Remarks as prepared; not a transcript

Vice Admiral Richard H. Carmona, M.D., M.P.H., F.A.C.S.
United States Surgeon General
Department of Health and Human Services

Thank you all for being here. I am Dr. Richard Carmona, the U.S. Surgeon General.

I would like to welcome you all to the first listening session of the Task Force on Drug Importation. On behalf of Secretary Thompson, I want to thank the members of the task force for your willingness to work on this important issue.

Secretary Thompson formed this task force to explore how drug importation might be conducted safely and its potential impact on the health of American patients, medical costs, and the development of new medicines.

I want to thank the Secretary for the opportunity to serve as chair of this task force. Prescription drug safety is an important public health issue, and I look forward to working with all of you as we conduct an objective evaluation based on scientific evidence.

As a trauma surgeon, the former CEO of a health system, and now doctor to the American people, I understand the critical role that prescription drugs have in our public health system. The miracles of modern medicine are often found in a pill. It’s truly wonderful that science has brought us medications that can unclog arteries, lower blood pressure, cure infection, and save and enhance life.

Millions of Americans have come to depend on prescription drugs to keep them healthy. The biomedical research that has led to the development of these drugs is truly awesome.

The new bipartisan Medicare law marks a historic step to lower seniors’ costs for their prescription drugs — actually providing them with health care coverage for these medicines.

Yet we all recognize the interest in other possible ways we can lower the cost of prescription drugs for those who need them, including importation. That is the reason for this task force and these listening sessions.

A good place to begin our work is with some background on the law regarding drug importation. Drug importation is illegal in the United States. On April 22, 1988, President Reagan signed the Prescription Drug Manufacturing Act to ensure that prescription drug products on sale here in the United States would be safe and effective, while avoiding an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs would have on the American public.

Congress decided that legislation was necessary because there were insufficient safeguards in the prescription drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs. Congress also determined that a wholesale drug diversion submarket had developed that prevented effective control over, or even routine knowledge of, the true sources of the medications.

Each subsequent administration has reviewed the potential drug importation process and determined that there is no means to import prescription drugs into the United States that adequately protects the health of the American people.

In fact, in December 2000, Secretary Shalala sent a letter to President Clinton that said that the drug importation law passed by Congress in October of that year, "could pose unnecessary public health risks." Consequently, that administration was unable to permit the sale of imported drugs.

The current administration has also been unable to certify the safety of imported drugs, having found disturbing evidence of unsafe drugs from other countries making their way into American consumers’ homes.

As recently as this January, the Food and Drug Administration and the U.S. Customs and Border Protection reported their examination of 1,982 parcels that appeared to contain drug products. They found 1,728 unapproved drugs, including so-called "foreign versions" of FDA-approved drugs, recalled drugs, drugs requiring special storage conditions, mislabeled drugs, and drugs containing addictive controlled substances. Inspectors found that from 70 to 90 percent of these parcels that they examined in 2003 contained illegal, unapproved drugs.

The negative effects of these unsafe drugs are not always apparent. For example, if a patient has a heart condition and takes mislabeled or subpotent prescription drugs, his death isn’t attributed to the poor medication, it may be attributed to just his heart condition. To date, we know of no way to track the full impact that faulty imported drugs has had on the health of our citizens. But common sense tells us that if people are taking mislabeled, inaccurate, or subpotent medications, there is a clear risk to their health.

What the American people must understand is that the U.S. government cannot ensure the safety and efficacy of medicines that are purchased through this current clandestine system. Purchasing and using prescription drugs that are not produced and distributed under the strict safety guidelines of the FDA is a potential threat to Americans’ health and well-being.

So can importation be done in a safe and effective manner? The foundation of this task force’s work will focus on safety and public health issues of drug importation.

We will research and explore whether prescription drug importation can be done safely and effectively. And if so, what resources are needed to do so. For our work to be valuable to the American people, we must determine whether there is a safe structure for prescription drug importation.

In fact, the Medicare Prescription Drug, Improvement and Modernization Act of 2003 requires us at a minimum to address the following:

1. 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.
2. Assess the pharmaceutical distribution chain and the need for, and feasibility of, modifications in order to assure the safety of imported products.
3. Analyze whether anti-counterfeiting technologies could improve the safety of products in the domestic market as well as those products that may be imported.
4. Estimate the costs borne by entities within the distribution chain to utilize such anti-counterfeiting technologies.
5. Assess the scope, volume and safety of unapproved drugs, including controlled substances, entering the United States via mail shipment.
6. 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.
7. Assess the potential short- and long-term impacts on drug prices and prices for consumers associated with importing drugs from Canada and other countries.
8. Assess the impact on drug research and development, and the associated impact on consumers and patients, if importation were permitted.
9. Estimate agency resources, including additional field personnel, needed to adequately inspect the current amount of pharmaceuticals entering the country.
10. Identify the liability protections, if any, that should be in place if importation is permitted for entities within the pharmaceutical distribution chain.
     
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11. 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.

Undoubtedly there will be challenges in our endeavor. In fact, today we start with many more questions than we have answers. We start with more beliefs about what is possible than facts about what is possible. I’m hopeful that some of the answers — or leads on answers — will come from our presenters today and in the meetings that follow.

I promise to all of the presenters today and in the future listening sessions, the opportunity to be heard. I expect this process to be completely transparent, with frank, open, and honest discussion about the health implications of drug importation.

I also know that there will be diverse ideas presented, and I ask everyone to be respectful of that diversity.

Let me be clear: the mission of this task force, and the purpose of these listening sessions, is not to debate drug importation. Those debates are the purview of Congress.

The role of the Surgeon General is to promote and protect the health of the American people, and to take the best scientific information and present it in a clear and understandable way to the American public and our leadership.

Accordingly, this task force is about the facts and the science. And we will go as far as the facts and the science lead us.

I thank everyone, in advance, for keeping this in mind. These listening sessions will be conducted in an organized manner, in an effort to produce the best information possible.

Each presenter will have up to 5 minutes for opening remarks. After all presenters on a panel have concluded their opening remarks, the task force members may follow up with some questions.

I ask each presenter to be mindful of the time that so that we can ensure that everyone has an equal opportunity to be heard. In addition, the task force will welcome all written and supporting materials that parties would like to submit.

That information, along with the transcript of each listening session, will be available to the public.

Today is the first of six listening sessions, including an April 14 session open to the public. In addition to the listening sessions, the task force and the Department will engage in our own research on the safety of importation. We will present the evidence and information we have gathered through all means to Secretary Thompson and other policymakers for their review and ultimate decision.

I recognize that the eyes of the nation are on this task force and it is my goal and duty to ensure that these meetings are conducted in a manner in which our findings, based on the best scientific evidence, will inspire the full faith and confidence of the American people.

So without further ado, let’s roll up our sleeves and go to work. I would like to introduce and welcome our task force members.

• Mr. Ahern, assistant commissioner in the Office of Field Operations, U.S. Customs and Border Protection, Department of Homeland Security;
• Mr. Azar, HHS general counsel;
• Dr. Carbonell, HHS assistant secretary for aging;
• Dr. Crawford, FDA deputy commissioner;
• Dr. Duke, administrator of HHS’ Health Resources Services Administration;
• Dr. McClellan, incoming administrator for HHS’ Centers for Medicare & Medicaid Services;
• Mr. O’Grady, HHS assistant secretary for planning and evaluation;
• Mr. Raub, HHS deputy assistant secretary for public health emergency preparedness;
• Mr. Reilly, public health branch chief at the White House Office of Management and Budget;
• Mr. Sachdev, acting FDA deputy commissioner for policy;
• Ms. Willis, chief of the Drug Operations Section, Office of Diversion Control, U.S. Drug Enforcement Administration;
  
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• Ms. Winston, trial attorney at the Department of Justice.

Thank you all for your service on this important task force.

Now, let’s begin with our first panel of presenters.

Last Revised: April 27, 2004

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