently passed by the House of Representatives will leave America's patients in grave danger. The bill would not include the same safeguards for reimported drugs that we currently have on prescription drags in the United States. If drugs are allowed to bypass this system, Americans could no longer be assured that the medications they take to make them better aren't actually harming them.
The Food and Drug Administration has made it clear that it currently lacks the resources to fully investigate and stop reimportation of adulterated, misbranded, and unapproved drugs into the United States. Once the drug is outside the United States, the FDA can't guarantee the quality or safety of a drug reimported back into the country. If the current legislation were approved, a frightening and unintended result could be the import of expired, subpotent, contaminated, or counterfeit drugs--not to mention wrong or contraindicated product, incorrect doses, or medication unaccompanied by adequate directions for use.
The legislation also allows patients to import the drugs by any means possible, including the Internet. Forget the news images of seniors taking the bus to Canada to purchase prescription drugs, and replace that with one of drugs arriving in the mail after purchase over the Internet from an unknown entity. The federal government is already straining to monitor the tens of thousands of drugs mailed into this country every day. Patients with just a computer and a credit card to guide them may be lulled into a false sense of security by Internet sites that claim to be based in Canada, but are really based elsewhere.
Drug counterfeiting is a growing problem everywhere, but luckily it's still a small problem here, compared with many other parts of the world. FDA counterfeit drug investigations have increased to over 20 per year since 2000, compared with only about 5 a year in the late 1990s. Compare that to Nigeria where up to 80,000 children were given fake meningitis vaccines or Southeast Asia where a study found that one-third of drugs contain no active ingredient, according to a recent National Public Radio report. These are the kinds of troubles we will be importing.
As prescription drugs play an increasingly larger role in treating patients, the ability of patients to purchase these drugs remains a crucial challenge. Patients should not have to choose between food and medications. We need a real solution to this growing problem, not one that has potential for devastating and unintended consequences.
Dr. Donald J. Palmisano is president of the American Medical Association.