Health Biz: Drug importation moves closer

By ELLEN BECK  |  April 19, 2005 at 4:42 PM
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WASHINGTON, April 19 (UPI) -- More signs point to drug-importation legislation making it through this session of Congress -- but it is not a sure thing. Concerns over safety remain among Republicans, even as the political pieces are falling into place for a bill to reach President Bush's desk.

Republicans slowly have moved to support legalized importation, which Democrats latched onto after they lost control of the Medicare prescription-drug movement to President Bush, who now claims the Medicare Modernization Act of 2003 as a domestic-policy centerpiece.

Faced with embarrassment for allowing the Republicans to push through their pet project, Democrats looked over the MMA's shoulder and found rising costs of prescription drugs not only for seniors, but for all Americans.

Buses loaded with seniors heading to Canada to purchase medicine more cheaply, a wide-open Internet touting cheap Viagra and painkillers to anyone with a credit card, and pharmaceutical industry profits ever on the rise made for an acceptable consolation prize for Democrats. Legalizing drug importation from Canada and European countries would bring prices down for everyone, ensure the safety of drugs, reduce problems of drug counterfeiting and unregulated Web pharmacies and, though not imposing true price controls, take Big Pharma down a notch.

At some point in the argument last year, Republicans began to realize Democrats were not backing down and were getting support from seniors who could not afford their prescription drugs.

The GOP throughout 2004 also could not come up with the evidence -- not thousands or hundreds or tens or even a handful of deaths among Canadians who took prescription drugs purchased from Canadian pharmacies. Not to mention those U.S. seniors were suffering no adverse effects from prescriptions they obtained north of the border, either.

The safety issue touted by the administration fell on deaf ears and even Tommy Thompson, then the Health and Human Services Secretary, said Bush should not stand in the way of importation legislation.

The result is S. 334, the Pharmaceutical Market Access and Drug Safety Act of 2005, which has some 30 bi-partisan co-sponsors in the Senate. They include Republicans Charles Grassley of Iowa and Trent Lott of Mississippi, and Democrats Byron Dorgan of North Dakota, Debbie Stabenow of Michigan and Edward Kennedy of Massachusetts.

The companion bill in the House, H.R. 700, introduced by a Republican, Jo Anne Emerson of Missouri, has only eight sponsors but they include fellow Republicans Ginny Brown-Waite of Florida, Anne Northup of Kentucky and Zach Wamp of Tennessee. Independent Bernard Sanders of Vermont also is a co-sponsor, along with Democrats Marion Berry of Arkansas, Dennis Moore of Kansas, Sherrod Brown of Ohio and Thomas Allen of Maine.

Another importation bill on the docket is S. 109, the Pharmaceutical Market Access Act of 2005, introduced by newcomer Republican David Vitter of Louisiana, who championed the bill after winning the seat left vacant with the retirement of Democrat John Breaux. This bill is co-sponsored by fellow freshmen Republicans Jim DeMint of South Carolina and John Thune of South Dakota. On the Democrat list, newcomer Ken Salazer of Colorado also is a co-sponsor. The House companion bill, H.R. 328, also introduced by a Republican, Gil Gutknecht of Minnesota, has 85 co-sponsors from both parties -- including some who also co-sponsored H.R. 700.

These bills are working their way through the committee process -- not necessarily always on their own, but because of political wrangling on other issues. Supporters really are not quibbling as long as one version passes both chambers.

"If their bill was on the Senate floor for passage right now I would enthusiastically speak for it, vote for it," Vitter told the Senate Health, Education, Labor and Pensions or HELP Committee Tuesday during a hearing on Dorgan's S. 334.

Though S. 109 differs from S. 334 in its mechanics, Vitter said, "I stand shoulder to shoulder on the broad issue with all of my colleagues here."

HELP Committee Chairman Mike Enzi, R-Wyo., said the committee "will do something on drug importation" and Dorgan testified, "I believe we have the votes to pass this in the House and the Senate."

Enzi also recently won unanimous Senate approval of a budget bill amendment that would set up a fund for implementing the safe importation of drugs.

Even with Republican and Democrat agreement that drug importation will go through, it does not mean the process will be easy. The Bush administration is not onboard and Tuesday's hearing brought out two trouble spots in supporters' arguments: Food and Drug Administration regulation and parallel trading.

S. 334 spells out how pharmacies and wholesales that would import drugs into the United States would have to be regulated by the Food and Drug Administration -- calling for registration and FDA inspection of non-U.S. facilities.

Sen. Judd Gregg, R-N.H., said the bill replaced long-standing regulations that guarantee the safety of U.S. drugs with a "new regime" and demanded the sponsors explain a section entitled "Manufacturing changes."

Bill co-sponsor Sen. Olympia Snowe, R-Maine, responded that because legal importation would be new to FDA "I'd expect there would be a change in regime."

"These are critical issues to the consumers of America," an irritated Gregg shot back. "What does it mean?"

Gregg than reclaimed his time and did not allow Snowe to finish her answer, but Dorgan tried to smooth things over by saying the bill sets up a closed system where only FDA-approved drugs made in FDA-approved facilities would be imported -- essentially the same process as currently used.

"We don't propose to change any of that," Dorgan said.

"I don't know what that means and the FDA doesn't know what that means," Gregg said. "It's going to have a huge impact on the drugs coming into this country."

The importation supporters' argument, that the European Union system of parallel trading -- when consumers can import drugs from any other member country, e.g., from England to Spain or from Italy to France -- is safe and effective, was shot down by U.K. consultant Graham Satchwell, an expert on pharmaceutical fraud and counterfeit drugs.

Satchwell, author of "A Sick Business - Counterfeit Medicines & Organized Crime," testified the United Kingdom has more parallel trading because it has higher drug prices than other EU countries. He called it a perfect way to smuggle counterfeit products through legitimate channels.

"There is no one European body that a dealer can check to see if the drug has a license or not," Satchwell testified. "Each U.K. trader would have to speak every European language."

Satchwell also said parallel trading means medicines can change hands 20 times in the distribution chain, "making product recall practically impossible."

His written testimony noted a 2004 survey showed of 300 imported medicines examined, 25 percent should have failed on safety reasons and 50 percent because of poor quality of the product.

Dr. David Kessler, a former FDA commissioner and now at the University of California-San Francisco, said the debate in the United States is not about establishing importation because that already is occurring.

"The current system is out of control," he testified, "There is virtually no reliable way for consumers to know if an Internet pharmacy outside the United States is legitimate."

He said S. 334 would "give FDA a way to assess whether drugs distributed in other countries meet FDA standards."

Pharmaceutical Research and Manufacturers of America Executive Vice President Russel Bantham did not testify before the panel, but issued a statement disagreeing with supporters of the bill.

"Unfortunately many of the witnesses at today's HELP Committee hearing failed to give a complete picture of the dangers involved with their legislation," Bantham said. "The Pharmaceutical Market Access and Drug Safety Act of 2005 is nothing but a bait and switch scheme. This bill would allow importing drugs not only from Canada, but from more than 25 other countries, including Latvia, Estonia and Slovakia. According to recent polls, an overwhelming majority of seniors oppose importing drugs from foreign countries other than Canada. Worst yet, the Canadian government has said many times that it takes no responsibility for the origin, safety or effectiveness of medications destined for the U.S."

Kennedy summed up the emotional issue of how double-digit percentage increases in prescription drugs have hurt Americans -- especially seniors. He noted a study published in Health Affairs that found 25 percent of America's seniors went without needed medications because they couldn't afford them.

"We have a real crisis for real people, for real families," Kennedy said "It's the responsibility of Congress to see that it (importation) can be done safely."

The administration's task force on drug importation last year decided such a system would not be safe -- and Bush has not backed away from that assessment. Whether he would veto drug importation legislation is uncertain -- but given the public support for it such a move could have repercussions at the state level for Republican lawmakers.



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