Kathleen Sebelius U.S. Secretary of Health and Human Services

“In terms of the drug re-importation, I share your concerns about the recent -- whether it's the Heparin issue from China or other stories that have been done on manufacturing sites which clearly are not being inspected on a regular basis…"

On the Record

“In terms of the drug re-importation, I share your concerns about the recent -- whether it's the Heparin issue from China or other stories that have been done on manufacturing sites which clearly are not being inspected on a regular basis. So while I support, and the president has indicated his support and proposed some budget money to begin to look at re-importation, I think it can only be done if the inspections are accomplished and that we are satisfied that the standards are equivalent or above American standards. And that is going to take some time and some work. The secretary has had the authority from Congress, if deemed safe, to engage in re-importation. As you know, in the past, that has not occurred. And it would be my commitment that that would not occur until I was satisfied, if I am confirmed as secretary, that that safety issue is absolutely met. So I look forward to working with you on that.”

- Response of Kathleen Sebelius, Secretary of Health and Human Services, when asked about the importation of prescription drugs, during her confirmation hearing before the Senate Finance Committee on April 2, 2009.

“I would suggest, at least at this point, that restoring the FDA's competence and capabilities to its previously held gold standard is really step one; that having -- we recently had a situation with heparin coming out of China, we've had melamine, we've had -- which, again, showed up in pet and animal food, not in prescriptions. But there is some evidence that the current challenges are not being well met. But I certainly am one who thinks that we need to take a look at the re-importation, make sure that there are avenues, lots of avenues for Americans to access a lower quality -- I mean, high quality, lower cost prescription drugs, and I look forward to having that dialogue, if confirmed as secretary.”

- Response of Kathleen Sebelius, Secretary of Health and Human Services, when asked about the importation of prescription drugs, during her confirmation hearing before the Senate HELP Committee on March 31, 2009.

Donna Shalala Former U.S. Secretary of Health and Human Services

“…we in the Administration and the Congress have a strong obligation to communicate clearly to the American people the shortcomings in policies that purport to offer relief from the high cost of prescription drugs…"

In 2004, the U.S. Department of Health & Human Services formed a task force to explore how prescription drug importation could potentially impact the health and safety of American patients, medical costs and the development of new medicines.

On the Record

Two U.S. Secretaries of Health and Human Services have testified before Congress and sent letters to lawmakers about the dangerous implications of prescription drug proposals. Read their thoughts below.

“…an importation provision—no matter how well crafted—cannot be a substitute for a voluntary prescription drug benefit provided through the Medicare program.”

- Excerpts of December 26, 2000 letter by Donna Shalala, Secretary of Human Health and Services, to President Clinton explaining her refusal to implement the MEDS Act.

“…the law requires us to certify as Secretary that we know that these drugs are safe. It's impossible for us to certify that these drugs are safe.”

- Response of Tommy Thompson, Secretary of Health and Human Services, when asked about opening U.S. borders for the importation of prescription drugs, during testimony before the Senate Budget Committee on February 14, 2002.

“…I would not be able to do that.”

- Response of Tommy Thompson, Secretary of Human Health and Services, when asked about the possibility, based on the examination of the Canadian regulatory system, of making an exception for imported drugs from Canada, during testimony before the Senate Budget Committee on February 14, 2002.

- Tommy Thompson, Secretary of Human Health and Services, speaking at a biotechnology summit on June 9, 2002.

Thommy Thompson FormerU.S. Secretary of Health and Human Services “Opening our borders to reimported drugs potentially could increase the flow of counterfeit drugs, cheap foreign copies of FDA-approved drugs, expired and contaminated drugs, and drugs stored under inappropriate and unsafe conditions. ”

“Opening our borders as required under this program would increase the likelihood that the shelves of our pharmacies in towns and communities across the nation would include counterfeit drugs, cheap foreign copies of FDA-approved drugs, expired drugs, contaminated drugs, and drugs stored under inappropriate and unsafe conditions.” “I can only conclude that the provisions in the MEDS Act will pose a greater public health risk than we face today and a loss of confidence by Americans in the safety of our drug supply.” “Since I am unable to make the determination on the safety and cost savings in the affirmative, as required under the law, I cannot implement the MEDS Act. - Excerpts of June 9, 2001 letter from Tommy Thompson, Secretary of Human Health and Services, to Senator James Jeffords explaining the Secretary’s inability to implement the MEDS Act, which would allow for the importation of prescription drugs from other countries into the U.S.