The Senate, giving a boost to a measure long favored by congressional Democrats, opened the door Thursday to letting American consumers save money on prescription medicines by ordering them from Canada and other developed countries where prices are lower.
But the move could have an unintended side effect -- derailing a long-awaited, bipartisan effort to improve the Food and Drug Administration’s faltering system for protecting patients from potentially dangerous medications. The reform plan includes increased funding for drug safety and the creation of a nationwide computer surveillance system designed to spot problems with medications.
The proposed improvements were developed in response to highly publicized safety lapses, including the belated withdrawal of the diabetes drug Rezulin and the painkiller Vioxx.
Those who want to let consumers buy drugs from Canada and other places are trying to attach the proposal to the FDA bill. They argue that removing the ban would cut healthcare costs. The bill is considered must-pass legislation because it includes the safety measures and a user-fee agreement with the pharmaceutical industry that is crucial to the FDA’s budget.
On Thursday, advocates of allowing drug imports, led by Sen. Byron L. Dorgan (D-N.D.), won a 63-28 procedural vote to allow a full debate on the amendment.
As a result, instead of an expected vote to approve revamping the drug safety system, the Senate put off action until next week -- and set off new political skirmishes.
Pharmaceutical companies, whose user fees pay about half the cost of reviewing new drugs, are determined to stop the import bill. And the industry has leverage.
Not only does it spend freely on lobbying and campaign contributions, but before the import measure was put forward, it had agreed to support higher user fees to cover most of the cost to improve the drug safety system. That agreement may be in jeopardy.
President Bush’s advisors have threatened to recommend a veto of the FDA safety and funding bill if the drug import language remains. Senate Republicans are scrambling to line up support for an amendment that would effectively undo Dorgan’s proposal.
The developments have put consumer groups in a quandary. Advocates back a stronger safety system and better access to medications.
“It’s going to be a long summer,” said William Vaughan, a health policy analyst for Consumers Union, publisher of Consumer Reports. “This could be like the Iraq situation. If we get a veto, then somebody has to blink.”
Without a new user fee bill by the time Congress leaves for summer, the FDA would have to start issuing layoff notices to 2,000 employees, including hundreds of senior-level scientists, physicians and statisticians.
If the Senate were to allow the purchase of lower-cost drugs from suppliers outside the United States, it could signal the end of a years-long stalemate. The House has voted to allow the importation of medicines. But similar efforts have always been blocked in the Senate.
Consumers pay less in Canada and other countries because the governments impose price controls on prescription drugs. With some limited exceptions, it’s illegal to bring drugs into the United States from other countries, and periodically the government seizes shipments from Canada and elsewhere.
Dorgan said he was not trying to undermine the safety legislation but to secure the benefits of free trade for U.S. patients, many of whom have no health insurance and must pay retail prices for medications.
“Why should American consumers pay the highest prices in the world?” Dorgan asked during debate in the Senate.
Opponents said lifting import restrictions could result in an avalanche of counterfeit pills, an argument made by pharmaceutical companies.
“Allowing the importation of drugs outside the current safety system would pose an immediate and significant risk to the public health in the United States,” said Health and Human Services Secretary Michael Leavitt.
The FDA funding bill calls for $478 million in industry user fees next year, increasing to $841 million in 2012. In 2008, more than $70 million would be used to overhaul the FDA’s safety system.
The bill would create a computerized network to scan medical insurance and pharmacy records for signs of trouble with approved drugs, and would bolster the FDA’s authority to require drug companies to take steps to protect patients when problems arose.
The House has not acted on its version of the legislation.