US Senate drug bill would set worldwide marketplace
A drug importation bill filed yesterday in the US Senate would set up a vast international marketplace for prescription medicine as part of an effort to loosen the drug industry's grip on supplies available to American consumers.
Under an importation oversight system that would be established by the Senate bill, American consumers could legally get drugs from not just from Canada but some 22 other countries, including members of the European Union, Switzerland, Australia, New Zealand and Japan.
Senator Edward M. Kennedy of Massachusetts, part of a high-profile, bipartisan group that filed the bill, said in a written statement that about 25 percent of drugs legally consumed by Americans are already manufactured overseas and then imported to the United States by large pharmaceutical companies.
''If drug companies can import drugs at high prices, why can't patients import them at fair prices?" said Kennedy.
The bill essentially would allow consumers to go shopping in a worldwide market, where drugs that are identical to those available in the US are for sale in foreign countries with government price controls. Those drugs originate from the United States or manufacturing plants around the world that have been inspected and approved by the US Food and Drug Administration. Imports from Canada by individual consumers would begin immediately. Shipments from other countries could begin one year after enactment.
The price differences are considerable. Discounts of 20 to 80 percent over US prices, for example, have already fueled an illegal import trade from Canada worth at least $700 million a year.
The FDA and the drug industry have opposed importing prescription drugs because they say it's not safe. They say tapping foreign distribution channels exposes Americans to potentially counterfeit or improperly handled drugs. The industry's Washington lobbying arm, the Pharmaceutical Research and Manufacturers of America, reiterated its opposition yesterday.
''This bill undercuts the FDA's ability to protect patients' health and will potentially allow foreign versions of medicines from over 22 countries into the United States, including medicines from places like Latvia, Estonia and Slovenia," Alan F. Holmer, PhRMA's president and CEO, said in a statement. ''It opens the door for un-approved and un-traceable medicines to flow onto pharmacy shelves across America."
The FDA said yesterday it stands by its opposition to imports. William Hubbard, the agency's associate director for policy and planning, said the bill also appeared to contain a provision that would allow importation of medications that are merely similar, not exactly the same, as FDA-approved drugs. He called that a dangerous precedent.
The bill was filed by a bipartisan group of senators, including Democrats Kennedy, Byron Dorgan of North Dakota, and Tom Daschle of South Dakota; and Republicans John McCain of Arizona and Olympia Snowe of Maine. It also picked up last-minute, additional sponsors in Republican Trent Lott of Mississippi and Democrat Debbie Stabenow of Michigan. The presence of senators from both sides of the aisle is evidence of growing support for drug importation in the Senate, which killed a House-passed measure last year.
Proponents say a main purpose of the bill is to undermine the tight wholesale restrictions that drug manufacturers have placed on Canadian Internet pharmacies they suspect of illegally filling cross-border prescriptions for Americans. With so many countries available as sources, it would also make such restrictions difficult to establish elsewhere.
''It will be much harder for the manufacturers to limit supply to an entire European Union market," said Daren Jorgenson, founder of Canadameds.com in Winnipeg, Manitoba. ''American pharmacies could access product from a much larger inventory base than just Canada, so hopefully that would affect the American consumer price."
Responding to shortages in Canada imposed by drug makers, Canadameds.com is among the Canadian Internet pharmacies that have already begun offering its American customers the option of receiving prescriptions directly from pharmacies in England. It plans to offer a service from New Zealand next week, Jorgenson said.
Christopher Rowland can be reached at crowland@globe.com.
