Drug Reimportation Bill Called ‘Risky’

Published September 1, 2003

The idea of letting Americans buy prescription drugs from 26 foreign countries at reduced prices faces a formidable hurdle in the Senate. Even with House approval of the drug reimportation measure, high-profile Senators of both political persuasions worry the safety risks surrounding reimported medications may be too great to ignore.

Proponents of the House bill admit the future of their legislation is uncertain. However, they say the July 243-186 vote to approve the measure–opposed by the White House, Republican leaders, the Food and Drug Administration, and the pharmaceutical industry–was evidence of growing grassroots demand for less-expensive prescription drugs.

“I don’t know if we are going to win this fight,” said Rep. Dan Burton (R-Indiana), a conservative who joined some of the House’s most liberal Democrats in supporting the bill. But “we sent a very strong message” to the pharmaceutical industry, said Burton, who believes firms will have no choice but to reevaluate the prices they charge U.S. consumers.

The House bill, introduced by Rep. Gil Gutknecht (R-Minnesota) and cosponsored by Jo Ann Emerson (R-Missouri) and Rahm Emanuel (D-Illinois), requires the Department of Health and Human Services (HHS) to establish a system to allow the reimport of FDA-approved drugs from FDA-approved facilities in Canada, the European Union, and seven other nations. The measure also would require that reimported medicine be shipped in special packaging designed to discourage tampering and counterfeiting.

The Gutknecht measure goes well beyond reimportation language present in the Senate and House Medicare reform measures, currently being reconciled in a conference committee. Both chambers’ Medicare bills would allow reimportation only from Canada, and both would require HHS to certify the reimported drugs as safe.

No Guarantee of Safety

Twice before, Congress has passed legislation addressing drug reimportation. Both measures required HHS certification of a drug’s safety before reimportation would be permitted. Neither Donna Shalala, who served as HHS secretary during the Clinton administration, nor Tommy Thompson, the current secretary, has certified as safe any reimported drugs.

Fifty-three Senators, including Edward Kennedy (D-Massachusetts) and Orrin Hatch (R-Utah), have signed a letter opposing efforts to make it easier to reimport drugs into the U.S. from foreign countries. “We do not believe it would be prudent to remove these vital safeguards,” the Senators write, “especially when Congress is enacting a Medicare measure that includes improved access to more affordable generic drugs.”

The Pharmaceutical Research and Manufacturers of America, which represents the nation’s name-brand drug industry, said it was encouraged by the senators’ opposition to legislation they said would jeopardize the safety of the country’s medicine supply and import foreign governments’ price controls.

James Glassman, resident fellow at the American Enterprise Institute, raises a different concern. “It is not too dramatic to say that, if it becomes law, this bill will make Americans sicker and shorten their lives. The reason is simple. The bill would introduce Canadian price controls to the United States. The results are eminently predictable. If U.S. drug companies are forced to sell at prices that prevail in Canada and Europe, they will sharply curtail, or in many cases abandon, the development of new pharmaceuticals.”

The Bush administration called the bill “dangerous legislation.” Food and Drug Administration Commissioner Mark McClellan warned the measure “creates a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to public health and pose a threat to the security of our nation’s drug supply.”

Supporters of the Gutknecht bill vowed to reject any Medicare reform bill that does not include what they call a “market access provision” to allow U.S. residents to purchase prescription drugs from other nations.

Pipeline to Consumers

Were the Gutknecht bill to become law, U.S. pharmacies would likely reimport prescription drugs. Todd Andrews, chief spokesperson for the pharmacy chain CVS, said “if a program were put into place that gave us the opportunity to purchase high-quality medications at substantial savings for ourselves and our customers, then we would certainly take advantage of that program … whether it’s overseas or domestic.”

Joe Smith, president of the National Community Pharmacists Association, which represents about 25,000 independent pharmacies, said the group would consider the practice. “In the worst-case scenario, I think, yes, we would go overseas to get drugs for our stores. And we would probably do it as a buying group or through our wholesalers … rather than me trying to deal with the differences of currencies and importation laws and duties.”

But not all pharmacies would accept reimportation. Craig Fuller, CEO of the National Association of Chain Drug Stores, told the Washington Post, “U.S. wholesalers that purchase medications from pharmaceutical companies and sell them to retail pharmacies may not import prescription drugs from other nations, because the wholesaler obviously wants to have assurance that the products that they are selling to the retailers are safe.”

Fuller added, “Until you can be assured that the medications you are importing in fact meet the high standards that we have today, people are going to be reluctant to do that. At this point, it would be too hypothetical to speculate how retailers might go about doing that.”

“The best solution,” writes Glassman, “is for all nations to do what the U.S. does: Establish a relatively free market in drugs. If that happened, drug companies would be able to afford to invest even more than the $30 billion a year they currently put into research and development. The world would have more new medicines, and people would be healthier and live longer.”

Conrad F. Meier is managing editor of Health Care News. His email address is [email protected].

For more information …

James Glassman’s essay, “Importing Socialism,” is available online at http://techcentralstation.com.