Washington Editor

Pressure on the Bush administration to support some form of prescription drug importation continues to grow as more lawmakers take steps to legalize the practice.

This time around, the pressure is coming from Sen. Judd Gregg's office. Gregg (R-N.H.), chairman of the Senate Committee on Health, Education, Labor and Pensions, introduced legislation (referred to as the Safe Importing of Medical Products and Rx Therapies Act) that would allow Americans to import from Canada now, and from the European Union in three years.

Through a user-fee program that would be imposed on all businesses engaged in importation, Gregg believes the government could provide the FDA with adequate resources to regulate the program in the same way that the agency regulates imported food.

Gregg's co-sponsors are Senate Republicans Gordon Smith (Ore.), Susan Collins (Maine), Norm Coleman (Minn.), Trent Lott (Miss.), Mike Enzi (Wyo.) and Jeff Sessions (Ala.).

Lott, once an opponent of importation, is among the senators who co-sponsored an earlier bipartisan piece of legislation that would punish drug companies that seek to protect and control their products by limiting sales to Canadian wholesalers and pharmacies. (See BioWorld Today, April 23, 2004.)

In part, the bipartisan legislation was meant to respond to companies such as New York-based Pfizer Inc. and London-based GlaxoSmithKline plc, which limited shipments to Canadian wholesalers or pharmacies known to sell drugs 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.)

In a 243-186 vote last year, the Republican-controlled House approved similar legislation that would stop companies from limiting sales to foreign wholesalers and pharmacies, referring to those tactics as unfair trade practices.

Meanwhile, the new Medicare law signed by President Bush in December would legalize importation of prescription drugs if Health and Human Services Secretary Tommy Thompson certifies that it is safe.

Often called a "poison pill," the certification element essentially has kept Americans from legally buying drugs from Canada. (While FDA policy prohibits importation, historically the agency has not enforced those rules.)

Nevertheless, both Thompson and Donna Shalala, President Clinton's HHS secretary, 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. In a recent public hearing, 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.)

But Gregg's bill eventually would take some pressure off Canada because it would open the door to other countries. Gregg's office said the bill would:

Allow importation of commercial quantities of FDA-approved prescription drugs by pharmacies and wholesalers within a year. Imported drugs would have to be labeled in order to help patients make informed choices.

Ensure that Internet pharmacies are legitimate, licensed and accountable. The legislation would require online pharmacies to be registered, and would prohibit credit card companies from authorizing sales to nonregistered Internet pharmacies.

Permit unapproved products to be imported under a "compassionate use" exemption to continue medical treatment for a serious medical condition begun overseas. (That practice is permitted under current FDA policy.)