roposals to allow US pharmacies and wholesalers to import prescription drugs from Australia, Canada, the European Union, Japan and New Zealand have been defeated in the Senate.
The measure, proposed by Democrat Byron Dorgan and Republican Olympia Snowe, received 51 votes in favour and 48 against but needed 60 votes to pass. Senator Dorgan claimed that US consumers are paying up to 55% more for their prescription drugs than those in Europe and Canada, and that his amendment - which was co-sponsored by 11 Democrats and four Republicans - would produce savings of $100 billion over 10 years. However, the Congressional Budget Office (CBO) has put the figure at just $19.4 billion in the period.
The vote was welcomed by Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president Ken Johnson, who 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.”
However, the seniors group AARP, which supported the measure, said it was disappointed by the vote. Senators “had a choice between meaningful savings for their constituents and higher profits for the drug industry,” said the group, which added that it would continue working with legislators to get the proposal implemented.
Another proposed amendment, to allow drug imports only if they had their safety and economic benefits certified by the Health and Human Service (HSS) Secretary, also failed to achieve the required 60 votes in the Senate, garnering 56 in favour and 43 against.
President Barack Obama had publicly supported importation during his presidential campaign last year, but ahead of the vote, FDA Margaret Hamburg warned in a letter to the Senate that there were “significant safety concerns” with Sen Dorgan’s proposal.
She warned of “four potential risks” that an imported drug might not be safe, because: - it might not have been subject to a rigorous regulatory review prior to approval; - it might not be a consistently-made, high-quality product because it was not manufactured in a facility that complies with appropriate good manufacturing practices; - it could have differences in composition and manufacturing; and - it could be contaminated or counterfeit “due to inadequate safeguards in the supply chain."
However, critics claim that moves by the Administration to protect the $80 billion deal agreed in June between PhRMA and Senate Finance Committee chairman Max Baucus, and sanctioned by the White House, are behind the Commissioner’s letter.