Import debate colors drug-safety proposal (USA Today)

By Ken Dilanian, USA TODAY

The Senate grappled Wednesday with the hot-button question of whether to allow the importation of cheaper drugs from other countries and debated the influence of the drug lobby, as it moved closer to passing the most significant changes to drug-safety rules in decades.The legislation, which has bipartisan support, draws from the recommendations of the non-partisan Institute of Medicine, which last fall called for an overhaul of the Food and Drug Administration's drug monitoring system. The FDA requested the report after the painkiller Vioxx was pulled from the market in September 2004 because of a high risk of heart attacks and strokes. The proposal, sponsored by Sens. Edward Kennedy, D-Mass., and Mike Enzi, R-Wyo., would empower the FDA for the first time to closely track the safety of drugs after they are approved for sale, including requiring post-approval scientific studies by drugmakers. The measure also would require the results of all clinical trials of new drugs to be published to ensure negative information is not withheld from the public.Kennedy, who chairs the Senate health committee, attached the safety proposal to a must-pass bill that would reauthorize and increase user fees paid by drug and medical-device companies to help fund the FDA's system of approving new medical products.Kennedy and Enzi made changes in the bill that addressed the concerns of various senators, making passage more likely, both lawmakers said.Some of those changes, requested by the drug industry, had the effect of "watering down" the bill, said Michael Gaba, a partner with the law firm of Holland & Knight, which lobbies for drug companies and medical-device makers. But drug companies had to accept the gist of the bill, despite misgivings, because "the political reality is such that they can't just wipe ... away" safety concerns, he said."The FDA should be the gold standard for safety, but its luster has been tarnished in recent years by failure to protect the American people from unsafe drugs," Kennedy said on the Senate floor.Lobbying influence debated While the main provisions attracted broad support, the bill became embroiled Wednesday in a familiar debate about whether Americans should be allowed to import lower-priced drugs from other countries, a practice that is currently illegal even though it is widely engaged in by residents of states bordering Canada. Byron Dorgan, D-N.D., and Olympia Snowe, R-Maine, offered an amendment to allow it. On the Senate floor, Dorgan held up two bottles of the cholesterol-lowering drug Lipitor, both produced at an FDA-approved plant in Ireland, and argued that it made no sense that Americans paid double the Canadian price for the same pill.Opponents, including Enzi and Judd Gregg, R-N.H., countered that importing drugs posed a safety risk. Under Dorgan's amendment, "a lot of people are going to get hurt, and some are going to die," Gregg said.Dorgan and his allies said their bill includes safeguards to ensure the drugs are only imported from developed countries with sound safety standards. "All the protestation on the Senate floor on this issue is protestation on behalf of the pharmaceutical industry," he added. Gregg denied that he was "a tool of the drug industry," noting that he voted against the prescription-drug program for seniors last year that the industry furiously lobbied to get passed.Later, Sen. Bernie Sanders, I-Vt., spoke in pointed terms about what he described as the "enormous" power of the drug companies over Congress.He noted figures showing that since 1998, the pharmaceutical industry has spent more than $900 million on federal lobbying. The 1,200 registered prescription-drug lobbyists "descend like locusts into the offices of members of Congress and say, 'Don't vote for change. Keep the status quo alive. Make sure that the American people continue to pay the highest prices for medicine in the entire world,' " Sanders said."Since 2000 ... the pharmaceutical companies have contributed almost $250 million in campaign contributions," he said, adding that the real question was "whether the Congress of the United States is in fact prepared to stand up to the most powerful, the greediest special interest in the United States of America." 'We're ... saving lives' Ken Johnson, senior vice president at Pharmaceutical Research and Manufacturers of America, responded: "A large amount of that money is spent trying to defeat bad public policy. Somehow he forgot to mention that we're committed to saving lives and improving the quality of life for most Americans."Lawmakers uniformly reject the notion that they are influenced by political contributions, and public records indicate that senators on both sides of various drug issues have received campaign money from pharmaceutical interests.Nevertheless, many senators whose positions were aligned with those of the drug industry in the current debate have raised large sums in recent years from pharmaceutical interests.For example, eight senators co-sponsored an amendment requiring the U.S. Health and Human Services secretary to certify that importing drugs from other countries posed no increased risk. Dorgan and others said that amendment was designed to kill his proposal, since no official could make such a certification about any imported product.Together, those eight senators Democrats Tom Carper of Delaware, Ben Nelson of Nebraska, Robert Menendez of New Jersey, and Republicans Thad Cochran of Mississippi, Orrin Hatch and Bob Bennett both of Utah, Richard Burr of North Carolina, and Enzi raised $1.6 million from drug company executives in the last six years, according to a USA TODAY analysis of figures compiled by the Center for Responsive Politics, a non-partisan group that tracks campaign money.Enzi's spokesman, Craig Orfield, said Enzi "looks at the substance of each issue," building strong support for problem-solving solutions rather than building a record that wins points with special interests or their lobbyists. The importation issue is scheduled to come up for a vote Thursday. The White House has threatened a veto the bill if that provision gets in the bill. The overall bill is likely to be voted on by week's end.