Dorgan bill defeated, but drug importation is not dead, says White House

Proposals to allow pharmacies and wholesalers to cut costs by importing cheaper prescription drugs from selected overseas markets have been blocked in the US Senate.

The Pharmaceutical Market Access and Drug Safety Act proposed by Senators Byron Dorgan (Democrat - North Dakota) was designed to cut the drug's bill in the USA and encourage price competition in the domestic market.

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

Dorgan and the 11 co-sponsors of the bill had said they believed the measure would cut drug spending by up to $100bn over the next 10 years, although a Congressional Budget Office puts the direct savings at $19.4bn.

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

The Dorgan bill received 51 votes in favour and 48 against but needed to clear a 60-vote threshold to pass.

Dorgan said in a statement after the defeat that he believed Senators had been swayed by an offer from the Pharmaceutical Research and Manufacturers of America (PhRMA) to increase the value of an $80bn deal, agreed with the White House, to support the broader package of healthcare reform legislation (HR 3590). The Dorgan proposal was an amendment to that legislation.

The PhRMA denies any such offer has taken place. The industry body's senior vice president Ken Johnson, said: "we believe that if health reform is done in a smart way, prescription drug importation is not necessary because most Americans will finally have health insurance and access to safe and secure prescription medicines."

Obama still behind importation?

Meanwhile, the Barack Obama administration has said it will press ahead with plans to allow imports from Australia, Canada, the European Union, Japan and New Zealand, but separate the issue from the current healthcare reform effort, according to a Reuters report which cited a CNN interview with White House adviser David Axelrod.

Axelrod said Obama favours "safe re-importation" of medicines from well-regulated markets, but recognises FDA concerns that it dies not currently have the resources to handle the increased workload and that it does not have clear authority over foreign supply chains.

A letter to Senators from FDA Commissioner Margaret Hamburg sent ahead of the vote identified four key areas of concern for the agency, namely that imported drugs:

• may not have been subject to rigorous regulatory review before approval;
• might not be good quality and made in a facility that adheres to Good Manufacturing Practices;
• might have differences in manufacturing processes and composition compared to product approved for sale in the USA; and
• could be contaminated or counterfeit “due to inadequate safeguards in the supply chain."

Supporters of the amendment have accused the FDA of colluding with the White House, making the safety of imports a 'stalking horse' issue in order to help ease the reform package through the Senate.

Dorgan had argued his legislation contained safeguards to prohibit counterfeit drugs from entering the system or other practices that would put the consumer at risk, and applied only to FDA-approved prescription drugs produced in FDA-approved plants from countries with comparable safety standards.

Meanwhile, a watered down amendment introduced at the eleventh hour by Senator Frank Lautenberg (Democrat - New Jersey)   which would have allowed importation only when products were certified by the Health and Human Services Secretary as being safe and cost-effective was also voted down by 56 votes to 43.


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