WASHINGTON - Acting on one of the election year's hottest issues, an overwhelming majority in Congress has voted to lift a ban on the importation of prescription drugs as a protest against the much higher prices charged for pharmaceuticals in the United States.
It's not yet clear whether recent votes in the House and Senate will lead to greater access for Americans to discount drugs. But the votes sent shock waves through the politically well-connected pharmaceutical industry, which is spending millions to fight price controls.
The House voted 370-12 earlier this month to amend an agriculture spending bill to prohibit the Food and Drug Administration from enforcing the ban against bringing prescription drugs purchased outside the country into the United States.
Lawmakers said their goal was to facilitate access to medicines sold in Canada and Mexico, most of which are made by U.S. manufacturers but are sold in those countries at prices as much as 70 percent below what the same drugs cost here.
More stunning was a Senate vote this week of 74-21 on a spending bill amendment offered by Vermont Republican James M. Jeffords that calls upon the FDA to allow pharmacists and wholesalers to import U.S.-made drugs from other countries and to regulate the process to ensure they are safe.
"Seventy-four votes was very surprising," said Sen. Byron L. Dorgan, a North Dakota Democrat and another leading advocate of the proposal. "It suggested a real depth of support, and it also indicated what we know: that drug prices are a very big issue."
The pharmaceutical industry, which ran full-page advertisements in 30 newspapers around the nation this week warning against the dangers of allowing counterfeit drugs into the country, was taken aback.
"Neither of those amendments should have gotten this far," said Jeffrey Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America. "We are very concerned."
Final action on the import ban is not expected until Congress returns in the fall from its summer recess. But the recent votes are likely to be recounted on the campaign trail next month as lawmakers try to persuade voters that they are dealing with an increasingly hot consumer issue that has potential life-or-death consequences.
"I call them 'feel good amendments,'" said Sen. John B. Breaux of Louisiana, one of only two Democrats to vote against the Jeffords proposal. He predicted that the FDA could not put into effect a program that requires it to certify the safety and quality of drugs coming in from all over the world.
But the FDA, which worked closely with Jeffords on his amendment, says it can do the job if it gets some extra money, according to spokesman Lawrence Bachoric.
"This is a rather crude, but workable solution to the problem on a temporary basis," Jeffords said. "In the long run, we've got to find other ways to do it."
Lifting the import ban is one of a variety of approaches for coping with drug prices that some lawmakers say have soared beyond reason in this country.
The predicament is greatest for elderly Americans, who rely most heavily on prescription medicines but in two of three cases don't have insurance to help buy the drugs.
Worse, drug makers charge people without insurance a higher price for their products because insurance companies are able to negotiate bulk discounts.
Border states are rife with tales of busloads of elderly Americans traveling to Canada or Mexico to buy drugs where the government-run health systems can beat the U.S. prices.
Maine recently became the first of the border states to respond by setting up its own program to negotiate bulk drug purchases for its uninsured residents. New Hampshire and Vermont are expected to quickly follow. There is talk that all six New England states and New York might join in a drug-buying compact.
Rep. Tom H. Allen, a Maine Democrat, is sponsoring legislation that would set up a federal program of buying drugs in bulk to obtain discounted prices for elderly Americans without insurance.
The drug industry argues that price controls in Canada, Mexico and other countries have stifled research and innovation there and would do the same in this country.
"The real solution is to expand drug coverage for those who most need it - elderly and disabled Americans - ensuring quality and containing health care costs through marketplace choice and competition, not through government controls," Alan F. Holmer, president of the PHRMA, said in a statement after the Jeffords amendment passed.
President Clinton and lawmakers in both parties have proposed helping older Americans obtain prescription medicines by providing a drug benefit through Medicare. The House passed a Republican bill last month that would subsidize insurance companies to offer "drug only" policies to Medicare beneficiaries.
But Clinton has threatened to veto the House bill, which the drug industry also opposes, and the Senate has so far been unable to produce an alternative.
Oklahoma Republican Tom Coburn, a lead sponsor of the House amendment on lifting the drug import ban, says providing a Medicare drug benefit without addressing the price problem would only make it worse.
"It's not just our seniors; everybody in this country is paying too much for drugs," said Coburn, who complained to his colleagues of price collusion by the drug companies. "The number-one thing is to have a competitive market for prices in this country."
Jeffords agreed that U.S. patent laws and other protections for the drug industry might have to be re-examined as part of a longer-term solution to high prices.
Some advocates of lifting the import ban say just passing the legislation would be enough.
"Our goal is not to force U.S. consumers to access drugs outside of this country, but to force the pharmaceutical industry to re-price," Dorgan said. "I don't think there's any question it would force a re-pricing."
With stakes that high, though, Dorgan predicted the industry opposition will be fierce: "They're spending an enormous amount of money to derail this, and I don't underestimate their ability."