Skip to main content Back to Top

4/21/2004

ASHP's Stein Testifies Before HHS Importation Panel

Donna Young

Gary Stein, director of federal regulatory affairs for the American Society of Health-System Pharmacists (ASHP), testified before the Department of Health and Human Services (HHS) Task Force on Drug Importation at a public hearing in Bethesda, Maryland, on April 14.

Stein 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 is also holding a series of 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.

The following is Stein's testimony:

The American Society of Health-System Pharmacists (ASHP) 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, there are challenges facing that system. A growing illegal drug trade, including counterfeit medications, rogue Internet sites, and efforts to open US markets to medications imported from abroad have all raised questions regarding the FDA's ability to respond to those challenges. In particular, the issue of the safety of the drug supply is being obscured by the issue of allowing individual citizens to purchase prescription drugs at lower prices from overseas locations.

Impact of Unapproved Drugs: You might wonder how pharmacists who work in hospitals would have to confront this issue. I can assure you that I have received phone calls from pharmacy directors whose hospital administrators have asked them to purchase cheaper drugs from Canada, rather than from U.S. sources. I have always referred them to FDA regulations that prohibit that kind of importation. 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 this June 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.

There is another factor of the importation issue that has not been addressed adequately, and it relates to foreign terrorism and our nation's counter-terrorism 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. Is this not being considered a priority because it has not happened yet? Do we have to wait for something to happen?

  • 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 more 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. There should be no added level of risk that ASHP's members would consider acceptable.

  • Technology: The FDA's efforts to encourage manufacturers to include track and trace technology into their product packaging for anti-counterfeiting measures should work as well to prevent the importation of unapproved or counterfeited drug products.

  • 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 are required to conduct testing and authentication of imported drugs, the majority of our membership would not be able to meet these requirements and still have cost-savings to pass on to the American consumer.

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.