Food and Drug Administration Commissioner Mark McClellan talks to Susan Dentzer about the risks of buying pharmaceuticals from Canadian Internet pharmacies and the challenges of trying to prevent unsafe drugs from reaching U.S. consumers.

The NewsHour Health Unit is funded by a grant from The Henry J. Kaiser Family Foundation.

SUSAN DENTZER: [Illinois] Governor Blagojevich has asked for this pilot project to be approved to experiment with importation of drugs on the behalf of Illinois public employees. What's been the FDA's response and [the Department of Health and Human Services'] response so far?

MARK McCLELLAN: The law is very clear that unapproved imports cannot come into this country unless we can certify that they are safe and effective -- unless we can assure they're safe and effective. And for drugs that are legally produced and available to Americans, there is a comprehensive set of federal and state regulatory systems to make sure those products are safe and effective; that they're manufactured properly, they're stored properly, that they're sent to patients properly, the patients get the right information about how to use the drugs effectively. None of those steps are in place for unapproved medicines that enter the country outside of the law that Congress has given us. So there is no authority to do that under current law.

SUSAN DENTZER: So the answer so far to the governor is --

MARK McCLELLAN: The answer is that's illegal, but let's work together on safe and effective ways to lower drug costs for the citizens of Illinois. There are many programs that have been proven to work in other states, such as making generic drugs much more widely available that can help lower costs without compromising safety.

For example, on Governor Blagojevich's list, 12 of the 90 drugs have generic versions available in the United States that are not only much cheaper than the brand name version, they're much cheaper than the Canadian generic versions as well. That could easily help the state get 5 or 10 percent or more savings than they've been able to project with their importation scheme, which is not legal and is unproven.

SUSAN DENTZER: But the answer, purely and simply, on importation is --

MARK McCLELLAN: We don't have the authority under the law that Congress has given us.

SUSAN DENTZER: If you really had to boil it down to a nutshell, why is importation a bad idea?

MARK McCLELLAN: Importation is unsafe. There are no assurances of safety for drugs. It goes outside of our 60-year tradition of making sure that people are getting the product that they think they're getting, and it's going to work as intended. There is no way for people on their own to assure that a drug really is legitimate, that it's coming from a legitimate site, and it's in fact going to be a safe and effective product. That's not a good standard for medicines in this country.

Americans shouldn't be settling for just safety or just affordability. We need to keep working on policies to get them both.

SUSAN DENTZER: The newly enacted Medicare reform law requires the government now to undertake a study that has to be completed by December. First of all, if you could say that to me, and then tell me what you're doing to carry out that study.

MARK McCLELLAN: Under the new Medicare law, Congress has asked us to address a number of important questions about drug importation. First, can it be done safely and effectively, and if so, how, and second, what are the likely consequences going to be for Americans? Will it really help get their drug prices down? And we take that responsibility that Congress has given us for the study very seriously.

We intend to solicit comments from the public about how to address the safety problems, and we intend to look carefully at steps that we can take, what additional authorities we might need, what additional resources we might need to address these safety concerns, to provide an assurance that the drugs coming in this country are safe and effective.

SUSAN DENTZER: What is the likelihood that at the end of the process the FDA or HSS will conclude that it is safe to import drugs?

MARK McCLELLAN: Well, we are taking the study very seriously. In other cases where Congress has come together and asked us to look seriously at an issue, we've found a way to approach it. For example, just a year ago, Congress passed new legislation to give us more authority and more resources to assure the safety of foods imported into this country. We have now new authorities to make sure that foods, before they come into the country, must be preannounced to us so that we can go and target our inspection resources effectively, and we've got about $100 million in new resources per year to back up those safety steps.

For the highest risk foods such as the meats that the U.S. Department of Agriculture regulates, they have the authority and the resources to actually send people in to foreign plants and make sure that they're in compliance, and make sure that the the meat products are transmitted appropriately.

So there are precedents for looking at the kinds of authorities that are needed to assure safety and effectiveness. The one thing that I know will not work, though, is simply to declare products that have not been shown to be safe and effective, to be legal and expect that that's going to make them safe. It won't.

We need to take more aggressive steps to make sure that we can address the safety and effectiveness concerns, and we intend to figure out exactly what's necessary through the study.

SUSAN DENTZER: Governor Blagojevich and other proponents of importation say if the FDA is so concerned that imports of drugs are not going to be safe, why isn't it taking steps to cut off the drugs that individuals are importing now.

MARK McCLELLAN: We are taking steps. We have only limited authorities and limited resources at the FDA, and we have to find the most effective ways to use them. That's why we've taken steps to enforce the law against companies that are seeking to profit by putting people at risk through importing unapproved drugs, and we have taken legal actions that have been backed up by court findings, where the judge reviewed the facts of the case and concluded that these drugs coming in really are unsafe, and it really is a risk for Americans to be buying drugs from someone who does not have any professional training and cannot provide any assurances about the safety of the medicines.

There are a number of cases like that underway right now that the FDA is pursuing. Our highest priority is going after those who would profit by putting Americans at risk through medicines that are not shipped properly, medicines that are not labeled properly, medicines that are not dispensed properly.

SUSAN DENTZER: It's become clear to us in the course of reporting this piece that a regulatory gap exists in the cross-border pharmacy trade. Would you agree with that statement?

MARK McCLELLAN: I do. There's an important regulatory gap. I think the Canadians have a very effective system for making sure that the drugs that they provide are safe for Canadians. So when you walk into a drugstore in Canada, just like when you walk into a drugstore in the United States, you can be extremely confident that the product that you're going to get will work as it's labeled to work. It's going to be safe and effective.

When you buy across borders, when you buy outside the regulatory system, there are real problems. The Canadian system was not set up to support the safety and effectiveness regulation of drugs that are sent out by companies that serve mainly, if not entirely, Americans. There are many Web sites that exist today that are masquerading as legitimate sites that are providing drugs from perhaps even other countries.

Those kinds of situations are not contemplated or not dealt with effectively under our existing regulatory systems in either the United States or Canada.

SUSAN DENTZER: The attitude of the Canadian government seems to be this is the United States' problem. This is not our problem.

MARK McCLELLAN: Well, they do regard it as mainly a U.S. problem. They've made that clear to me when we've contacted them about a number of these safety issues. For example, when drugs are recalled in Canada, there is no reliable mechanism in place to let Americans know about those recalls; or when we see dangerous products, controlled substances, risky drugs being purchased without proper oversight; or when we see examples of shipping problems or storage condition problems.

And we will keep trying to work with the Canadians to get their help in addressing these safety issues. Our problem is that we don't have any regulatory authorities over these Internet operations operating outside of the United States.

And so I am hopeful that we can work the Canadians to address these safety concerns, but right now they are real and prevalent safety concerns that put people at risk when they buy these products over the Internet.

SUSAN DENTZER: You just sent a letter to your equivalent in Canada, Diane Gorman. What did that letter say?

MARK McCLELLAN: That letter outlined some of our latest findings about real evidence of safety problems when it comes to buying drugs from purported Canadian pharmacies over the Internet. We found a lot of examples in products that we've intercepted at the border of controlled substances, of improperly labeled drugs, improperly stored drugs and the like, that could put patients at risk, and we've sent information to our Canadian counterparts about each of these types of cases.

Most recently we heard from the State of Minnesota where they had sent some of their pharmacy regulators on a voluntary visit to some Canadian Internet pharmacies, and mind you, this is not a regulatory oversight activity. This was a preannounced, voluntary visit where the pharmacies knew that they were coming, and so they had every opportunity to prepare to address any safety concerns that might be there.

They found widespread evidence in most of these pharmacies of noncompliance with Minnesota and federal regulations when it comes to drug safety; problems like storing and sending the wrong amounts of medications, not having good labeling information, not having proper refrigeration for drugs that needed to be refrigerated; having faxes filled for even controlled substances without making sure that the prescription was legitimate -- all of these are real safety concerns that we hope the Canadian government will take steps to address.

In the meantime, with such safety concerns so widespread in these Canadian pharmacies, it really is a buyer beware situation when people buy from an Internet site.

SUSAN DENTZER: The response from the proponents of importation has been you could find the same set of infractions at American pharmacies. This is nothing specifically to do with Canada.

MARK McCLELLAN: And the difference is in American pharmacies we don't wait for preannounced requests from the pharmacy to come see us. We take our authorities and responsibilities for assuring drug safety very seriously, so if there is a pharmacy out of compliance, we will work with state officials to go in and do something about it. That pharmacy will not be allowed to continue to operate, will not be allowed to continue making a profit at patient's expense on an ongoing basis when they are clearly out of compliance with state and federal laws.

SUSAN DENTZER: What are you suggesting that Diane Gorman and others that help Canada do about this?

MARK McCLELLAN: Well, it's a difficult problem for Health Canada because they have a primary responsibility for assuring the safety of drugs for Canadians, and these Internet pharmacies primarily serve Americans, if not entirely serve Americans, and it's a lot of added volume and a whole different type of operation in addition to the usual Canadian pharmacies.

So we are trying to do what we can to let them know when we see safety problems, and we've seen a lot of them, and we hope that they will be able to use their authorities to take steps to help make sure that these pharmacies operate safely.

In the meantime, however, we still are seeing lots of evidence of unsafe drugs coming into this nation.

SUSAN DENTZER: Let's talk about the background issue here, which is disparities in pharmaceutical prices. Why do these large global disparities exist?

MARK McCLELLAN: Well, it's a big problem for Americans, and it is an unfair situation. The United States, in most cases, does not regulate the price of prescription drugs. We don't have the government out there trying to drive the price down to the cost of making -- making available a few more pills. We pay for most of the costs worldwide of developing new medicines, and that's a very big cost today, by many estimates over a billion dollars for bringing a new drug to the market. And I don't think it's fair, and I don't think many Americans think it's fair that the U.S. should shoulder the burden of those costs when drug costs and medical costs generally are getting to be so expensive and so hard for millions of Americans to afford.

SUSAN DENTZER: You've suggested that it's time to revisit the situation. What specifically do you propose be done?

MARK McCLELLAN: Well, I had first proposed that we try to work together to solve the problem of affordable drugs worldwide because drugs, when they are developed, should be available to people everywhere in the world that can benefit from them. It doesn't matter whether it's in the United States where we're one of the wealthiest countries in the world, or in some of the least developed countries of sub-Saharan Africa. If the medicines work, we need to find ways to get them to the public that can benefit.

And I have seen some positive steps in this direction over the past year. For example, there was a trade agreement last year to make available medicines at a very low cost in developing nations that are facing urgent public health problems, and they just simply cannot afford to pay high prices for medicines.

Along with that agreement, the developed countries of the world went along with keeping those medicines intended for sub-Saharan Africa out of their own markets because they know that everyone can't pay just the costs of making a few pills and keeping these medicines available.
So there ought to be some ways that we can build on that effort to work together to make medicines more affordable, and I think this can be done without raising the costs of dr