Senators Threaten to Stall Nomination

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Senators Threaten to Stall Nomination

by Ceci Connolly, the Washington Post

February 25, 2004

Sens. John McCain (R-Ariz.) and Byron L. Dorgan (D-N.D.) threatened yesterday to hold up the nomination of Mark McClellan to run the federal Medicare program because they are frustrated by his refusal as commissioner of the Food and Drug Administration to permit importation of lower-cost medicines from Canada .

Speaking to governors at a meeting on Capitol Hill, McCain said the pair will stall McClellan's nomination to be administrator of the Centers for Medicare and Medicaid Services "until there's a full and complete explanation of why he will not make prescription drugs from Canada available to Americans." He and congressional allies also intend to use parliamentary maneuvers to force votes in the Senate on the volatile issue, he said.

Also yesterday, Wisconsin Gov. Jim Doyle (D) announced that his state -- in defiance of the FDA -- will launch an Internet site this week to steer residents to a limited number of Canadian mail-order pharmacies that Wisconsin officials deem safe and reliable.

At a separate meeting, FDA Associate Commissioner Peter Pitts said the agency has no intention of backing off its aggressive pursuit of cities and states that promote illegal drug importation. "We're not going to go away," he said.

The verbal volleys came on a day of dueling publicity events over whether Americans should be able to shop for medicines in Canada and other countries, where prices are often 30 percent to 80 percent less than in the United States .

First, proponents of drug importation scheduled a late afternoon "summit" with governors and members of Congress. But before they even convened, opponents called a lunch hour session to oppose the growing practice.

"We did not feel that that was going to be a fully balanced and fair presentation of what's happening with importation, the problems that we're facing," said co-sponsor Merrill Matthews, of the Institute for Policy Innovation, a think tank. "And so we decided we were going to bring together this event to try to give you a different picture of what's happening with some of the experts."

The battle has been brewing for months but became especially contentious when Republicans drafting the new law providing prescription drug coverage under Medicare eliminated a provision that would have made drug importation legal. None of the lawmakers expressed reservations yesterday about McClellan's qualifications for the new post -- he has been confirmed by the Senate twice previously for other posts -- but they see his upcoming nomination hearings as leverage on the drug importation issue.

Little new information came out of the four hours of wrangling; much of the sniping centered on who refused to attend which meeting.

Dorgan excoriated FDA officials for skipping the hearing on Capitol Hill and instead sending "a representative to another group putting together some friendly circumstance to describe what they are doing."

Pitts said the invitation was sent to McClellan and he had a scheduling conflict. The FDA did request time to address the full National Governors Association meeting, Pitts countered. That request came too late to change the agenda, according to the association's staff.

While the rhetoric flies in Washington , thousands of Americans continue to illegally import drugs from other countries. IMS Health, a medical research firm based outside Philadelphia , estimates Americans spent $1 billion on drugs bought from Canada last year.

When the practice was limited to handfuls of senior citizens taking buses across the border, the FDA looked the other way. But in recent months, regulators have become alarmed by mayors and governors who see Canadian imports as a way to save money.

"When you remove the learned intermediary -- the doctor or the pharmacist -- and replace them with a greedy intermediary -- a storefront drug dealer, an unregulated out-of-control Internet pharmacy site -- all bets are off," Pitts said. "Profiteers masquerading as pharmacists bode poorly for both safety and effectiveness."

When Minnesota Gov. Tim Pawlenty (R) created a state Web site endorsing two Canadian mail-order pharmacies, the FDA accused the state of assisting "those who put profits before patient health," but it has not taken any enforcement action to date.

In a four-page letter, the FDA outlined "egregious violations of good pharmacy practices" at the Canadian firms inspected by Minnesota officials. The list included technicians doing the work of pharmacists, failing to check patients' allergies, improper storage of medicines, poor record-keeping and faulty labeling.

Leslie Kupchella, a spokeswoman for the governor, said the violations detailed by FDA occurred in pharmacies that the state chose not to endorse.

Told that Pawlenty planned to keep the Web site up, Pitts said: "We'll go back at him."