Bill to Ease Imports of Less Expensive Drugs Gains in House

By Sheryl Gay Stolberg and Gardiner Harris

WASHINGTON, July 21 -- A bill that would make it easier for Americans to import inexpensive prescription medicines from Canada and Europe is gathering support among some Republicans in the House of Representatives, prompting a furious effort by the pharmaceutical industry to defeat the legislation when it comes up for a vote later this week. Advertisement

The so-called "reimportation" bill, which would legalize the importation of drugs already sold in the United States, does not have the support of House Republican leaders. They are bringing it up for consideration as part of a deal they struck with a Missouri Republican, Representative Jo Ann Emerson, to secure Mrs. Emerson's vote in favor of a broad Medicare prescription drug benefit, a measure that is a priority of the White House.

Under the terms of that deal, the leaders promised not to fight the reimportation bill. Now, in a somewhat surprising turn, a number of Republicans say they intend to vote for it.

In the past, many Republicans -- who tend to receive considerable financial support from drug makers -- have been inclined to accept the industry's arguments that imported drugs pose a safety risk and that higher prices in the United States are necessary so drug manufacturers can funnel the profits back into research and development.

That sentiment appears to be changing. Lawmakers say they now recognize that many Americans are already buying medicines overseas, often through the mail or over the Internet, and that there have been few reports of people being hurt. They say they are also mindful that many voters are fed up with paying more than citizens in nations whose governments control prices. At the same time, as the federal government contemplates spending billions to provide the elderly with prescription drug coverage, even some Republicans say cheaper medicines would save the taxpayers money.

"I just think politically, this is an unsustainable scenario, where the American consumer is shouldering the bulk of research and development costs and corporate profits," said Representative Dave Weldon, a Florida Republican and a doctor who has opposed the legislation in the past but said he would probably vote in favor of it this time. "The drug companies have to come to terms with this."

Even opponents of the measure say they understand their fellow Republicans' frustration, a sentiment shared by many Democrats.

"Obviously, people are distressed over the cost of drugs in this country, and I don't blame them," said Representative Billy Tauzin, a Louisiana Republican who is chairman of the House Energy and Commerce Committee.

But Mr. Tauzin, who is not bound by the leaders' agreement with Mrs. Emerson, said he was pressing lawmakers to vote against the measure, calling it "a disaster to the health and safety of Americans."

The reimportation issue is not new. Similar legislation passed Congress in 2000 and was signed into law by President Clinton, and both the House and Senate included reimportation provisions when they passed Medicare prescription drug legislation last month.

But each of those measures included what Mrs. Emerson calls a "poison pill" -- a requirement that the secretary of health and human services certify that the imported drugs pose "no additional risk" to consumers. Both the Clinton and Bush administrations have refused to do so, preventing the program from taking effect.

As recently as Friday, the federal Food and Drug Administration sent a letter to Mr. Tauzin saying the agency had "serious public health concerns" about drugs imported from foreign sources, saying they may be poorly packaged and stored and are of "unknown quality."

The bill the House will consider this week, whose lead sponsors are Representative Gil Gutknecht, Republican of Minnesota, and Mrs. Emerson, does not include the certification requirement, but would require the F.D.A. to create and institute a system to grant individuals, pharmacists and wholesalers in the United States access to F.D.A.-approved drugs from industrialized nations abroad. The House defeated a similar measure in 2001, but Mr. Tauzin said today that the outcome this time was too close to call.

If the bill passes, it will become the official House position in the Congressional negotiations to reconcile the differences in the House and Senate versions of the prescription drug benefit bill. That is one reason the industry is so nervous about it.

"We're fighting it tooth and nail," said Jeffrey Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, the industry trade group.

The industry has sent armies of lobbyists to the Capitol to persuade lawmakers to oppose the measure and is helping to underwrite a nationwide radio advertising campaign.

The industry trade group has also joined forces with abortion opponents, who recently sent fliers to voters saying the bill would allow Americans easy access to the abortion pill RU-486. The fliers, based on a legal memorandum drafted by the trade group, are sent specifically to conservatives who support the reimportation measure. One shows a baby and states that if the drug importation bill passes, abortion pills "may become as easy to get as aspirin."

But the the mailings, which are sent by the Traditional Values Coalition, a California advocacy group led by the Rev. Louis Sheldon, have backfired, enraging some of the most conservative members of Congress, including Representatives Christopher Smith of New Jersey and Dan Burton of Indiana, both longtime opponents of abortion who support the drug importation bill.

"That is a bogus issue," Mr. Burton said.

Another industry-backed group, the Seniors Coalition, is running radio advertisements. Pfizer, one of the nation's largest drug companies, took out a full-page advertisement in Roll Call, a Capitol Hill newspaper, to publish a letter from its chief executive, Hank McKinnell, who says the proposal threatens the safety of the nation's drug supply.

"The F.D.A. would no longer be able to make sure that medications are stored and shipped safely," Mr. McKinnell wrote.

Drug manufacturers are among the biggest contributors to political campaigns; during the 2002 election cycle, the industry gave nearly $27 million to political candidates, three-quarters of it to Republicans. But one industry lobbyist said the manufacturers now worried that their success in the marketplace had become a political liability in Congress.

"There's this sense on the Hill that the industry is too rich for its own good," the lobbyist said.

For the industry, the financial stakes in the reimportation fight could hardly be greater. The Gutknecht bill estimates that widespread drug importation could reduce average drug prices in the United States by 35 percent and drug spending by $635 million over 10 years. If passed, the bill could wreck the industry's carefully constructed worldwide pricing systems.

Last year, average drug prices in the United States were 67 percent higher than those in Canada and about twice those of Italy and France, according to a report by the Patented Medicine Prices Review Board, a Canadian health agency. The United States spends 1.6 percent of its gross domestic product on drugs, compared with 0.6 percent in Germany and 0.9 percent in Canada, according to the report. The drug industry now gets more than half of its worldwide revenues from American consumers.

Industry executives argue that the proposed Medicare drug benefit will, on its own, help bring drug prices down. But some fear that the House and Senate Medicare negotiations will collapse, leaving the reimportation measure to gather steam.

"There is no reason why anybody should believe that, under a Medicare drug benefit, providers would not get a similar level of discounts," said Daniel Vasella, chief executive of the Swiss pharmaceutical giant Novartis. "Importing from countries with a different drug review and approval process and regulated prices undermines the foundation of the American economy."

Still, many lawmakers are angry at the drug manufacturers. Mrs. Emerson said she was moved to support reimportation by caring for her elderly mother-in-law, who spends as much as $1,200 a month on prescription medicines. Mr. Burton, the congressman from Indiana, frequently refers to his wife's experience taking tamoxifen, the breast cancer drug, which he says costs $360 a month in the United States, compared with $60 a month in Germany.

"Every woman in America ought to be angry as hell at the pharmaceutical industry," Mr. Burton said, "and you can quote me on that."

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