Service Members Home Ownership Tax Act Of 2009--Resumed

Floor Speech

SERVICE MEMBERS HOME OWNERSHIP TAX ACT OF 2009--Resumed -- (Senate - December 15, 2009)

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Mr. ROBERTS. Mr. President, I rise today to talk about prescription drug importation and patient safety. Senator Dorgan's amendment to allow for the importation of prescription drugs into the United States could have grave consequences for patient safety in America.

In a recent letter to my good friend and home State colleague Senator Brownback, the Commissioner of the Food and Drug Administration, Dr. Margaret Hamburg, identified the four risks to patient safety that drug importation schemes pose: No. 1, the drug may not be safe or effective; No. 2, the drug may not be a consistently made, high quality product; No. 3, the drug may not be substitutable with an FDA-approved product; and No. 4, the drug may be contaminated or counterfeit.

That is a lot of risk to expose already-vulnerable patients to. And think about this: Malta. Cyprus. Latvia. Estonia. Slovakia. Greece. Hungary. Romania. These are just a few of the countries that could be exporting prescription drugs to the United States if the Dorgan amendment passes. As a former chairman of the Senate Intelligence Committee, I have grave concerns about the ability of these countries to adequately protect their drug supplies.

Our Food and Drug Administration, the FDA, is the gold standard for drug and product safety in the world, and even it has not been one hundred percent effective in preventing contaminated and counterfeit products from entering our supply chain. The recent scandals involving imported heparin, infant formula, and toothpaste have demonstrated the unfortunate limitations of the FDA's ability to conduct foreign inspections of food, drugs and cosmetics manufacturers abroad. If our own safety watchdog can't guarantee our protection, how can we expect that protection from Malta or Slovakia?

There is a real risk that these countries will be vulnerable to importing drugs from countries that are known for high rates of counterfeiting. In the European Union last year, 34 million counterfeit drugs were seized at border crossings in just 2 months. The World Health Organization estimates that drug counterfeiting rates in Africa and parts of Asia and Latin America are 30 percent or more. And up to 50 percent of medicines purchased from Internet sites that conceal their address are found to be counterfeit. Do we really want an HIV or cancer patient in Ohio, or Arizona or Kansas to rely on imported medicines that may have zero effectiveness, or which may even be harmful?

According to FDA Commissioner Hamburg, the Dorgan amendment does not adequately address these potential risks. In fact, the Commissioner says that the amendment ``would be logistically challenging to implement and resource intensive'' and that ``significant safety concerns ..... and safety issues'' remain.

Senator Lautenberg has introduced a side-by-side amendment to Senator Dorgan's, requiring that, before any law allowing the importation of prescription drugs into the United States can become effective, the Secretary of Health and Human Services must certify that such a scheme will both pose no additional risk to the public's health and safety, AND result in a significant reduction in costs for consumers.

I think that this amendment just makes sense. We must protect the prescription drug supply in America.

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