Import option may threaten drug-safety legislation

The Senate, giving a boost to a measure long favored by congressional Democrats, on Thursday opened the door to letting American consumers save money on prescription medicines by ordering them directly from Canada and other developed countries where prices are lower.

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 against potentially dangerous medications. The reform plan includes increased funding for drug safety and creation of a nationwide computer surveillance system designed to spot problems with medications approved for the market.

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.

Proponents of allowing consumers to buy drugs from Canada and other sources, who have argued that removing the current ban would cut health-care costs, are trying to attach the proposal to the FDA bill. The bill is considered must-pass legislation, because it includes the new safety measures and a new user-fee agreement with industry that is critical for the FDA's overall budget.

Advocates of allowing drug imports, led by Sen. Byron Dorgan, D-N.D., won a 63-28 procedural vote Thursday to allow full debate on their 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 skirmishing

Pharmaceutical companies -- whose user fees now pay about half the cost of reviewing new drugs -- are determined to stop the import bill.

The industry has powerful leverage. Before the import measure was put forward, it had agreed to support higher user fees to cover most of the cost for improving the drug-safety system. That agreement may now be in jeopardy.

President Bush's advisers have threatened to recommend a veto of the FDA safety and funding bill if the import language remains. Senate Republicans have scrambled to line up support for an amendment that would effectively undo Dorgan's proposal.

The fast-moving developments have put consumer groups in a quandary. Advocates back both a stronger safety system and freer access to medications from abroad.

"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 takes its summer break, the FDA would have to start issuing layoff notices to 2,000 employees, including hundreds of senior-level scientists, physicians and statisticians in its new drugs office.

Dorgan said he was not trying to undermine the safety legislation, but merely 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 on the Senate floor.

Opponents of his bill say lifting import restrictions could result in an avalanche of counterfeit pills, an argument also made by the 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," Health and Human Services Secretary Michael Leavitt said.

The broader FDA funding bill calls for $478 million in industry user fees next year, rising to $841 million in 2012. Of the allocation for 2008, more than $70 million would be used to revamp the FDA's safety system.

The bill would create a new computerized network to scan medical insurance and pharmacy records for signs of trouble with approved drugs, and would significantly bolster the FDA's authority to require that drug companies take steps to protect patients when problems arise.

The House has not yet acted on its version of the legislation.

Source : http://www.latimes.com