FDA OFFICIAL: This is essentially from the same supplier in India.
SUSAN DENTZER: Illegal drug importation is fast becoming one of federal health officials' worst nightmares. This inspection facility at New York's Kennedy Airport shows why.
FDA OFFICIAL: This package, from Brazil, this looks like more birth control pills and other items.
SUSAN DENTZER: The facility is operated by the U.S. Postal Service, and it's where mail from abroad is examined by various government agencies. If the mail contains prescription drugs, as these packages do, it's turned over to the Food and Drug Administration.
The FDA has told congressional staff that more than 10 million parcels containing prescription drugs now enter the country each year. FDA Consumer Safety Officer John Moore said the agency keeps many of the packages and warns the recipients.
JOHN MOORE: We will notify the recipients that they appear to be in violation of the FD&C Act under regulations concerning these pharmaceuticals. They will be provided an opportunity to respond to that, why they should have it, and ultimately these will be refused and they will be sent back to the senders.
SUSAN DENTZER: Moore says the U.S. taxpayer pays the bill for the return shipping. But the understaffed FDA only vets a fraction of these packages; it allows most other packages containing drugs to go on to their destination. Agency officials increasingly worry about what might be getting through this erratic dragnet. They showed us one example: Human growth hormone from China, to be given to patients by injection. It's often used as an anti-aging treatment, although it's unapproved for that purpose in the U.S.
JOHN MOORE: We see quite a bit of this coming in from the People's Republic of China. And there is no English language labeling on it, instructions or anything like that. In addition to that...
SUSAN DENTZER: And it's supposed to be refrigerated.
JOHN MOORE: It is.
SUSAN DENTZER: What happens to a drug like that if it's not kept cold?
JOHN MOORE: I'm not a pharmacist. It will start to degrade the drug if there is any bacteria inside there -- it's for injection -- the bacteria could grow.
SUSAN DENTZER: Outgoing FDA Commissioner Mark McClellan, who was confirmed today as the new administrator of Medicare and Medicaid, says the bottom line on these imports is clear.
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.
SUSAN DENTZER: But at a recent Capitol Hill conference on importation, congressional proponents from both parties criticize the FDA. They called the agency's safety concerns a smokescreen to protect the pharmaceutical companies' interests.
REP. GIL GUTKNECKT: We know how many people have died from taking drugs from Canada, legal prescription drugs. It's a nice round number. It's easy to remember. It's zero.
SUSAN DENTZER: Democratic Sen. Byron Dorgan of North Dakota temporarily blocked McClellan's nomination over the importation issue.
SEN. BYRON DORGAN: Why should the American consumer be charged nearly double for the same pill put in the same bottle manufactured by the same company in an FDA-approved plant? The answer is the American consumer is being cheated and the FDA is driving the getaway car.
SUSAN DENTZER: Safety concerns are among the most controversial issues in the current importation debate. Lining up with the FDA and pharmaceutical companies are state pharmacy regulators, as well as many physician and pharmacy groups. On the other side, are thousands of import consumer Americans as well as some governors and lawmakers here in congress. They say importation could be done safely, restricted to drugs approved for use in the U.S. and allow only if the drugs came through legal channel from certain countries.
That's the idea behind a new Minnesota state Web site, Minnesotarxconnect.com. It points state residents looking for cheaper drugs to two Canadian pharmacies, one in Calgary and one in Vancouver. Tim Pawlenty is Minnesota's Republican governor.
GOV. TIM PAWLENTY: It is true that there are some shady characters that operate on the Internet with respect to prescription medicines. But that's not what we're talking about here today and that's not what we're proposing. We're talking about using government to enter into a relationship with established, safe, credible reputable Canadian pharmacies and, as applied to those pharmacies, there are no safety concerns.
SUSAN DENTZER: The FDA has sharply criticized Minnesota's Web site. But the agency says it's even more worried about the broader importation plans proposed by many governors and members of Congress. If those plans were adopted, says the FDA's Tom McGinnis, there'd be no way to head off an influx of unsafe drugs.
TOM McGINNIS: One of the things we believe, if importation was allowed, that there would not be enough product available in Canada for all the states that would want to bring this in. There would be shortages of product occurring in Canada, and that's where we see counterfeiters coming in to try to meet that demand for product to come back into the United States.
SUSAN DENTZER: Pharmaceutical company executives like Pfizer's Hank McKinnell echo that concern.
HANK McKINNELL: The World Health Organization has estimated 20 percent of prescription medicines sold around the world are counterfeit. In some countries, it's as high as 40 percent. Here in the United States, the incidents of counterfeit medicine is very low, thanks to laws that were enacted several decades ago that have been enforced by the FDA very effectively. But, quite frankly, those laws are now being overwhelmed by Internet pharmacies and shipments of medicines from abroad.
SUSAN DENTZER: Pfizer should know. Thousands of counterfeit copies of its anti-impotence drug Viagra abound. In 2002, counterfeit versions of its best-selling drug Lipitor were produced in Costa Rica, brought to the U.S. and then sold to consumers in several states.
The FDA says many counterfeit drugs are sold over Web sites like this one, called value prescriptions. Despite its Canadian maple leaf symbol, the service was actually shipping drugs from India.
SUSAN DENTZER: Officials of Health Canada, the federal health agency, refused our request for an interview about drugs coming from or through Canada. But a spokesperson told us the department is closely watching the growing number of Canadian Internet pharmacies catering to Americans. There are at least 64 of them alone in the largely rural Canadian province of Manitoba. One is rxnorth.com, it was founded in 2000 by pharmacists Andrew Strempler, 29, and Mark Rzepka, 28.
ANDREW STREMPLER: Sales this year estimated will probably be 120 million U.S. dollars. Last year, 2003, was approximately $80 million U.S.
MARK RZEPKA: Not only is it benefiting the American consumer, but it's benefiting our local economy, people who live right here in Manitoba, and everyone at large.
SUSAN DENTZER: Others, like Winnipeg pharmacist Michele Fontaine, disagree. She says the Internet pharmacies have contributed to drug shortages, affecting pharmacies like hers that cater to Canadians.
MICHELE FONTAINE: They've gone to order medication and there's none. They can't get it because it's been pulled through another means, perhaps through an illegal underground wholesale network, and being shipped to the American patients.
SUSAN DENTZER: New evidence suggests that some of the Canadian Internet pharmacies are not operating safely. Before Minnesota state authorities set up that state's new Web site, they inspected eight Canadian pharmacies and found unsafe practices at six. One of the pharmacies was apparently recycling drugs that had been rejected at the U.S. border and was then reshipping them to other American patients. Canadian regulator told us many of the Internet pharmacies were also flouting or testing limits of other laws and regulations.
This letter from a Manitoba pharmacy offer a $20 credit to a U.S. doctor for each patient referral. De facto kickbacks like this are considered illegal or unethical in most of the U.S. and Canada. What's more, in most of Canada, a prescription can't be dispensed to a U.S. patient unless it's cosigned by a Canadian doctor who has a relationship with that patient. Rxnorth says it typically meets that requirement by shipping the prescriptions to Canadian doctors working outside the country.
MARK RZEPKA: Many of them are located in the United States, actually, but they maintain Canadian licenses, which allow them to facilitate this co-signing.
SUSAN DENTZER: So you could have a prescription co-signed by a Canadian doctor in Malibu, Calif.?
MARK RZEPKA: Absolutely.
SUSAN DENTZER: Does that doctor have a relationship with the patient in Topeka, Kan.?
MARK RZEPKA: Probably not.
MICHELE FONTAINE: There's no continuity of care. A physician hasn't seen the patient. They're relying on another physician's diagnosis. There's a reason pharmacy practice exists, there's a reason that the regulations are in place. And if you're going to go through every back door to get around that, you have to question whether that's in the best interest of the patient.
SUSAN DENTZER: Outgoing FDA Chief McClellan had been named to run a government importation task force. But he was stripped of that post this week under pressure from importation advocates. Even so, he says, legal and regulatory changes will still be needed to deal with the cross-border drug trade.
MARK McCLELLAN: When you buy across borders, when you buy outside the regulatory system, there are real problems. Those kinds of situations are not contemplated or not dealt with effectively under our existing regulatory systems in either the United States or Canada.
REP. GIL GUTKNECKT: We import everything from automobiles to nuclear power rods, and yet somehow we have singled out pharmaceuticals under some form of pharmaceutical exceptionalism.
SUSAN DENTZER: Importations proponents like Gutkneckt now want the task force to discover way to import drugs safely.