I am so glad the Bush Administration's FDA is watching out for us poor unsuspecting consumers....

FDA on Canada drugs: 'No way'

By William M. Welch, USA TODAY
WASHINGTON — 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 can be legal in any way or form."

At least 10 states have expressed interest in buying less-expensive Canadian drugs for state workers, retirees, prison inmates or citizens, or in helping direct consumers toward legitimate Canadian retailers. None has done so yet, but two cities — Springfield, Mass., and Montgomery, Ala. — 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 to 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.

USA Today FDA on Canada Drugs No Way