The Montgomery County Council is considering a program that probably would involve importing prescription drugs from Canada for county employees and retirees. In spite of the disapproval of the U.S. Food and Drug Administration, Montgomery would join several state and local governments in facilitating the importation of such drugs from Canada, where government regulations keep prices down. FDA Associate Commissioner William K. Hubbard spoke with staff writer Cameron W. Barr.
Q Considering that the FDA is headquartered in Montgomery County, do you feel provoked that the County Council is contemplating a drug-import measure that you have said is illegal?
A I think it's emblematic of the power of this issue that our own home county would be considering such a step. . . .
It's clear that public officials around the country are trying to find answers at the local level for the high cost of drugs, and importing foreign drugs is one area that is a growing concern.
Why has the FDA so far refrained from going to court to prevent state and local governments from adopting drug-importation plans or directing consumers to pharmacies in Canada?
We've actively gone to court against commercial operations importing these drugs. We've attempted to reason with public officials . . . and many states and cities and counties that we have talked to have declined to move forward with an importation program after talking with us. Others, however, clearly are moving forward. . . . It may some day come down to legal action, where FDA has to ask a judge to referee this thing.
Would you rule out taking criminal action against a local government?
I wouldn't rule it out. FDA has a range of options for enforcing its law, both civil and criminal, and we've made that point.
Can you point to a specific instance where someone in the U.S. has been harmed as a result of purchasing a prescription drug from a Canadian pharmacy?
Yes, there are small numbers of specific examples like that. However, the system doesn't track them well because these drugs aren't supposed to be here and therefore there's not a monitoring system for them. But, for instance, a lady in Oregon ordered a drug from a Canadian pharmacy for her breast cancer, a drug called . . . tamoxifen, and received something else. She continued to take this bad drug, and her cancer continued to grow. There are also some examples of people that got bad insulin. But again, those numbers are low, largely, we believe, because people are not telling their doctor they're buying these drugs and they're not recognizing problems that may be occurring.
Have you tested drugs obtained from Canadian pharmacies and determined that they were not what they were supposed to be?
Yes. We've actually done two things in the way of testing. We've tested some drugs that were allegedly from Canada, in which the seller was essentially lying about their source, which is one of our concerns, that people are led to Canadian sources that aren't really Canadian. . . . We've tested some of those drugs and found them to be either ineffective or overpotent, superpotent. And then we've also examined actual Canadian shipments that we know came from Canada and have found problems there as well.
. . . There's been all too often drugs from Canada that have been sent to Americans that require refrigeration, and they've not been properly refrigerated. . . . Many people are buying these Canadian drugs and are perfectly happy with them, and we're not suggesting that all Canadian drugs are a problem. . . . If I were in Canada and got sick and went to a local licensed drugstore, I'd be relatively confident I was getting a good drug.