Washington Editor

WASHINGTON - By way of a task force, the Bush administration plans to decide once and for all whether reimporting prescription drugs from foreign countries can be done at an affordable price without compromising safety.

FDA Commissioner Mark McClellan, who might soon leave his current post to take over the Center for Medicare and Medicaid Services, has been tapped by President Bush to lead the task force, which is mandated under the new Medicare law passed Dec. 8.

During a speech before the National Medicare Prescription Drug Congress here Wednesday, McClellan, a physician and economist, said he understands why seniors feel compelled to cross the Canadian border or log on to the Internet to take a chance on finding cheap prescription drugs.

"As a physician, I had patients who could not afford drugs," he said. "Drug affordability is a serious problem, but you can't just assume [imported or Internet] drugs are safe."

The issue of reimporting FDA-approved prescription drugs from other countries has been hanging over Washington for several years. On one side, certain members of congress, such as Sen. Jim Jeffords (I-Vt.) and Rep. Bernie Sanders (I-Vt.), believe it is reasonable to pack seniors in a bus, take them to a Canadian pharmacy and let them buy prescription drugs at a cheaper price. But others, such as McClellan, warn that the practice is illegal and not necessarily safe.

Nevertheless, the Bush administration is willing to take another shot at helping seniors cut costs by considering reimportation. Indeed, the new Medicare law contains a provision that legalizes reimportation from Canada if Tommy Thompson, secretary of Health and Human Services, certifies that it is safe. The Clinton administration approved similar language that required approval from former HHS Secretary Donna Shalala, who refused to sign off on the law. (That does not include biologics.)

McClellan said the reimportation task force will meet five times and plans to hold a public hearing. Reimporting and buying drugs from Internet pharmacies are two practices that have received a lot of coverage over the last few years as legitimate ways of saving a buck. But McClellan said, there are other more obvious ways of saving money - take for example, buying generics. While biologics currently do not fall under generic or Hatch-Waxman regulations, McClellan said the FDA is working on the science for generic biologics. (The Hatch-Waxman Act of 1984 created the generic drug industry.) Generic drugs sold in the U.S. are among the cheapest drugs in the world, McClellan said. But according to his statistics, most states spend 7 percent to 8 percent on innovator or brand-name drugs that have an FDA-approved generic equivalent.

The state of Illinois, for example, had a list of innovator drugs it planned to purchase from Canada, unaware that several were available in the U.S. as generics, McClellan said.

Indeed, part of the new Medicare plan will include an education element to help seniors and others gain a better understanding of coverage and options.

And to ensure that drugs purchased in the U.S. are legitimate, McClellan said the FDA is looking toward tightening rules to secure the drug supply against criminal efforts to introduce counterfeit drugs.

Among the efforts, the FDA will consider improving packaging and securing the movement of a product as it travels through the U.S. drug distribution chain. While the FDA admits the threat of counterfeit drugs is growing, it denies that the problem is widespread in the U.S.

However, David Kelly, a trademark attorney with Finnegan, Henderson, Farabow, Garrett & Dunner in Washington, told BioWorld Today counterfeiting is a real problem, but it's probably under-reported because drug companies don't want to publicize the fact that there could be fake versions of their drugs floating around. He supports the FDA's pledge to reduce the threat by improving packaging and implementing a more sophisticated system of tracking drugs through the distribution system.

Counterfeit drugs are more likely to enter the U.S. through some type of clandestine arrangement, rather than from Canada or the Internet, Kelley said.

The administration's plan to educate the public on new Medicare legislation is probably a good idea, as a Kaiser Family Foundation survey released Thursday said nearly seven in 10 seniors were not aware that Medicare legislation had passed and was signed into law.

As of early February, 64 percent of seniors (vs. 49 percent of the overall public) said they followed the Medicare prescription drug debate "very closely" or "somewhat closely." However, only 15 percent of seniors (vs. 7 percent of the public) said they understand the new law "very well," 24 percent of seniors (vs. 26 percent of the public) say they understand it "somewhat well," and 60 percent of seniors (vs. 64 percent of the public) say they understand it "not too well" or "not well at all," the study said.

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