Washington Editor

Bipartisan legislation introduced in the Senate this week would punish drug companies that seek to protect and control their products by limiting sales to Canadian wholesalers and pharmacies. The bill, which would allow Americans to purchase FDA-approved drugs from Canada and elsewhere, was co-sponsored by Sen. Trent Lott, a Mississippi Republican who once opposed importing prescription drugs from foreign countries.

While it is currently illegal to import prescription drugs from other countries, the FDA traditionally has looked the other way and failed to take action against the busloads of senior citizens that cross Canadian borders to buy cheaper drugs.

In an effort to prevent their products from being illegally exported into the U.S., a few companies, such as New York-based Pfizer Inc. and London-based GlaxoSmithKline plc, took matters into their own hands last year by limiting shipments to Canadian wholesalers or pharmacies known to sell back into the U.S. Canada does not regulate drugs shipped into the U.S. (See BioWorld Today, Feb. 18, 2003, and Aug. 11, 2003.)

The response to that action by the companies was not pleasant in certain circles on Capitol Hill. For instance, Rep. Bernie Sanders (I-Vt.) said Pfizer's move was a declaration of war against American senior citizens and the chronically ill.

So lawmakers reacted.

Last year in a 243-186 vote, the House approved legislation that would stop companies from limiting sales to foreign wholesalers and pharmacies, referring to those tactics as unfair trade practices. The Senate bill contains similar language. Indeed, on the Senate floor Wednesday, John McCain (R-Ariz.), also a co-sponsor of the bill, charged that "several powerful brand companies are putting profits before patients." He said that type of business is "unacceptable."

Meanwhile, the new Medicare law signed by President Bush in December legalizes importation of prescription drugs if Health and Human Services Secretary Tommy Thompson certifies that it is safe. In contrast, the Senate bill, like the earlier House bill, would be effective without Thompson's certification.

Often called the "poison pill," the certification element essentially has kept Americans from legally buying drugs out of Canada. Both Thompson and Donna Shalala, President Clinton's HHS secretary, have refused to certify importation, citing safety concerns and the FDA's inability to police the practice. As required by the new Medicare law, Thompson set up a 13-member task force to study whether Americans can buy drugs from Canada without compromising their health and safety. The task force is holding a series of pubic hearings in Washington on the subject. In a recent one, Lothar Dueck, a pharmacist in Winnipeg, Manitoba, and co-founder of the Coalition for Manitoba Pharmacies, testified that Americans bent on buying drugs from Canada are creating drug shortages and higher prices for their northern neighbors. (See BioWorld Today, April 15, 2004.)

The Senate legislation would ease the pressure on Canada as it enables Americans to make purchases from certain other countries.

McCain said the Senate bill would limit American consumers, wholesalers and pharmacists to Canadian purchases the first year it is implemented - after that, the bill would allow FDA-approved pharmacists and wholesalers to import FDA-approved drugs from a larger group of nations, including the European Union, Switzerland, Australia, New Zealand and Japan.

To ensure the safety of the system, McCain said the FDA would be required to regularly inspect exporters as well as domestic importers.

Aside from McCain and Lott, Sen. Olympia Snowe, a Republican from Maine, also co-sponsored the legislation. Democrats on board are Sens. Debbie Stabenow, of Michigan; Tom Daschle, of South Dakota; Byron Dorgan, of North Dakota; Russell Feingold, of Wisconsin; Tim Johnson, of South Dakota; and Edward Kenney, of Massachusetts.