The FDA Huffs, but Canadian Drugs Are OK

February 20, 2004

This op-ed appeared in New York Newsday Feb. 20.

By: Paul L. Doering
Paul L. Doering is a professor of pharmacy practice at the University of Florida’s College of Pharmacy.

The Food and Drug Administration would have consumers believe they’re taking a huge risk when they send their prescriptions to pharmacies north of the border, where the same drugs cost far less than they do here.

Hogwash. The fact is, drugs purchased through the Canadian health care system are every bit as safe as those available in the United States.

The FDA’s warning is a smokescreen thrown up to conceal the agency’s – and Congress’ – unseemly coziness with the drug industry.

The FDA warns that Canadian drugs may be outdated, subpotent, contaminated or counterfeit. The agency says that Canadian pharmacists might dispense the wrong or a contraindicated product, an incorrect dose, or a medication that isn’t accompanied by adequate directions for use.

But the agency has no justification for its cautions. To the contrary, a recent report by the Congressional Research Service supports the safety of drugs from Canada. It found that medications manufactured and distributed there meet or surpass quality-control guidelines set by the FDA.

According to this report, prepared at the request of Rep. Bernard Sanders (I-Vt.), the two countries regulate prescription drugs in virtually identical ways – from manufacturing and importation to labeling, distribution and sales. The report found that Canada’s pharmaceutical controls mimic those in the United States, with Canada tracking drugs through each distribution step.

The proof is in the pudding. Are people really being hurt by taking prescriptions filled in Canada? When asked to give examples of people who have been harmed, Tom McGinnis, the FDA’s director of pharmacy affairs, said late last year, “We don’t have that. I can’t think of one thing off the top of my head where somebody died or somebody got put in the hospital because of these medications. I just don’t know if there’s anything like that.”

Meanwhile, it’s clear that there are major problems in the drug regulatory arena right here in the United States. People were shocked to learn recently that counterfeit versions of the cholesterol-lowering drug Lipitor were surfacing in large U.S. pharmacies. Other instances of counterfeit drugs entering U.S. commerce have led to further questions about the safety of the drug supply.

The real issue, of course, is not whether the drugs from Canada are safe, but rather, why are they so much cheaper? Canadian pharmacies offer savings that average 35 percent over prices available in the United States, mostly because the Canadian government imposes price controls.

In a free-market society, people’s blood boils at the thought of imposing price controls. But is the health care industry part of a true free-market economy? When purchase decisions are ultimately made by the prescriber without much input from the patient, as is the case here, the drug industry is not a free-market economy.

The FDA’s froth about Canadian drugs are indicators of a much larger problem: the inability of the current administration to lower the outrageous cost of prescription drugs. Viewed through that lens, the FDA’s recent rantings are intended to deflect criticism from Congress’ inability to come up with a meaningful program to reduce the costs of drugs and to conceal its toasty warm relationship with the industry.

Cash-strapped health programs from cities and states around our nation are beginning to embrace the idea of taking their business north. Surely, responsible government officials from around the nation would not thumb their collective noses at the FDA if they felt it would put citizens at risk.

Make no mistake about it: Buying drugs from licensed brick-and-mortar pharmacies in Canada is an altogether different proposition from buying drugs from so-called rogue Web sites. Anytime consumers are offered the opportunity to buy prescription drugs without a prescription, they should be suspicious. It is illegal to do so, and more importantly, it’s a risky proposition. But it’s not the same as getting a properly written prescription filled by a licensed and regulated pharmacy through the mail.

The sound of FDA’s sabers rattling is reverberating from Vermont to Florida and from California to Washington.

I am not sure what the answer is, but it is time we shifted our focus from Canada to Washington – where the real problem lies.