Washington Editor

WASHINGTON - The Senate debate over prescription drug coverage for the elderly took a nasty turn Wednesday when 69 members agreed that FDA-approved drugs could be reimported from Canada and sold here at a lower cost.

But before biotechnology and pharmaceutical companies across the U.S. had the chance to cringe, the Senate weakened the measure by handing it over to Tommy Thompson, secretary of Health and Human Services, in the form of a second amendment.

The first vote was 69-30 in favor of Sen. Byron Dorgan's (D-N.D.) proposal to allow wholesalers, pharmacists and individuals to reimport drugs from Canada. But the second amendment - which commanded a unanimous vote - makes Thompson certify that reimportation of drugs poses no threat to patient safety.

Both amendments were attached to a bill (S.812) introduced by Sens. John McCain (R-Ariz.) and Chuck Schumer (D-N.Y.) to reform the Hatch-Waxman Act of 1984 by closing loopholes that have allowed the drug industry to extend patents. In the next few weeks, the Senate is expected to take up a number of measures aimed at providing affordable prescription drugs for the elderly. (See BioWorld Today, July 17, 2002.)

If the future is anything like the past, the certification amendment could prevent reimportation from ever happening.

Toward the end of the Clinton administration, similar reimportation legislation introduced by Sen. Jim Jeffords (then a Republican from Vermont, now an Independent) was passed and signed into law. However, when it came time to implement it, Donna Shalala, then secretary of HHS, refused to clear it, saying she could not certify the plan was safe or would reduce drug costs. (See BioWorld Today Oct. 2, 2000, and Dec. 29, 2000.)

Later, when it fell on Thompson's desk, he, too, wouldn't implement it.

Sharon Cohen, vice president for government relations at the Washington-based Biotechnology Industry Organization (BIO), told BioWorld Today that she's not surprised reimportation legislation has passed the Senate again. "It would be better had it not passed at all, but at least there's a stop-gap that says this doesn't happen unless [Thompson] says it is safe," she said.

Jeff Trewhitt, spokesman for the Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA), said, "It's very revealing that previous reimportation legislation passed by Congress was never implemented because two HHS secretaries - one Democrat and one Republican - declined to certify the safety of the practice."

Trewhitt told BioWorld Today the amendment would risk patients' lives. "This is not the way to resolve the pharmaceutical access problems of elderly people," he said. "The practical solution is for Congress to reach a bipartisan agreement on drug coverage under a reformed Medicare program."

In a prepared statement, Trewhitt's boss, Alan Homer, president of PhRMA, referred to the reimportation legislation as a "gimmick," calling it a "misguided attempt to save American consumers money."

And while both amendments are simply added to the broader McCain-Schumer bill, Cohen said it looks like it will pass the Senate.

"The seniors want drug coverage, but unfortunately the Democratic leadership has decided to make this about amending patents," Cohen said. "What that has to do with prescription drug coverage is curious."

She said BIO continues to receive letters opposing McCain-Schumer from state biotechnology associations. "We've received letters from Massachusetts, Maryland, Virginia, California - I could go on and on about the range of state associations that weighed in on this and have said the underlying bill is a bad bill," she said. "This is negative to the biotechnology industry, particularly in those states with high biotech concentrations. But those senators, unfortunately, are largely supporting the measure, and that's a bit of an outrage."