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The Savings and Safety of Drug Importation

Type: Get Mad Column
Date: Spring 2009
Related Topics: Drug Development, Drug Safety, Policy
The president and Congress are embarking on a fervent campaign to reform our damaged health care system. Few would disagree that there is waste in our current system, and even fewer would disagree with the fact that we need to bring healthcare to the 46 million Americans who are currently uninsured. But, many in Washington and across the country disagree on how to go about financing the massive health care overhaul that lawmakers are now proposing.

The president and Congress are embarking on a fervent campaign to reform our damaged health care system. Few would disagree that there is waste in our current system, and even fewer would disagree with the fact that we need to bring healthcare to the 46 million Americans who are currently uninsured. But, many in Washington and across the country disagree on how to go about financing the massive health care overhaul that lawmakers are now proposing.

Finding Ways to Save

Senators Byron Dorgan (D-North Dakota), John McCain (R-Arizona), and Olympia Snowe (R-Maine) recently introduced the “Pharmaceutical Market Access and Drug Safety Act.” This bill would allow U.S. pharmacies and drug wholesalers to import medications from Canada, Europe, Australia, New Zealand, and Japan. A major motivation for this bill is the potential savings—these senators have said that the bill would save the U.S. $50 billion over a 10-year period, including $10 billion in savings for the U.S. government.

President Obama also supports this approach and in his current budget proposal for fiscal year 2010 expresses that this policy should be implemented as one way to start reducing health care costs. He and others in the administration plan for these savings to be used in part to pay for the expansion of medical coverage for the millions of uninsured Americans.

Concerns for Safety

Saving $50 billion does sound like a tremendous step in the right direction, but what seems to be only discussed among opponents of the legislation are the potential problems drug importation can present for patient safety. The U.S. Food and Drug Administration (FDA) regulates only the American pharmaceutical market—not foreign markets. It does inspect foreign manufacturing facilities, but at an alarmingly low rate due to funding and personnel limitations.

FDA officials have stated on numerous occasions that when pharmaceuticals come into the U.S. from foreign sources, it is not able to guarantee their safety. Last year, the Government Accountability Office reported that despite the fact that serious violations are often found in foreign plants, FDA inspections of those plants occur only every 13 years or so—compared to 2.7 years for U.S. facilities.

Drug importation could also open U.S. borders to an increasing flow of counterfeit drugs. The FDA has also been vocal in expressing concern over the authenticity and safety of these imported drugs. Even without this potential legalization of prescription drug importation, the FDA already battles to keep counterfeit drugs out of the country. Reports have shown that some Canadian pharmacies are shipping drugs from all over the world, so even though consumers may assume the drugs they ordered are from Canada, they may in fact have originated elsewhere. One investigation conducted by the FDA in 2005, found that 85% of the drugs they confiscated were promoted as Canadian products but actually came from more than 27 different countries.

Officials from Canada—one of the countries included in the “Pharmaceutical Market Access and Drug Safety Act”—have stated that they cannot be responsible for the safety of products exported to U.S. customers. While Canada does regulate its domestic supply, it does not regulate exported drugs. Moreover, many Canadian pharmacies on the Internet require customers to sign a waiver absolving the pharmacies of any liability. States and local municipalities that promote importation to their citizens or employees also disclaim any responsibility for safety.

What You Can Do

Now is the time to have your voice heard. While the president and Congress are moving forward a comprehensive plan for health care reform, they have not yet reached a consensus on many of the details. Congress expects to finalize its plan by July.

The Alliance for Aging Research is working with other organizations to ensure that policy changes under consideration also meet the needs of older Americans. Contact your Congressperson and let them know that you too support health care reform that achieves efficiency and provides coverage for more Americans, but that it should be done in such a way that it protects patient safety.

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