WASHINGTON – Lawmakers get an opportunity this week to cast election-year votes both for and against allowing prescription drug imports (search) — roll calls they can tout separately to voters at home and to pharmaceutical companies and officials helping finance many of their campaigns.
An agriculture spending bill currently has a provision opening the way for imports by preventing the Food and Drug Administration (search) from blocking purchases of FDA-approved drugs from Canada and other countries. Those imports generally carry prices about one-third lower than those charged in the United States.
But also scheduled this week is a vote on approving a U.S.-Australia free-trade agreement (search), the first trade pact to include specific provisions dealing with non-tariff market access issues related to pharmaceuticals.
Both bills are likely to pass by sizable majorities.
The trade agreement, reached by the two countries in February, requires Australia to be more transparent in deciding its list of government-subsidized drugs and gives U.S. drug companies greater opportunities to seek reviews of those decisions.
The treaty also includes the U.S. law that gives patent holders the right to control sales of their product in the United States by making that law a part of the treaty.
Sen. Byron Dorgan, D-N.D., who has led Senate efforts to remove a ban on prescription drug imports, said the Bush administration was using the trade deal to reinforce its opposition to imported drugs.
"It's a bizarre provision to put in a trade agreement," he said. "It's anti-consumer and pro-pharmaceutical industry."
But the office of the U.S. Trade Representative (search), which negotiated the agreement, said it was merely confirming patent law (search) that has been on the books for a century. Officials noted that a Singapore trade agreement ratified last year had similar language.
"The agreement reflects long-standing and bipartisan U.S. law," said Ralph Ives, assistant U.S. Trade Representative for Southeast Asia and Pharmaceutical Policy. "Congress told us in the Trade Act to negotiate an agreement that reflects current law."
Rep. Phil Crane, R-Ill., head of the House Ways and Means trade subcommittee, joined Rep. Jennifer Dunn, R-Wash., another subcommittee member, in telling colleagues the trade pact in no way prevented Congress from changing U.S. laws concerning importation. "This argument is false," they said.
Australian Embassy spokesman Matt Francis said his government, in negotiating the agreement, held fast in insisting it make no change that drove up the cost of drugs to Australian consumers or weakened Australia's sovereignty over prices charged there.
House Speaker Dennis Hastert, R-Ill., earlier threatened to block a vote on the agreement pending a U.S. study on how whether foreign price controls excessively shift the cost of researching and developing new drugs to American consumers.
But Hastert eased his opposition in May, saying he was more confident the administration was pressuring other nations to make drug prices more subject to market forces.
Francis also noted that Australia bans the export of its subsidized drugs, which make up 90 percent of drugs sold in the country, ruling out U.S. access to cheap Australian drugs.
Congress has tried for several years to legalize the importation of less expensive drugs from Canada and other countries, but has been stymied by strong opposition from the administration and the pharmaceutical industry.
Language that would have lifted FDA restrictions on imports was deleted from last year's agriculture bill. The Medicare law enacted last year essentially reaffirmed existing law that allows imports only if the Health and Human Services Department certifies their safety. The department under both the Clinton and Bush administrations has withheld such certifications.
In the latest effort, Rep. Marcy Kaptur, D-Ohio, last month won an 8-6 vote in the House Appropriations agriculture subcommittee to allow imports from Canada and other countries where price controls have made prescription drugs cheaper.
Drug importation legislation has had an even tougher time in the Senate, but Dorgan said he had a promise from Majority Leader Bill Frist, R-Tenn., who opposes imports, that the issue would reach the Senate floor this year. "If we get a fair vote we will prevail," he said.