Vt. suit against FDA cheered in Md.

Imports: Montgomery, state lawmakers oppose ban on Canadian drugs.

August 12, 2004|By Paul Adams | Paul Adams,SUN STAFF

Some state and Montgomery County lawmakers are cheering Vermont's decision yesterday to sue the U.S. Food and Drug Administration for denying its request to import prescription drugs from Canada, saying the move will raise the legal stakes as they battle to implement similar cost-saving programs in Maryland.

Vermont is one of a growing number of states and municipalities nationwide that are challenging the FDA by trying to import cheaper drugs from Canada, where the government negotiates with manufacturers for price discounts of up to 50 percent off what U.S. consumers pay.

Vermont health officials asked the FDA in December for a waiver from the federal government's ban on drug imports, but the agency rejected the request on the grounds that it couldn't guarantee the safety of drugs ordered online from pharmacies outside the United States.

Vermont Gov. James Douglas rejected that argument and vowed to pursue "any and all legal remedies."

The state's defiant stance will undoubtedly spur election-year debate over how to lower the rising cost of prescription drugs, which consume about 10 cents of every health care dollar. Democratic presidential nominee John Kerry has said he favors drug importation, while the Bush administration has raised questions about safety.

The legal standoff also comes as Montgomery County is laying the groundwork to implement a drug importation program that officials say could save the county up to $15 million a year. State lawmakers also have entered the fray, with legislation nearly passing this year that would have directed health officials to seek FDA permission for an importation plan in Maryland.

"The momentum, it's like a tsunami right now," said Sen. Paul G. Pinsky, a Prince George's County Democrat who introduced a bill in the last legislative session similar to the Vermont proposal. "I think there's a dynamic happening. Each day it's a different state, a different city, a different county, and Congress is just not going to be able to ignore it."

Pinsky's bill would have established a Canadian drug importation plan for Maryland Medicaid recipients and current and retired state employees. But the plan hinged on the FDA granting a waiver similar to the one requested by Vermont. The bill had wide support, but the clock ran out on the session before a vote was taken.

Pinsky says he may bring the legislation back next year. And he predicts the FDA won't stand in the way of local governments, despite the agency's tough talk.

"They [the Bush administration] have an election in November and if they try to stop this, they're going to lose in whatever state they try to intervene in," he said. "The public wants lower prescription drug prices. It's just a no-brainer."

In rejecting Vermont's request, the FDA stuck to its argument that drugs imported from other countries pose safety risks to consumers. Drugs sold in the United States are regulated by the FDA and must meet safety guidelines.

"The bigger issue is whether safety is worth the cost advantage by importing these drugs," said William Hubbard, the FDA's associate commissioner for policy and planning. "We have some evidence that these drugs are not always safe, and so, therefore, it's a tough call."

The Montgomery County Council has thumbed its nose at the FDA, voting July 27th to seek bids to implement its drug importation plan. The county, which is home to FDA headquarters, spends about $60 million a year on prescription drugs for its 26,000 current and former employees.

The county's plan would allow those employees to avoid all co-pays by ordering certain maintenance drugs, such as blood-pressure medication, through a pharmacy in Canada. The plan focuses on a limited number of maintenance drugs, since they tend to be widely used and deemed safe by FDA standards.

The drug importation plan is patterned after similar programs in Boston and Springfield, Mass., and several other municipalities. Several states, including Wisconsin and Minnesota, also have come up with plans to make it easier for employees to buy drugs from Canada. The FDA has warned Montgomery County that its plan is illegal.

"We've concluded that we can do it legally," said Tom Perez, the Montgomery County councilman who sponsored the measure. "If it was so illegal, why hasn't the FDA sued the city of Springfield? Why hasn't the FDA sued the city of Montgomery, Ala.? Why haven't they sued the state of Wisconsin or Minnesota?"

Hubbard said the FDA has so far tried to focus on educating state and municipal lawmakers about their safety concerns, rather than suing. But he warned that Montgomery County and others could face legal action.

"Some jurisdictions have proceeded anyway and it's possible at some point that we'll have to ask a federal judge to referee this thing," he said. He credited Vermont for pursuing the proper legal avenues to resolve the dispute, rather than acting unilaterally.

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