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HHS announces task force on drug importation

WASHINGTON, D.C., February 27, 2004 -- HHS Secretary Tommy G. Thompson announced the creation of a task force to advise and assist HHS in determining how drug importation might be conducted safely and its potential impact, positive and negative, on the health of American patients, medical costs and the development of new medicines.

The new Task Force on Drug Importation has a broad mandate to solicit and combine information from a wide variety of health care stakeholders, including supporters and opponents of importation, to offer recommendations to the Secretary on how best to address the key questions posed by Congress on drug importation. The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) directed the Department of Health and Human Services to lead a comprehensive study of importation.

Secretary Thompson said a fundamental responsibility of HHS, as the nation's health department, is to protect the integrity and safety of the medicines Americans take. The Secretary said the department, under the current and previous administration, has not been able to guarantee the safety of imported drugs, but that the task force will look to identify new solutions that could permit safe importation.

"The importation of drugs remains a long-standing safety concern for the Department of Health and Human Services, as we currently cannot guarantee the safety of these medicines," Secretary Thompson said. "This task force will study what it would take in terms of oversight and resources to safely import drugs. It will hear from all sides of the issue in a public, transparent manner. I'm confident that it will produce a balanced picture of the costs and benefits of drug importation."

In the MMA, Congress directed HHS to complete a study by December 2004 to address the following issues related to drug importation:

  • Identify the limitations, including limitations in resources and in current legal authorities, that may inhibit the Secretary's ability to certify the safety of imported drugs.
  • Assess the pharmaceutical distribution chain and the need for, and feasibility of, modifications in order to assure the safety of imported products.
  • Analyze whether anti-counterfeiting technologies could improve the safety of products in the domestic market as well as those products that may be imported.
  • Estimate the costs borne by entities within the distribution chain to utilize such anti-counterfeiting technologies.
  • Assess the scope, volume and safety of unapproved drugs, including controlled substances, entering the United States via mail shipment.
  • Determine the extent to which foreign health agencies are willing and able to ensure the safety of drugs being exported from their countries to the U.S.
  • Assess the potential short- and long-term impacts on drug prices and prices for consumers associated with importing drugs from Canada and other countries.
  • Assess the impact on drug research and development, and the associated impact on consumers and patients, if importation were permitted.
  • Estimate agency resources, including additional field personnel, needed to adequately inspect the current amount of pharmaceuticals entering the country.
  • Identify the liability protections, if any, that should be in place if importation is permitted for entities within the pharmaceutical distribution chain.
  • Identify ways in which importation could violate U.S. and international intellectual property rights and describe the additional legal protections and agency resources that would be needed to protect those rights.

The task force will be chaired by Mark B. McClellan, M.D., Ph.D., commissioner of HHS' Food and Drug Administration (FDA). It will include representatives from government agencies that may be significantly affected by drug importation and that have significant expertise to contribute: FDA, HHS' Centers for Medicare & Medicaid Services, the Bureau of Customs and Border Protection and the Drug Enforcement Administration. Other federal agencies will be consulted as appropriate.

"This task force provides an important forum for bringing all of the evidence to bear on how the public health risks created by the importation of unapproved drugs might be alleviated, and what the consequences for drug prices and drug innovation would be," Commissioner McClellan said. "It will feature extensive discussion with all stakeholders and the general public of all of the key questions involved, and it will do so in a way that allows for broad public participation."

In order to gather and discuss information from all relevant stakeholders, the task force intends to convene five meetings, one each with representatives from the following groups: consumer groups; professional health care groups; health care purchasers, including representatives of cities and states; industry associations; and international stakeholders. There will also be a meeting for the general public to provide comments.

Additionally, the task force will open a public docket to accept comment from interested parties on issues related to drug importation. To facilitate public discussion, the task force will post a set of preliminary questions about the safety and impact of drug importation. The task force also will publish proceedings from the stakeholder meetings.

Source: FDA Press Office

Posted: February 2004