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Volume 3, Issue 9
June 15, 2004



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Early this month FDA closed its comment period on one of the most controversial proposals for prescription drugs—legalized prescription drug importation. I hope you had a chance to weigh in.

I also hope you’ll take the chance to read all the comments submitted, especially those from your fellow drug product manufacturers and packagers. The testimony is at times compelling, such as that from John Theriault, vice president, global security, for Pfizer Inc. Theriault recounts the extensive efforts needed to track down counterfeit products that could have originated anywhere in the world.

Another noteworthy comment comes from Giuliani Partners LLC, a consulting firm founded by former New York City mayor Rudolph Giuliani. The firm has been hired by the Pharmaceutical Research and Manufacturers of America (PhRMA) to consider whether importing drugs from Canada into the United States is risky.

The interim findings show that the issue isn’t as clear as many think. Importing drugs from Canada doesn’t necessarily mean that the drugs are manufactured in the United States, then sent to Canada, then reimported back to the United States, as many consumers and advocates appear to assume. It doesn’t even guarantee that the drugs are made in Canada and then imported to the United States. Instead, many of the drugs that are now imported (illegally) from Canada are actually made in other countries, some as far out of FDA’s reach as Pakistan, China, and Thailand. “Non-FDA approved drugs from foreign countries . . . are not at all what they claim to be,” the report finds. “There is significant evidence that patients have received drugs . . . that are past their expiration date, are sub-potent, contain the wrong dose, are contaminated or clearly counterfeited, are not properly stored or shipped (i.e., medicines that require constant refrigeration or others that must be protected from freezing), among other problems.”

Giuliani’s firm also finds that many of the packaging technologies suggested as ways to authenticate drug products are not “foolproof” or “not yet available.” For instance, “electronic track and trace . . . technologies, e.g., using bar coding and radio frequency identification . . . are still very costly.” Also, “counterfeit resistant technologies . . . such as holograms, watermarks, color shifting inks, or fluorescent inks . . . can be easily duplicated and must be changed on a periodic basis.” And “unit-of-use packaging . . .does eliminate the need for some repackaging, [but] there are packaging and cost issues for the manufacturers and some drugs do not lend themselves to such packaging.”

Since the report is a preliminary one, with a conclusion yet to come, it is too soon to say what Giuliani’s position will be. It is safe to say, however, that it already appears markedly different from the stance his predecessor, New York City mayor Michael Bloomberg, took in October 2003. Bloomberg clearly supports legalizing drug imports from Canada.

This is just one interesting snapshot of the debate over legalizing drug importation. Check out the rest, and maybe even add your voice. Even though FDA has stopped fielding comments, Congress has not. And consumers need to hear your side of the story. Can packaging be used to authenticate your products? And should it be used to demonstrate that imports are safe? Or should packaging be used to show that drugs packaged for U.S. consumers are the only ones that should be sought by U.S. consumers, because they best serve U.S. consumers?

 

Daphne Allen

 
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