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PHARMACEUTICAL MARKET ACCESS AND DRUG SAFETY ACT OF 2004
April 21, 2004
I am pleased to join Senators Dorgan, Snowe, Kennedy, Daschle, and others in introducing the Pharmaceutical Market Access and Drug Safety Act of 2004. This bill represents a strong bipartisan compromise, and is designed to establish a system for American consumers to safely import lower cost prescription drugs.
Mr. President, American consumers are frustrated, and for good reason. We pay the highest prices in the world for brand name prescription drugs. Prices continue to rise at double digit rates -- far outpacing inflation. With over 43 million uninsured Americans and millions more seniors without a substantial prescription drug benefit, filling a doctors prescription is unaffordable for many people in this country. Every day, far too many families are forced to make difficult choices between life-sustaining prescription drugs and other daily necessities.
The United States represents the largest pharmaceutical market in the world. Our taxpayers make substantial investments into pharmaceutical research and development. And yet, Americans are still paying 30 to 75 percent more for their prescriptions than consumers in Canada, the European Union, and elsewhere.
In 2000, Congress passed the Medicine Equity and Drug Safety (MEDS) Act to provide Americans with a legal means to obtain lower cost prescription drugs from industrialized countries with prescription drug regulatory systems similar to our own. Yet here we are, four years later, and Americans still cannot legally access lower cost prescription drugs from other nations. The safety certification requirement contained in the MEDS Act proved to be a poison pill. In the bill we are introducing today, we have spelled out the safety measures that will be necessary for an importation program, making the certification requirement unnecessary.
According to recent polls, nearly two thirds of Americans believe the government should make it easier to import lower cost drugs from Canada and other countries. And, Americans have begun to take matters into their own hands. Last year, Americans spent an estimated $1.1 billion on prescription drugs imported from Canada, twice the amount that was spent the previous year. And states are now taking action too.
We also passed an enormous expansion to the Medicare program last year. Unfortunately, that new law largely benefits the pharmaceutical industry and other special interests, and is already slated to cost $534 billion $134 billion more than was estimated just a few months ago. That law, which will burden American taxpayers for generations to come and contributes substantially to the financial insolvency of the Medicare program, did practically nothing to rein in the cost of prescription drugs.
With all of the money the federal government will now be spending on prescription drugs, very little is being done to help reduce their costs. In fact, the Medicare package explicitly prohibits the Secretary of Health and Human Services from engaging in negotiations to lower prescription drug costs. This must change.
In the absence of federal action, states like Minnesota, Illinois, Iowa, Wisconsin, Vermont and New Hampshire, together with cities like Springfield and Boston, Massachusetts, Montgomery, Alabama, and Los Angeles, California, have moved this issue to the forefront. In fact, the City of Springfield recently announced that their drug importation program saved the city more than $2 million in the last nine months alone. Despite these successes, our federal regulators continue to oppose any effort to facilitate importation.
Throughout the debate surrounding prescription drug importation, much concern has been raised regarding consumer safety and the security of the U.S. drug supply, with a particular focus on the dangers of Internet pharmacies and counterfeit drugs. Let me be clear. None of us want American consumers to be harmed from purchasing imported prescription drugs. That is why throughout the development of this package, consumer safety has remained our primary concern. This bill includes a number of measures which will make imported drugs as safe, if not safer, than drugs purchased through the domestic supply chain. With proper government oversight, such as that which would be provided under our legislation, Americans should be able to obtain access to safe lower cost prescription drugs from Canada, the EU and other markets.
Under our proposal, during the first year after enactment, the bill would enable individual American consumers, wholesalers, and pharmacists to import FDA approved prescription drugs from FDA approved and inspected Canadian exporters. Recognizing that the Canadian market is too small to satisfy the American demand, one year after enactment, the bill would allow FDA approved pharmacists and wholesalers to import FDA approved drugs from a larger group of nations, including the European Union, Switzerland, Australia, New Zealand and Japan.
To ensure the safety of this new system, the FDA would be required to regularly inspect Canadian exporters as well as domestic importers. The legislation also would require all importers and exporters to maintain a full chain of custody, or pedigree, for the drugs imported into the U.S.
I want to mention my concerns over actions recently taken by several powerful brand companies. Putting profits before patients, they have limited the supply of pharmaceuticals to Canadian pharmacies and wholesalers who export to the United States. Such a practice is unacceptable. Therefore, our bill seeks to close potential loopholes that would allow companies to game the system and unfairly discriminate against pharmacists or wholesalers.
Prescription drug importation may not be the silver bullet that will make prescriptions more affordable for all Americans, but it is a step in the right direction. At a minimum, Americans deserve fairer prices for the prescription drugs their tax dollars helped to develop.
I have long supported prescription drug importation, and I find it remarkable that our federal regulations still do not give American consumers the right to access the same markets as consumers in other parts of the developed world.
We are under no illusions that this is a perfect bill, however, it does represent a solid, bipartisan compromise. We are committed to continuing to consider ways to technically improve the bill and ensure that the system we are developing is as effective and efficient as possible to provide all American consumers access to more affordable prescription drugs.
We cannot allow election year politics to distract us from passing critical legislation that will substantially benefit the millions of Americans who struggle to afford the high cost of prescription drugs. Despite the challenges of passing this legislation in an election year, we are committed to this effort.
I believe American consumers deserve access to safe and affordable imported prescription drugs. I am committed to working with my colleagues, on both sides of the aisle, to move this issue forward expeditiously and to ensure that our strong bipartisan compromise is enacted this year.
I urge my colleagues to support this measure.
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