May 8, 2007
Senate Vote Upholds Drug Import Limits
By ROBERT PEAR
WASHINGTON, May 7 — The Senate voted on Monday to preserve current restrictions
on the importing of lower-cost prescription drugs from Canada and other
countries, fearing that such imports could pose risks to consumers, even with
new safeguards.

By a vote of 49 to 40, the Senate approved a measure saying that imports will
not be allowed unless the secretary of health and human services first certifies
that they “pose no additional risk to the public’s health and safety,” and that
they will significantly reduce costs to consumers.

Consumer advocates have long favored such imports as a way to make medicines
more affordable. But health officials in the Clinton and Bush administrations
have blocked such efforts, saying they cannot guarantee the safety of imported
medicines.

Senators Byron L. Dorgan, Democrat of North Dakota, and Olympia J. Snowe,
Republican of Maine, were the chief sponsors of the original proposal, which
would allow imports.

“American consumers are paying the highest prices in the world for brand-name
prescription drugs,” Mr. Dorgan said. “We are trying to change that.”

Mr. Dorgan’s proposal would have allowed consumers, pharmacists, drug
wholesalers and distributors to import prescription drugs from Canada, Japan,
Australia and European countries found to have regulatory requirements
comparable to those in the United States.

Arguing against the proposal, Senator Thad Cochran, Republican of Mississippi,
cited an article in The New York Times on Sunday that described how people had
died after taking medicines contaminated with a toxic, sweet-tasting syrup
imported from China.

“Counterfeit drugs contaminated with an industrial solvent have poisoned
hundreds, if not thousands, of people around the world,” Mr. Cochran said. “The
toxic syrup has been involved in at least eight mass poisonings around the world
in the past two decades.”

By voice vote, the Senate approved the Dorgan proposal, but only after amending
it to require the certifications of safety and savings.

In an interview, Mr. Dorgan said that amendment “was designed to kill
importation” and would have that effect.

The issue came up in debate on a bill that gives the Food and Drug
Administration more power and money to ensure that drugs are as safe as
advertised. The bill would increase the fees paid by regulated drug companies to
help finance the agency’s operations.

Senator Michael B. Enzi, Republican of Wyoming, said it was paradoxical that “in
the midst of our work on the biggest drug safety reform in a decade, we are
considering the issue of drug importation,” which he said would increase risks
to consumers.

Both parties split over Mr. Cochran’s amendment to require a safety
certification before allowing large-scale drug imports. Fifteen Democrats voted
for it, and 28 opposed it. Thirty-three Republicans supported it, while 11 voted
nay. The two independent senators also split.

Senator Edward M. Kennedy, Democrat of Massachusetts, was a pivotal figure. He
is the chief author of the bill overhauling the F.D.A. In the past, Mr. Kennedy
has voted to allow drug imports, and he is a co-sponsor of a bill to do just
that.

But on Monday, Mr. Kennedy voted against Mr. Dorgan’s proposal, and encouraged
others to do so, because he feared that it would sink the overall bill granting
new powers to the food and drug agency.

President Bush had threatened to veto legislation that allowed drug imports
outside the existing system. The White House said such legislation would “result
in unsafe, unapproved and counterfeit drugs being imported into the United
States.”

Mr. Kennedy cited the veto threat in explaining why he voted for Mr. Cochran’s
amendment.

Mr. Dorgan said the vote showed “the clout that the drug industry has here in
Congress.”

Congress has repeatedly tried to allow drug imports. This year, Mr. Dorgan added
several safeguards intended to reduce the risks of imports.

For example, under his proposal, the drug agency could inspect warehouses and
other property of foreign exporters and domestic importers. Moreover, federal
officials would have to verify the “chain of custody” of imported drugs.