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.