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5/19/2004

HHS Holds Final Session on Drug Importation

Kate Traynor

During the Health and Human Services Department's (HHS) sixth and final listening session on drug importation, held on May 14, U.S. Surgeon General and task force Chairman Richard H. Carmona hinted that a strategy for safely importing drugs into the United States has not yet been found.

"At this point, we're considering everything," Carmona told panelists who were invited to speak before the task force. "The door's open."

The importation of prescription drugs by consumers for personal use is illegal but has been tolerated by the Food and Drug Administration (FDA). The task force is studying personal importation by consumers as well as controlled importation by wholesalers and others, which is also currently illegal in this country. Ultimately, the task force will report to HHS Secretary Tommy G. Thompson on whether prescription drugs can be safely imported into this country for use by consumers.

FDA Acting Commissioner Lester Crawford, a member of the task force, summed up his agency's frustration with the current patchwork system of illegal cross-border and Internet importation:

"The utilization of the current nonsystem of people and countries and companies bent on getting the product here at all costs is something that, I have to tell you, is a major concern of ours," he said.

Since its creation in March, the task force has heard from 101 invited participants as well as others who have submitted comments through a public docket, according to a written statement from Carmona. Additional comments can be submitted to the docket until June 1.

During the May 14 session, National Association of Boards of Pharmacy Executive Director Carmen A. Catizone gave the task force a grim assessment of the eventual effects of drug importation as it currently occurs in the United States:

"If illegal importation is allowed to continue, the impact on patient safety, pharmacy practice, and the regulation of pharmacy will be devastating," Catizone said. "The extension of importation to countries lacking effective drug approval processes, regulatory systems, or practice standards will further the erosion and destruction of the entire regulatory system for the practice of pharmacy."

When pressed by the task force for clarification of how importation affects pharmacy regulation, Catizone described the systems being established by some states and local governments to encourage residents to illegally purchase drugs from Canadian pharmacies.

"Once a decision is made that you don't need to follow state regulation and that the governor or other public officials, based on economic reasons, can decide which laws to follow and which not, there is no need for a state board of pharmacy or state regulation," Catizone said. "The governors or other public officials can simply decide based upon what's best for the economic structure of the state."

Also speaking before the task force was Douglas J. Sheckelhoff, director of ASHP's Section of Pharmacy Practice Managers. Scheckelhoff said that the Society opposes drug importation "except in cases in which the Food and Drug Administration determines it would be necessary for the health and welfare of United States citizens."

Scheckelhoff and other presenters stressed the difficulty of ensuring the safety of medications produced without FDA oversight.

"FDA's regulatory system has been the world's gold standard of drug approval," Scheckelhoff said. He added that this country has "the safest, most tightly regulated system for approving and distributing prescription drugs" but that the system is now at risk from the "growing illegal drug trade."

But task force member William F. Raub, deputy assistant secretary for public health emergency preparedness at HHS, noted that the American public does not seem worried about the safety of imported drugs.

"It is a dilemma for this task force that our citizens can look across the border to Canada or across the ocean to the U.K. and see people able to acquire safe and effective medications...at a substantial reduction in price," Raub said.

In general, the professional groups that addressed the task force agreed that drug importation might be done safely if FDA and other federal agencies have substantial involvement in the process.

"Whatever we bring in we need to make sure it meets our existing standards, so that patients can understand that it is safe and physicians can know that it's safe when they write that prescription," said American Medical Association representative Rebecca J. Patchin.

The panelists generally preferred creating a closed, commercial system of importation instead of legalizing the personal importation of drugs.

"Limiting a system to a commercial importation helps with some of this challenge, because you at least use the distribution systems that are present for the United States," said Susan Winckler, vice president for policy and communications for the American Pharmacists Association.

But the degree of oversight recommended by the panelists would require what Patchin described as "significant federal resources" in money and manpower.

"What we're talking about here is developing an adjunct or additive regulatory investigative oversight authority complementary to FDA, to customs, to [the Drug Enforcement Agency], to be able to do their jobs in a broader fashion than they do now, which incurs a huge cost," said Carmona. "All this is, really, is a shell game. We're shifting the cost over here, and ultimately the government then is subsidizing this, either directly or indirectly."

Several panelists pointed out that importation is a side issue to the real problem confronting American consumers—the exorbitantly high prices for medications that can be bought for less anywhere else in the world.

"We're talking about importing the drug, when it appears that what some people want to do is import the price control," Winckler said. "If that's what you want to do, please talk about that and have that discussion....That would at least seem to be an intellectually honest conversation rather than this proxy of 'Let's import the drugs.' "