On the Record: FDA on Rx Imports

Tensions are rising between a growing number of states that are helping citizens import cheaper prescription drugs from Canada and the federal government, which maintains that importing drugs from abroad is dangerous and illegal.

Stateline.org spoke with William Hubbard, one of the Bush administration’s chief policy officials on drug imports, about the latest action in the states, including: Illinois’ plans to expand importation beyond Canada to Ireland and the United Kingdom, the U.S. Customs Service’s recent seizure of a prescription drug shipment to a consumer group in Minnesota, Oregon’s wish to license foreign pharmacies, Minnesota’s waiver of co-payments for state employees who order medicine from Canada, and Vermont’s lawsuit asking court permission to import drugs.

Illinois joins Minnesota, North Dakota, New Hampshire and Wisconsin in actively defying the federal ban on drug importation by setting up Web sites to help citizens buy less expensive prescription medicine from Canada. Iowa Gov. Tom Vilsack (D), who’d requested federal approval of a pilot importation program in the Hawkeye State, asked state Attorney General Tom Miller Aug. 25, to explore joining Vermont’s lawsuit.

Hubbard, associate commissioner of the U.S. Food and Drug Administration, said that the administration may be forced to take states to court, but that there is no time frame for legal action. He said the seizure of a shipment of foreign drugs headed to a Minnesota consumer group isn’t a sign that Bush officials are pursuing a new strategy of targeting drug shipments from Canada for seizure.

Legalizing drug imports is the focus of a bi-partisan push on Capitol Hill, while the issue divides the presidential candidates. Democratic presidential nominee Sen. John Kerry of Massachusetts favors allowing importation, and President Bush is holding the line on his administration’s position against it.

Following are excerpts from the Aug. 20, 2004, telephone interview:

Stateline.org: Looking at Illinois Gov. Blagojevich’s (D)proposal to extend importation not just from Canada, but also to other countries in Europe, what’s your reaction to that?

William Hubbard: We’re very concerned about it. We’re afraid that it could put Illinois citizens at risk because they would obviously be given unregulated drugs that are outside our jurisdiction, so FDA can’t vouch for them. I’ve just talked to the Irish; they won’t vouch for them. So we’re afraid that (Blagojevich) is basically saying to citizens, Buy these foreign drugs that no one is going to take responsibility for.’

Stateline.org: Is this going a step further than what other states have done?

Hubbard: It appears to be an aggressive expansion of what Minnesota, Wisconsin and others have done, who have only put up Web sites. … It appears that (Illinois) is taking another step.

Stateline.org: Is FDA going to take any legal action against Illinois?

Hubbard: We’ll certainly be responding to the governor. Whether we would go further is unclear at this point. … (Blagojevich’s) report is 84 pages long, and we’re still trying to fully understand it. But at a minimum, we will be giving him our reaction to his program.

Stateline.org: In the past you’ve sent letters to the governors of Minnesota and Wisconsin expressing FDA’s views about importation. … Why haven’t you taken any legal action so far?

Hubbard: We’ve put our energy thus far into taking legal action against commercial operations who sell drugs. We’ve refrained from going to court against any fellow public official. We’ve focused our efforts on making sure they truly understand the safety and legal concerns we have. In many cases, I think cities and states have understood that and not proceeded. But there is clearly a mounting body of states that are moving ahead, and at some point we may have to go to a federal judge to referee this matter and get a ruling on the legality. We think we would win fairly easily. We think our law is very old and very well-established and very clear.

Stateline.org: Are the states’ current actions illegal?

Hubbard: Certainly the drugs that are imported are illegal, but whether the state actions are illegal is a decision we haven’t reached, but we are certainly looking at that.

Stateline.org: A recent shipment of drugs from Canada to the Minnesota Senior Federation (a consumer group) was seized by U.S. customs officials in Miami. Has that happened before to any shipments from Canada going to state programs?

Hubbard: These were drugs from a Canadian pharmacy we’re familiar with called CanadaRx, and they’d been shipping (medicines) from their pharmacy in Hamilton, Ontario, for several months, and we had not been blocking those sales, even though the drugs are technically illegal.

But all of a sudden a shipment of 439 packages arrived in Miami from the Bahamas, and the customs officials asked us to take a special look at them because of their unusual origin. We’re examining them now, and we’re finding that they’re not drugs that really should be sold here, the generic versions are available here in many cases. They came through the Bahamas, therefore avoiding Canadian regulation, so it undercuts the very argument these pharmacies often make, which is while they’re not regulated by the FDA, they’re regulated by the Canadian FDA.

Stateline.org: Has FDA told customs officials to flag prescription drug shipments?

Hubbard: Not particularly. Customs flagged this for us because they saw the return address. This was a big shipment that arrived by air freight and they basically said, Look, we’ve not been giving special attention to these CanadaRx shipments, but this one is unusual because it came from the Bahamas. So please, FDA, take a look at this.’ So that’s what we’re doing.

Stateline.org: Have you been targeting prescription drug shipments from Canada?

Hubbard: No, this is not a special effort and nothing that we’ve asked Customs to do. But obviously once Customs flags a problematic shipment it’s our responsibility to look at it.

Stateline.org: Some state officials I’ve spoken with have said FDA doesn’t have the ability to control the borders and check every drug shipment coming into the country.

Hubbard: That’s absolutely true. We’ve been saying that in our testimony elsewhere. There are 4 (million) or 5 million of these packages coming in a year. We only have 30 inspectors at the mail facilities. You can do the math very easily that we can’t begin to process all these little drug packages. The vast, vast majority do come to the patient unexamined by FDA, which is in itself a public health problem.

Stateline.org: So going forward, what does FDA plan to do?

Hubbard: There are several things under way. Congress, first of all, is considering legislation to legalize these drugs. Secondly, Congress ordered the Department of Health and Human Services to do a study, which the surgeon general is now conducting, to see whether these drugs can be safely imported. We’re continuing to try to educate both the public and public officials about the risk here, and we have prosecutions under way against commercial operations. So there’s a lot of activity. It’s uncertain whether there will be a firm resolution of this issue this year.

Stateline.org: Some public officials have accused FDA of using the safety issue as a scare tactic. What’s your reaction to that?

Hubbard: Well, I think we’re pointing out the facts. We open up these packages. We’ve noted a lot of poor-quality drugs. We have tried to say to people, honestly, If you buy these drugs, they’re unregulated. We cannot vouch for them.’ We say to people, If you buy a drug at your corner drug store, FDA will stand behind that drug. And you have virtually 100 percent assurance that you get a regulated, well-made drug whose production was overseen by the FDA and that was dispensed by a licensed pharmacy. When you buy these foreign drugs, you get none of that. You’ve gone around a regulatory system that exists for your protection.’

The potential numbers are so vast. Imagine that only 1 percent of Americans was harmed by these drugs, you’d have 2 million injuries. If only one-tenth of 1 percent, you’d still have 200,000 injuries. Well, 200,000 injuries from a given product would be catastrophic to us. We expect a much higher level of safety than that. We fear that these public officials are willing to accept that risk for cheaper drugs. … It’s a consumer buyer-beware environment in which people are buying these drugs.

Stateline.org: You said it’s not likely the importation issue will be resolved this year. What sort of impact do you think this issue is having on the election?

Hubbard: I couldn’t comment on that. Obviously, (Massachusetts Sen. John) Kerry has taken a position on it. President Bush has spoken for the first time on it.

Stateline.org: Some news reports said that President Bush is perhaps softening his position on this?

Hubbard: I saw his statement. I think it’s very consistent with what FDA is saying, what we’ve been saying all along, that while the drugs out there in these other countries are cheaper, there’s also no way to ensure the safety. That’s essentially what the president has said. You can’t figure out whether to bring these drugs in unless you know that it can be done safely.

Stateline.org: As far as any legal action against the states, is there a time frame?

Hubbard: No, there’s no specific time frame. I mean, we were sued (this month) by Vermont. So in that sense, there’s a time frame on a lawsuit where the state is suing us.

Stateline.org: What’s your reaction to the Vermont lawsuit?

Hubbard: I would like to think that our law is so clear and well-established that we would always win. But there’s a difference between being confident in your legal theory and actually picking a fight with a state or a city and stepping outside of a more cooperative role and into a more hostile role, and I think we’ve tried to avoid that. It may come down to that, where we have to go to a judge, and say, Look, you’ve got a clash here between these governors wanting to find cheaper drugs and a federal law that says they shouldn’t been imported.’

Stateline.org: And now the governor of Oregon (Democrat Ted Kulongoski) has just come out with a proposal?

Hubbard: He’s got a slightly different twist. He’s petitioned us to allow the Oregon Board of Pharmacy to license some foreign pharmacies. So we’ll be looking at that and responding to him.

Fortunately, (Kulongoski) and the governor of Vermont (Republican Jim Douglas) are staying within the legal system. They’re coming to us and having the discussions, and in the case of Vermont, they petitioned us and waited for our response and now they’ve gone to a judge. They’re staying within the legal system. They’re saying, We’re not going to put people at risk until we’ve exhausted legal remedies.’ We like to think that’s where people ought to be, instead of willy-nilly just going out and buying drugs from foreign countries.

It’s very interesting, in the case of the Illinois program, the Irish government is saying, No … these drugs will be illegal if they’re sold here. We don’t agree with this. You didn’t talk to us before you did this.’

I think that’s a real flaw in (Illinois’) thinking that they would pick a country without even having talked to the government of that country. The (Irish) government is apparently somewhat upset about all this. When I met with the governor’s people, we said, Well make sure you go to these countries and talk to them about this.’ But it appears they only talked to some European Union official and never talked to the Irish officials. I view that as a major weakness in their thinking. They didn’t think it through. Anytime you don’t think something through that puts people at risk, you have real doubts about whether they should have done it.

Stateline.org: What about Minnesota Gov. Tim Pawlenty (R)? The state has expanded from just a Web site and begun waiving co-payments for state employees that are ordering medicine from Canada.

Hubbard: I’m not aware of that. Is that true?

Stateline.org: According to Kevin Goodno, (Commissioner of the Minnesota Department of Human Services.)

Hubbard: That’s news to me, actually. We’ve had communications with Mr. Goodno and the governor, and Mr. Goodno recently sent us a proposal to inspect these foreign pharmacies that we’re going to be working with them on, under the auspices of U.S. Sen. Norm Coleman (R). So there’s a communication channel there with Minnesota that’s open and active. But I’m not aware of the co-pay issue. I’ll have to examine that. They have not notified us of that, I can tell you that. I’m not shocked, but I would have thought they would have told us.