FDA eases stance on importing medicines

"We're not considering legal action against cities or states," said William K. Hubbard, associate commissioner for policy and planning at the FDA.

The statement, made after a meeting with members of the state Senate Committee on Health Care, gives a boost to programs such as the one in Springfield, where Mayor Michael Albano has contracted with a private supplier to provide prescription drugs from Canada to city employees in hopes of saving as much as $9 million a year. Other Massachusetts cities, including Worcester, Lowell, Revere, and Pittsfield, are considering similar plans.

"This is a big admission," said state Senator Jarrett T. Barrios, Democrat of Cambridge and vice chairman of the committee, who seeks to create a state-sponsored clearinghouse of drug importation information. "Is it a green light to cities? No. But it's a yellow light that says proceed with caution. It's an acknowledgement that cities are responsibly pursuing their obligation to take care of the employees while being fiscally responsible."

Hubbard made his comments after a meeting with members of the healthcare committee. It was one of a series of meetings the FDA has had with cities and states that are considering following Springfield's lead in defiance of FDA warnings.

Hubbard said the FDA would continue its court battles against "businesses that sell commercial quantities of drugs" from overseas. The agency sent a cease-and-desist letter last month to CanaRx, the company that arranges for Canadian drugs to be shipped to Springfield. The Justice Department is awaiting a ruling after suing in Oklahoma to shut down a chain of stores that provide Canadian drugs under the names Rx Depot and Rx of Canada.

The FDA previously had indicated that it would not pursue Albano and Governor Tim Pawlenty of Minnesota, who plans to set up a website to help Minnesotans buy drugs from Canada at prices negotiated by the state, but the agency had not offered a blanket amnesty for public officials.

Despite the concession, Hubbard underscored the FDA's concerns about the safety of drugs purchased from other countries.

" `Buyer beware' isn't a system that works for drug purchasing," he said. "It's very easy to be injured by a drug."

Barrios said the safety issue is a red herring when Americans are buying drugs that were manufactured in FDA-approved facilities in the United States and handled by licensed pharmacies in Canada.

"The FDA continues to act like the proverbial ostrich with its head in the sand," he said. "It describes a world of disastrous consequences it would rather not look at."

Hubbard said the agency doesn't have the authority to write regulations necessary to implement safe importation of drugs from other countries. Such action would require additional authorization from Congress, he said.

That contention drew criticism from US Representative Marty Meehan, Democrat of Lowell, who said the Medicine Equity and Drug Safety Act of 2000 accomplished just that. But the FDA and Secretary of Health and Human Services Tommy G. Thompson haven't acted on the law, he said.

Albano, who has ignited a nationwide movement with his city drug import plan, had a laugh when told of the FDA's position. "This is a major reversal of the FDA policy, who in their own way gave me fair warning when I met with them in September," he said in a telephone interview. "I'm sure my wife will be happy when she hears the FDA won't be knocking our door down."

Jeffrey Krasner can be reached at krasner@globe.com.