The US Senate voted 49-40 on May 7 in favour of a provision which

would require the Department of Health and Social Services (DHHS) to

certify the safety and lower prices of prescription drugs imported

into the USA from abroad.

Federal health officials have, in the past, stressed that they would

not be able to provide such assurances and the proposal, which was

put forward by Republican Senator Thad Cochran, is widely seen as

unworkable. It also throws out an amendment, proposed by Democrat

Byron Dorgan, to allow pharmacies and drug wholesalers to import Food

and Drug Administration-approved medicines from Australia, Canada,

Europe, Japan and New Zealand. The Dorgan Foreign Drug Act amendment,

which is backed by seniors and consumer advocacy groups, was later

approved by the Senate on a voice vote, but was neutralised by the

addition of the Cochran proviso.

Opening the door to counterfeits?

The Senate vote attaches the Cochran amendment to the Food and Drug

Administration Revitalization Act (S 1082), which will re-authorise

the Prescription Drug User Fee Act, rather than the Dorgan

measure, which has been fiercely opposed by the Administration. The

White House had stated flatly that President George W Bush would veto

any legislation which included such an amendment. And,

ahead of the Senate vote, HHS Secretary Mike Leavitt warned that the

Dorgan provision “would open the door for counterfeit drugs to enter

our domestic pharmaceutical supply.”

“Allowing the importation of drugs outside the current safety system

would pose an immediate and significant risk to the public health in

the United States,” added Sec Leavitt. Moreover, he said, attaching

the amendment to S 1082 would threaten the timely reauthorization of

PDUFA and its companion bill covering medical devices, cost the FDA

revenue fees equal to around a quarter of its annual operating budget

and require the agency to shed over 2,000 jobs.

In contrast, the White House has said that approval of the Cochran

amendment would ease its concerns about the safety of imported drugs

and probably avoid any need for a veto.