F.D.A. Begins Push to End Drug Imports

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F.D.A. Begins Push to End Drug Imports

By Gardiner Harris and Monica Davey, the New York Times

January 24, 2004

A second "blitz" inspection by federal drug and customs officials of medicines imported from Canada has found that nearly all of the almost 2,000 packages opened contained foreign versions of American pharmaceuticals that officials said might not be safe.

Five of the packages contained Serevent, an asthma medicine made by GlaxoSmithKline that had been recalled in Canada because of a manufacturing defect. People in the United States who ordered the drug from Canada "probably got that defective product and weren't notified," said Tom McGinnis, the Food and Drug Administration's chief pharmacist.

The inspections, whose results are to be formally announced next week, form part of a coordinated push by the Bush administration to stop drug imports and defuse a budding confrontation between Washington and the states.

The city governments of Springfield , Mass. , and Montgomery , Ala. , are already helping buy drugs from Canada to save money for themselves and their employees. And officials in more than a dozen states and scores of towns, cities and counties have said that they may do the same.

The F.D.A. commissioner, Mark McClellan, said in an interview that the results of the inspections, which took place in November, demonstrate that drugs ordered from Canada are often manufactured in distant corners of the world. After an earlier survey, the agency announced in September that most of the imported drugs it inspected were counterfeit knockoffs. Neither round of inspections included any chemical tests on the drugs.

Asked if the pills reviewed in the latest survey were unsafe, Dr. McClellan answered, "We just don't know, because it's so hard to tell."

Governors and mayors leading the charge for Canadian drugs flatly dismiss Dr. McClellan's safety concerns. Many point out that even though the value of drug imports from Canada probably topped $700 million last year, the F.D.A. has yet to identify a single patient harmed by the trade. And they say that Health Canada, which regulates drugs in Canada , is just as rigorous as the F.D.A.

"This has little to do with health and safety and everything to do with the pharmaceutical industry," said Peter A. Clavelle, mayor of Burlington , Vt. , who said he intended to have a Canadian drug purchase program up and running for city employees and their families by March 1.

The Bush administration is hoping to use a combination of aggressive inspections and pointed political advice to persuade local officials to back away from the border drug trade. "Our first preference is to work with them to help them lower costs," Dr. McClellan said. "But we're definitely not ruling out taking legal action against cities and states."

Some state officials say a showdown is inevitable.

"This is all going to come to a head in 2004," said Gov. Tim Pawlenty of Minnesota , a Republican. "Either the F.D.A. will sue somebody or throw someone in jail over this, or the pharmaceutical companies choke off supply, or the F.D.A. comes to their senses."

The pharmaceutical industry, which gets most of its worldwide profits in the United States because of higher prices here, had hoped that the issue died last year, when its allies in Congress fought off a bill that would have legalized imports from 25 countries, including Canada .

Instead, Congress included a provision in the Medicare drug legislation passed in November that allows imports only if the administration deems them safe, something it has steadfastly refused to do. The industry also hoped that the bill's promise of a drug benefit for the elderly beginning in 2006 would reduce pressure for drug price cuts.

"We need more and better coverage, and Congress began the process of resolving the situation when it passed the Medicare law," said Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, the industry's trade group.

But even those with health insurance are being forced by insurers to bear an increasing share of drug expenses, making many Americans increasingly sensitive to those costs.

Because the Canadian government negotiates on behalf of all of its citizens, prices there for branded drugs are, on average, about half those in the United States, fueling what has become a vigorous, if illegal, cross-border trade.

A number of governors say they have had tense meetings in Washington with federal drug officials, even as they talk regularly with Canadian pharmacists. This month, Gov. Jim Doyle of Wisconsin focused on the issue during the Democrats' weekly radio address.

"I don't understand why the federal government isn't on our side, trying to get this done for our citizens," he said.

A group of governors will meet in Washington after the National Governors Conference next month to discuss drug importation.

By then, Dr. McClellan expects to have a joint report by the F.D.A. and the government's Centers for Medicare and Medicaid Services that, he said, will detail a half-dozen ways that states can legally cut their drug bills. Among the mechanisms, Dr. McClellan said, are mandated switches to generics when they are available and programs that encourage patients to take cheaper over-the-counter drugs in place of expensive prescription pills for conditions like hay fever and heartburn.

Many state drug administrators say that they have either adopted or are already studying these measures.

"We've been looking at every concept out there to get potential savings," said Kevin Goodno, Minnesota 's commissioner of human services.

Scott McKibbin, coordinator of Illinois 's drug programs, said the state had carried out numerous changes to save money. More could be done, he acknowledged, "and we're already looking at those things." Gov. Rod R. Blagojevich of Illinois , a Democrat, has asked the federal government for permission to import drugs from Canada for state employees and retirees. Federal drug officials said that they had yet to sue any local government largely because few states and cities had carried out plans to import drugs. They are also waiting for the ideal case.

"When we're considering our legal options, we will look for places where there is the most public health risk," said Peter Pitts, an F.D.A. spokesman.

F.D.A. officials said that their contacts with Springfield, Mass., and Montgomery, Ala. - the only places actually importing drugs from Canada - had left them hoping those cities would end their programs without legal action. The agency on Thursday issued warning letters to three companies in Temple , Tex. , that the agency claims aid Montgomery 's import program.

Officials of both cities, however, said that buying Canadian drugs had led to substantial savings and that they had no plans to end the programs.

In part, though, the programs may be successful because they are rare. Canadian pharmacists say that they cannot possibly supply drugs to all the states that have expressed interest in purchasing from Canada .

"We just can't sustain that kind of volume here in Canada ," said David MacKay, executive director of the Canadian International Pharmacy Association, which represents pharmacies that export drugs to the United States .

Illinois alone buys about $2 billion worth of drugs annually. Mr. MacKay said Canadian pharmacies might be able to supply $1 billion worth of drugs this year to the entire United States .

One limiting factor is that most major drug manufacturers are fighting the cross-border trade by restricting supplies to Canadian pharmacies. Indeed, even advocates of drug imports acknowledge that Canadian supplies are limited.

"We're not saying this is a solution," said Mr. Clavelle of Burlington , Vt. "It's a Band-Aid, and a Band-Aid that needs to be applied."

In the meantime, local officials say their constituents are clamoring for relief.

"You cannot even talk to seniors - middle-class seniors - without hearing about this," said Alex Penelas, mayor of Miami-Dade County , Fla.