[Ip-health] USA Today FDA on Canada drugs: No way

[Kate Krauss]

Posted 12/23/2003 9:16 AM


FDA on Canada drugs: 'No way'
By William M. Welch, USA TODAY

WASHINGTON =8B The Bush administration warned Monday that states and cities
seeking to import lower-cost drugs from Canada face legal action and
financial liability.

Citing safety concerns, officials at the Food and Drug Administration and
Health and Human Services Department used their strongest language yet in
response to appeals by governors and mayors who hope to save money for
governments and consumers.

"It's very clear it's absolutely illegal," said Peter Pitts, an FDA
associate commissioner. "There's no way importing drugs not FDA-approved ca=
n
be legal in any way or form."

At least 10 states have expressed interest in buying less-expensive Canadia=
n
drugs for state workers, retirees, prison inmates or citizens, or in helpin=
g
direct consumers toward legitimate Canadian retailers. None has done so yet=
,
but two cities =8B Springfield, Mass., and Montgomery, Ala. =8B are running
programs. (Related item: Montogmery quietly saving about $500,000)

The Bush administration says imported drugs could be tainted, old or fake.
Drug companies that charge higher prices in the USA fear imports could lead
to price controls in this country.

The administration's warning followed a move to force Bush's hand on the
politically volatile issue by Illinois Gov. Rod Blagojevich, a Democrat. He
requested a waiver to let the state buy drugs from Canada for state workers
and retirees. He estimates it would save the state $91 million a year. The
administration's response was an effort to keep the focus on safety, rather
than let Democrats frame it as a consumer issue.

Administration officials said the request was sure to be rejected. Bill
Pierce, spokesman for Health and Human Services Secretary Tommy Thompson,
said Thompson cannot certify the safety of imported drugs because they pass
outside the FDA's scrutiny during manufacture or shipment. "They're going t=
o
have to break the law to do it," he said.

An overwhelming 71% of Americans in a recent USA TODAY/CNN/Gallup Poll
supported legalizing prescription drug sales from Canada, where the
government negotiates prices with manufacturers.

The FDA contends it is illegal for U.S. citizens to purchase drugs from
foreign sources. But they have told Customs officials to permit individuals
to re-enter the country with up to 90-day supplies of drugs for personal
use. A new Medicare law signed by President Bush this month maintains the
prohibition on imports but authorizes the HHS secretary to conduct a study
on the safety of Canadian imports.

Federal officials said any mayor or governor moving ahead with an
importation program risks potential enforcement efforts. Tom McGinnis, FDA
director of pharmacy affairs, said state and local officials could be
regarded as "aiding and abetting" law violations. He said the FDA, acting
through the Justice Department, could file civil lawsuits to halt drug
imports.

McGinnis said states and cities could face criminal action and financial
liability if anyone is harmed by imported drugs. He said FDA lawyers are
telling states and cities, "If you do it, you're going to be at risk."

The FDA's threats previously prompted Springfield's supplier to close its
U.S. offices. McGinnis said the agency hopes to persuade the incoming mayor=
,
who takes office in January, to shut down the program.