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5/24/2004

ASHP's Scheckelhoff Testifies Before HHS Importation Task Force

Donna Young

Douglas J. Scheckelhoff, director of pharmacy practice managers for the American Society of Health-System Pharmacists (ASHP), testified on May 14 before the Department of Health and Human Services (HHS) Task Force on Drug Importation at a "listening session" in Rockville, Maryland.

Scheckelhoff told the task force that ASHP's House of Delegates will vote in June to reaffirm the Society's policy to "oppose importation of pharmaceuticals except in cases in which the Food and Drug Administration determines it would be necessary for the health and welfare of United States citizens."

The task force is charged with identifying how importation might be implemented safely and its potential impact on the health of Americans, health care costs, and research and development of new drug products.

The 13-member panel held a series of invitation-only listening sessions with consumer-advocacy groups, health care purchasers, professional health care provider organizations, industry and distribution representatives, international stakeholders, and economic experts to gather and discuss information. The task force also held a public hearing on April 14, during which Gary Stein, ASHP's director of federal regulatory affairs, testified.

The following is Scheckelhoff's testimony:

The American Society of Health-System Pharmacists has a long history of advocating Congress and federal agencies about the importance of maintaining the integrity of our nation's drug distribution system.

For more than 50 years, the U.S. could boast the safest, most tightly regulated system for approving and distributing prescription drugs. Today, however, there are challenges facing our system. A growing illegal drug trade, including counterfeit medications, rogue Internet sites, and efforts to open U.S. markets to medications imported from abroad have all raised questions regarding the FDA's ability to respond to those challenges.

Impact of Unapproved Drugs: Pharmacists who work in hospitals are confronted with the issue of purchasing quality pharmaceuticals at the lowest cost on a daily basis. ASHP receives phone calls from pharmacy directors whose hospital administrators have asked them to purchase drugs from Canada at lower prices, rather than from U.S. sources. ASHP has referred them to FDA regulations that prohibit that kind of importation, but the pressure to find lower cost alternate sources remains.

The scope and volume of unapproved drugs entering the United States has raised the concern of ASHP members. That is why ASHP's House of Delegates will vote next month to reaffirm the following policy:

To oppose importation of pharmaceuticals except in cases in which the Food and Drug Administration determines it would be necessary for the health and welfare of United States citizens.

The issue of the safety of our nation's drug supply is being obscured by the issue of allowing individual citizens to purchase prescription drugs at lower prices from non-U.S. locations. While there are no hard data to indicate serious patient harm caused by imported drugs—and it may take years to identify clusters of problems caused by imported medications—the safety perspective must be the highest priority.

There is another factor of the importation issue that has not been addressed adequately, and it relates to foreign terrorism and our nation's counterterrorism activities. The integrity of the drug supply and the health of consumers is at significant risk if terrorists utilize more lenient importation rules to introduce harmful agents into the United States.

  • FDA's Ability to Assure Safety: The FDA's regulatory system has been the world's "gold standard" of drug approval. To assure the safety of imported products, the FDA will need significantly greater resources to examine those products for quality, purity, safety, and effectiveness. Since a significant amount of imported drugs are ordered via the Internet, the agency should consider ensuring the adequate regulation of Internet pharmacy sites.

  • Regulatory/Legislative Issues: The FDA must have the authority to assure the same level of safety for imported drugs as consumers expect from drugs purchased at a state-licensed pharmacy. Consumers are ill-equipped to make these types of risk-benefit decisions. There is no added level of risk beyond today's safety standards that ASHP members would consider acceptable.

  • Technology: The FDA's efforts to encourage manufacturers to include electronic track-and-trace technology into their product packaging for anticounterfeiting measures should work as well to prevent the importation of unapproved drugs, counterfeited products, and prevent reintroduction of diverted drugs. Other anticounterfeiting technologies improve safety, but will have far less impact than an effective track-and-trace system.

  • Financial Impact: The FDA must thoroughly study the financial impact of importation to determine whether it would actually lower the cost of drugs for American consumers. Regulations put into place to implement section 1121 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 must not be burdensome to pharmacists and wholesalers. If pharmacists or wholesalers are required to conduct testing and authentication of imported drugs, the additional costs of doing so would largely eliminate the anticipated cost savings for consumers.

ASHP appreciates the opportunity to comment to the FDA on this significant issue. We are ready to assist the Department of Health and Human Services in any way in developing its policies relating to the importation of prescription drugs. Thank you.