HHS Creates Task Force to Study Drug Importation

The choice of FDA Commissioner Mark McClellan to head the team sparked immediate controversy. Although the new Task Force on Drug Importation is slated to solicit information from a broad spectrum of supporters and opponents to drug importation – from pharmaceutical manufacturers to drug product consumers – the choice of FDA Commissioner Mark McClellan to head the group has raised cries of foul from many of those in favor of imports. As the head of the FDA, McClellan has made no secret of the fact that he is adamantly opposed to importing drugs, even from countries with relatively safe drug supplies, like Canada. In fact, McClellan reluctantly appeared before Congress in mid-March after repeatedly being asked (and just as often declining) to testify concerning his stance on drug imports. He finally agreed to speak to Congressional members because his historical position on the issue was holding up his confirmation as President Bush's choice to head the Centers for Medicare & Medicaid Services.

In order to gather and discuss information from all relevant stakeholders, HHS has announced that the task force will 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 April 14, announced in the Federal Register of March 18 (see http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-6145.htm), at which the general public is invited to provide comments.

Health and Human Services Secretary Tommy G. Thompson announced on Feb. 26 that a task force had been created to advise and assist HHS in determining whether and how drug importation into the United States could be conducted safely. The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) directed the HHS to lead a comprehensive study to be completed by December 2004, gauging both the positive and negative effects that can be expected on the health of American patients, on medical costs and on the development of new medicines if pharmaceutical products are imported into the United States from countries with lower drug prices.

In the MMA, Congress directed HHS to address, among other things, the current limitations on the ability to certify the safety of imported drugs, the vulnerabilities in pharmaceutical distribution chains that could compromise safety, the availability of anti-counterfeiting technologies and their costs, and the willingness of foreign countries to help ensure the drugs shipped to the United States are safe, genuine and meet FDA standards.

In addition, HHS was asked to assess the long-term effects of drug imports on drug prices and on research and development efforts, aspects of the drug import debate that have largely been ignored by consumers who want lower-cost drugs now. The question is, if U.S. consumers are now footing much of the bill for these costs, who will take up the slack if they start buying from countries that have negotiated better deals for their own citizens? It may be true that some of these other countries are getting a free ride, but if Americans stop paying too, something has surely got to give.

The choice of FDA Commissioner Mark McClellan to head the team sparked immediate controversy. Although the new Task Force on Drug Importation is slated to solicit information from a broad spectrum of supporters and opponents to drug importation – from pharmaceutical manufacturers to drug product consumers – the choice of FDA Commissioner Mark McClellan to head the group has raised cries of foul from many of those in favor of imports. As the head of the FDA, McClellan has made no secret of the fact that he is adamantly opposed to importing drugs, even from countries with relatively safe drug supplies, like Canada. In fact, McClellan reluctantly appeared before Congress in mid-March after repeatedly being asked (and just as often declining) to testify concerning his stance on drug imports. He finally agreed to speak to Congressional members because his historical position on the issue was holding up his confirmation as President Bush's choice to head the Centers for Medicare & Medicaid Services.

In order to gather and discuss information from all relevant stakeholders, HHS has announced that the task force will 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 April 14, announced in the Federal Register of March 18 (see http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/04-6145.htm), at which the general public is invited to provide comments.