Washington Editor

WASHINGTON - A Supreme Court decision to remand a lawsuit between the pharmaceutical lobby and the state of Maine back to district court has some lawmakers cheering as if the court ruled against the industry.

But neither the lobby nor the state has yet to claim victory in the case surrounding Maine Rx, a prescription drug program for the state's 325,000 poor and uninsured residents.

The court issued a 6-3 ruling in favor of returning the case between the Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA) and Maine to the lower court, which previously held that Maine Rx did not benefit Medicaid patients.

PhRMA said the program interferes with the nationwide federal Medicaid program and violates the commerce clause of the Constitution, which prohibits states from regulating transactions outside their borders. Maine Rx would give the state power to negotiate bulk discount rates. (See BioWorld Today, July 1, 2002, and Oct. 30, 2000.)

PhRMA released a prepared statement saying it continues to review the Supreme Court's "complex, multifaceted opinions."

Meanwhile, Lee Umphrey, spokesman for Maine Gov. John Baldacci, told BioWorld Today the state doesn't interpret the decision as a victory. "We just see it as another positive step toward what was initially planned and we believe Maine will be a leader in developing initiatives like this."

In his remarks following the decision, Umphrey said the governor was cautious, yet positive.

Others are not nearly as cautious. Rep. Bernie Sanders (I-Vt.), whose distaste for the drug industry is palpable, released a statement applauding the Supreme Court. "This is a great victory for the millions of people around this country who are struggling to afford prescription drugs. There is no doubt in my mind that the pharmaceutical companies will fight vigorously to undermine this ruling and will stop at nothing to protect their profits."

And Sen. Debbie Stabenow, a Democrat from Michigan who believes states should have the right to negotiate lower drug prices for their uninsured residents, issued a statement saying the state of Maine is acting responsibly in looking to help its uninsured residents. "Although the court's ruling leaves the door open for additional drug company court challenges, the ruling is a victory for the uninsured residents of Maine and the uninsured residents of all states where similar legislation is being drafted."

Stabenow, along with others including Chuck Schumer (D-N.Y.), introduced the Rx Flexibility for States Act, legislation designed to clarify current laws that may prevent states from providing lower-priced prescription drugs to all residents. According to the legislation, states would be able to extend Medicaid rebates and discounts for prescription drugs to non-Medicaid-eligible people.

The ruling allows Maine to implement the program while a district court determines if the program would be harmful to patients and what the benefit would be, Bruce Lott, spokesman for PhRMA, told BioWorld Today.

But since Maine Rx reforms the state's Medicaid program, it must be approved by Tommy Thompson, secretary of Health and Human Services.

Maine Rx includes an authorization requirement that would force physicians to gain state approval before prescribing a drug. Also, the program would give the state attorney general the right to bring action against a prescription drug manufacturer for charging an unfit or undue price.

As an insight into the court's viewpoint, PhRMA included a couple of opinions written by the justices. Justice John Paul Stevens' opinion makes clear that the decision does not determine the validity of Maine's Rx program, and Justice Sandra Day O'Connor's dissent emphasized that the district court already had concrete evidence of the burdens that Maine Rx's prior authorization requirement would impose on Medicaid beneficiaries.

"We believe that further factual development will support that conclusion," Marjorie Powell, PhRMA spokeswoman, said in a prepared statement.