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4/21/2004

HHS Task Force Hears Concerns About Importation, Drug Prices

Donna Young

The debate about importation of drug products from foreign countries continues to surge as more and more seniors and other Americans cross the border into Canada to buy medications.

States and city governments are becoming bolder in defying federal law, and a growing group of legislators is seeking to legalize the importation of drugs this year.

Drug products with FDA-approved labeling may be imported into the United States or reimportedproducts made in the United States, exported, and returned into the countryby only the manufacturer.

But as long as Americans continue to pay higher prices than consumers in foreign countries for prescription medications, illegal importation of drugs will continue, said Ben Peck, Washington policy director for the Medicare Rights Center, a nonprofit advocacy organization for seniors and other Medicare beneficiaries.

And as long as drug importation is illegal, "FDA cannot take the steps needed to make this practice safer," he said.

Peck made his comments on March 19 in Rockville, Maryland, before the Department of Health and Human Services (HHS) Task Force on Drug Importation, a 13-member panel led by Surgeon General Richard H. Carmona that is charged with identifying how importation might be implemented safely and its potential impactpositive and negativeon the health of Americans, health care costs, and research and development of new drug products.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, signed into law on December 8, 2003, directed HHS to conduct a comprehensive study on importation, which must be submitted to Congress by December 8, 2004.

Open sessions? The task force scheduled a series of five invitation-only "listening sessions" with consumer-advocacy groups, health care purchasers, professional health care provider organizations, industry and distribution representatives, and international stakeholders to gather and discuss information.

HHS also gave the general public an opportunity in April to air views about importation at a public meeting in Bethesda, Maryland.

The agency is accepting written comments from the public until June 1, 2004.

The listening sessions were originally scheduled to be closed to the public and the media even though a February 26 HHS statement declared that the task force would "hear from all sides of the issue in a public, transparent manner."

But after some news reporters complained, HHS agreedthe night before the first sessionto open the meetings to "pen and pad coverage only." No broadcast news cameras were allowed.

Senator Byron Dorgan (D-North Dakota) scolded HHS Secretary Tommy G. Thompson in a March 25 letter for attempting to hold the task force meetings in private and demanded that the task force should "be working in full public view."

Given Thompson's initial plan to install Mark B. McClellan, the former FDA commissioner and newly appointed administrator of the Centers for Medicare & Medicaid Services (CMS)whom Dorgan called a "full-throttled opponent" of importationas task force chairman, "there is ample skepticism about [the task force's] work and intentions," the North Dakota senator charged.

Thompson announced on February 26 that McClellan would lead the importation task force, but in a March 16 statement he proclaimed Carmona to be the group's leader.

"You were wise to remove the former FDA commissioner as the head of this task force because its work would never have been accepted as fair and objective," Dorgan told Thompson. "Likewise, attempting to hold the task force meetings in secret will engender a great deal of suspicion. It is, therefore, essential that its work be open to full public scrutiny."

Dorgan had imposed a hold on McClellan's Senate confirmation as the CMS chief, but the senator lifted the hold on March 12 after Senate Majority Leader Bill Frist (R-Tennessee) agreed to create a Senate task force that would "expeditiously" develop drug importation legislation that would pass the Senate, said Dorgan's spokesperson Barry E. Piatt.

Consumer groups weigh in. Alison Rein, assistant director of food and health policy for the National Consumers League, told the task force at the first listening session on March 19 that it is an "embarrassment" that Americans must travel to Canada to find affordable medications.

"Drugs that are not affordable are neither safe nor effective, and consumers should not have to sacrifice safety in order to get an affordable drug," she said.

David Certner, director of federal affairs for AARP, said his organization supports reimportation from "licensed Canadian pharmacies and wholesalers, provided certain safety issues are instituted."

"We are confident that drugs purchased from Canada can be as safe as those purchased in the U.S.; however, we also know that supply can be limited to Canada, and thus many have proposed reimportation beyond Canada," he said.

Should importation of drug products be legalized, Certner said, FDA must be provided the authority to certify and ensure the safety of those products.

The agency should require manufacturers of imported products to use tamper-evident packaging and track-and-trace technologies, he added.

Certner also encouraged the task force to examine the safety of pharmaceuticals in the nation's "own drug supply" to protect Americans from counterfeit products.

"The problem of counterfeiting is not one that is confined to imports," declared Peter Lurie, deputy director of Public Citizen's Health Research Group.

FDA has added to the problem of counterfeit drugs in the United States, he charged, because the agency has failed to enforce a regulation that requires secondary wholesalers to maintain and forward to buyers a pedigreea complete history that identifies each prior sale, purchase, and trade of a prescription drug product.

"It is extraordinary to me that in this country if we decide that a drug is somehow adulterated we do not have an adequate system for recalling it because we do not have a pedigree that can track the drug," Lurie said. "If your car turns out to have a nonfunctional airbag and the company is forced to recall that car, they will track you down, no matter if your car is a secondhand or thirdhand or a fourthhand car. However, the same thing cannot be done to drugs, and it is extraordinary that we have allowed such a system as that to exist."

A Minnesota approach. Peter T. Wyckoff, executive director of the Minnesota Senior FederationMetropolitan Region, said that FDA is "encouraging counterfeiting and contaminated drugs" by doing nothing to control the high prices of medications and having poor oversight of secondary wholesalers. "Our current policies are actually harming the health and safety of Americans," he said.

When his organization was founded 31 years ago, Wyckoff said, the top issue for its members was the high cost of prescription drugs.

"That issue has not gone away, unfortunately, in those 31 years," he said.

The Minnesota Senior Federation began in 1995 conducting "drug runs for grandma to Winnipeg, Canada, and pioneered those efforts," Wyckoff said. "There's been an average savings for people going to Canada consistently over those years of 49% on prescription drugs."

Senator Mark Dayton (D-Minnesota), he said, is "now actually funding our drug runs to Canada . . . and we will continue to be supported by his efforts."

Dayton, he added, "is deeply committed to the cost of drugs."

Wyckoff's group teamed with the National Coalition of Consumer Organizations on Aging to establish a program that negotiates drug prices with Canadian pharmacies.

The Minnesota organization, which Wyckoff describes as sitting "on the east side of Lake Wobegon"a fictional town created by radio personality and author Garrison Keilloris "getting calls from all 50 states" about the drug program.

Wyckoff said he believes that "the Canadian drug supply is actually safer than the U.S. drug supply."

"We have not one example on record in the state of Minnesota of any contaminated or counterfeit drug coming from any licensed . . . Canadian pharmacy. Not one example of an inappropriate drug based on a U.S. doctor's prescription."

Members of Wyckoff's organization have had some problems receiving deliveries of drug products ordered from Canadian pharmacies, he said, because FDA and the Customs Department have seized the packages.

He accused the pharmaceutical industry of "trying to shut off" drug supplies from Canada and "putting the greed of pharmaceutical companies ahead of the needs of the American people."

Are drugs affordable? Emergency room physician Georges C. Benjamin, executive director of the American Public Health Association and a former Maryland secretary of health, said that he has "all kinds of war stories" about patients who cannot afford to pay for their medications.

"Unaffordable means unavailable. Unavailable means poor health outcomes. Poor health outcomes mean higher health costs, which we are all trying to reduce," he said.

Benjamin called on the task force to get their "hands around the cost of prescription drugs."

The high cost of drugs in the United States, he said, is "unsustainable."

Benjamin said that, while he is concerned about safety and would support an FDA mandate for manufacturers to adopt technology that protects consumers from counterfeit products, he questioned whether there was "epidemiology that supports" the government's argument that patients who import drugs from Canada or other countries could be exposed to counterfeit drugs.

"Show me the dead or injured patients," he said.