Task Force on Drug Importation Created

March 17, 2004 (PLANSPONSOR.com)-A new Task Force on Drug Importation, composed of 13 people named by Health and Human Services (HHS) Secretary Tommy G. Thompson, has been created to explore how drug importation might be conducted safely and to evaluate the potential impact on the country.

The 13 people have been chosen from HHS, as well as from other parts of the federal government, and all have knowledge of or involvement in drug importation issues.

The task force will be chaired by Surgeon General Richard H. Carmona, and the remaining task force members are:

  • Jayson P. Ahern, assistant commissioner in the Office of Field Operations, U.S. Customs and Border Protection, Department of Homeland Security.
  • Alex M. Azar II, HHS general counsel
  • Josefina Carbonell, HHS assistant secretary for aging
  • Lester M. Crawford, DVM, Ph.D., FDA deputy commissioner
  • Betty James Duke, administrator for HHS’ Health Resources and Services Administration
  • Mark B. McClellan, M.D., Ph.D., incoming administrator for HHS’ Centers for Medicare & Medicaid Services
  • Mike O’Grady, HHS’ assistant secretary for planning and evaluation
  • William Raub, HHS’ deputy assistant secretary for public health emergency preparedness
  • Tom Riley, public health branch chief at the White House Office of Management and Budget
  • Amit K. Sachdev, acting FDA deputy commissioner for policy
  • Elizabeth A. Willis, chief of the Drug Operations Section, Office of Diversion Control, U.S. Drug Enforcement Administration
  • Colette Winston, a trial attorney at the Department of Justice

The task force will hold five listening sessions with groups and individuals who would be affected by drug importation: Friday, March 19, April 2, April 28, May 6, and May 14. There will also be a public hearing on April 14.

Under the Medicare Prescription Drug, Improvement and Modernization Act of 2003, HHS is required to complete a year-long study of how a safe program could be put together to reimport less expensive prescription drugs from Canada (see Bush Administration Unveils Drug Reimport Study). The task force will offer recommendations to Secretary Thompson addressing questions raised by Congress.

The government says the issues to be addressed include:

  • 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.