US Senate debating Dorgan's importation of prescription drugs bill; strong opposition from several quarters

Under bipartisan legislation that US Senator Byron Dorgan (Democrat, North Dakota) is pushing to include in the health reform bill, it is estimated that the federal government could save $19.4 billion over the next ten years. The Senate is expected to vote this week on Dorgan's amendment.

Sen Dorgan's legislation, called the Pharmaceutical Market Access and Drug Safety Act, would allow American consumers to safely import lower-priced, Food and Drug Administration-approved drugs from other countries, including Canada. The Senator said the legislation will ultimately force the pharmaceutical industry to lower drug prices in the USA.

'As we confront the ever-increasing cost of health care ' which is projected to exceed $33 trillion in the coming decade ' the imperative is clear that we must address rising costs, or affordable access to coverage simply cannot be achieved and sustained,' said Senator Olympia Snowe (Republican, Maine), a co-sponsor of Dorgan's amendment. 'By implementing a safe prescription drug importation program, this amendment will increase competition within the domestic prescription drug market which, in turn, will ensure more Americans have access to affordable medications. This is a common sense approach that will guarantee Americans can safely secure the medications they rely on to improve their overall health and well-being,' she said.

However, it faces significant opposition, not least from the Obama Administration, which yesterday raised safety concerns about Dorgan's amendment. Sen Dorgan is surprised and criticized the FDA for trying to derail his proposal, which could blow apart an agreement between the White House, Senate Finance Committee Chairman Max Baucus and the Pharmaceutical Research and Manufacturers of America (PhRMA) on health care reform.

Capitol Hill observers say that Sen Dorgan "could assemble a bipartisan coalition of more than 60 votes to disregard the agreement to limit PhRMA's financial exposure in exchange for its support of reform, which would risk a battle with a powerful industry that has fought health care reform in the past."

Meanwhile, according to CNN, Senator Bill Nelson (Democrat, Florida) is insisting the Senate consider yet another amendment that could break up the industry agreement. He wants drugmakers to give the government rebates on drugs sold to Medicare and Medicaid patients, thereby closing the 'doughnut hole' - a gap in Medicare Part D coverage. The plan could cost the industry $106 billion over 10 years.

HDMA and RetireSafe raise safety and counterfeit issues

Responding to the proposed legislation John Gray, chief executive of the Healthcare Distribution Management Association (HDMA, said: "Importation of prescription drugs from foreign countries, as Senator Dorgan and others propose to allow, would compromise the secure US distribution system by increasing the likelihood of entry for counterfeit or adulterated medicines. Efforts to sell counterfeit or adulterated medications produced overseas have become far more sophisticated in just the past few years. 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 added: "We are very concerned 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 serialization. States that have looked at track-and-trace issues in depth understand the complexity of such an undertaking. That is why the most aggressive time horizons established by states for track-and-trace implementation begin in 2015...Before opening our borders, a realistic, comprehensive approach is needed to counter these threats, facilitate interstate commerce and reconcile inconsistencies among the patchwork of state requirements currently in place. Importation is and will be an unsound policy until these issues are addressed."

Adding its voice to the safety debate, the senior advocacy group RetireSafe urged the Senate to defeat the Dorgan Importation plan encompassed in SA 2793. 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. We could soon be getting drugs that were stored in tin containers and car trunks. This could literally be a 'killer' amendment, it puts all Americans and especially seniors at risk, and it should be soundly defeated."