Drug importation threatens to derail US health reform

A bipartisan amendment aimed at carving $19.4bn off federal healthcare spending over the next 10 years by allowing US citizens to import medicines from overseas is holding up voting on a healthcare reform bill.

The Pharmaceutical Market Access and Drug Safety Act, proposed by Senator Byron Dorgan (Democrat, North Dakota) on December 8, is designed to force drugmakers to lower prices in the USA, which tend to be higher than most other countries around the world.

Critics of the legislation - including pharmaceutical industry groups - claim the move could expose the pharmaceutical supply chain to counterfeit and adulterated medicines.

The proposal would allow licensed pharmacies and drug wholesalers to import medications approved by the US Food and Drug Administration (FDA) from certain markets, including Canada and Europe. Individual consumers would also be able to purchase prescription drugs for personal use from FDA-inspected pharmacies in Canada.

It would also overturn an informal agreement between the Barack Obama administration, Senate Finance Committee Chairman Max Baucus and the main US pharma group - the Pharmaceutical Research and Manufacturers of America - which limited cuts in drug spending in return for PhRMA support of its healthcare reform package. The Dorgan proposal is an amendment to that legislation.

Dorgan and co-sponsors such as John McCain (Republican, Arizona) maintain that other elements in the bill, which includes tighter registration requirements and a hike in the number of overseas facility inspections by the US Food and Drug Administration, will avoid an increase in counterfeiting and improve overall drug safety.

FDA Commissioner Margaret Hamburg has also expressed reservations about the ability of its inspectors to implement the demands of the proposal in a letter to senators, as well as the potential increase in risk, saying that the FDA does not have clear authority over foreign supply chains.

In response, Dorgan and his co-sponsors stress the amendment applies only to FDA-approved drugs produced in FDA-inspected plants from countries with comparable safety standards.

A vote on it was delayed yesterday in the Senate, amid concerns that if it passes it could derail the entire healthcare reform agenda. And to add to the complexity, another 100-page amendment was tabled late in the day by Senator Frank Lautenberg (Democrat, New Jersey), which also contains drug importation elements.

Few details of the Lautenberg amendment were available as this article went to press.

Meanwhile, two groups lobbying to block the amendment because of safety and counterfeit issues include the Healthcare Distribution Management Association (HDMA) and senior advocacy group RetireSafe.

"Efforts to sell counterfeit or adulterated medications produced overseas have become far more sophisticated in just the past few years, said HDMA chief executive John Gray.

"Rather than exposing US patients to such risks, Congress should enhance the safety and security of the domestic supply chain through enactment of a uniform federal pedigree standard," he said.

Meanwhile, RetireSafe president Thair Phillips said: "Senator Dorgan's importation amendment is poised to open our borders, allowing our safe, closed drug system to be breached, and our health to be endangered."

Pedigree revisited

Meanwhile, the HDMA has also expressed concern about provisions in the legislation which call for implementation of a track-and-trace system by 2012.

"While this effort to address patient safety is well-intentioned, it is not aligned with industry capabilities, technological developments, or federal guidance on product serialisation," said Gray.


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