Healthy Skepticism Library item: 1473

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Rowland C.
FDA mulls drug-import action: Agency says it may charge states, cities
The Boston Globe 2003 Nov 7

Full text:

Seeking to clarify and strengthen its stance on Canadian prescription drugs, the Food and Drug Administration said yesterday that it would consider prosecuting state and local governments that establish importation programs for their workers.

The statement — coming on a day when the agency won a key court battle in Oklahoma against a private US business involved in the Canadian drug trade — appeared to contradict a stance articulated last month by an FDA official.

“We are . . . committed to enforcing the law against those, whether governmental or private, who endanger Americans by profiting from `buyer beware’ schemes to import illegal, unapproved and potentially risky medicines,” FDA Commissioner Mark McClellan said in a press release.

Last month in Boston, William Hubbard, the agency’s associate commissioner for policy and planning, said the FDA did not plan to take action against the City of Springfield or other public entities following Springfield’s lead. Springfield so far has the only importation program in the country. “We’re not considering legal action against cities or states,” Hubbard said at a press briefing following an Oct. 23 State House hearing.

Hubbard said yesterday that a Globe article the next day about his statement misconstrued his comment. While the article said the FDA had adopted a hands-off policy to government entities engaging in the practice, that was not what he meant, Hubbard said.

“What I was trying to say was we have not specifically considered any action against any other government, because it’s hypothetical, because it’s a moot point,” Hubbard said yesterday. “The only government that’s doing anything is Springfield.”

Mayor Michael Albano of Springfield said the FDA was guilty of a “flip-flop.”

“It doesn’t surprise me given the inconsistency on this position all along,” he said.

The FDA is attempting to strike a difficult balance on the question of prescription drugs from Canada, which are 20 to 80 percent cheaper because of Canadian government price controls. Importation is illegal, but the agency has a policy of looking the other way while an estimated 1 million to 2 million Americans order their drugs from across the border. It has strongly warned against group purchasing by cities, states, and private health plans.

It also has targeted US businesses that earn a commission by drumming up sales for the Canadian pharmacies. The FDA scored a victory yesterday against one such US “storefront” company offering access to Canadian drugs. A judge in Tulsa granted the government’s request to shut down RxDepot Inc. and Rx of Canada LLC, businesses operated by New England Revolution soccer player Joe-Max Moore and his father, Carl Moore.

“This court is not unsympathetic to the predicament faced by individuals who cannot afford their prescription drugs at US prices,” wrote US District Judge Claire Eagan. “However, the defendants are able to offer lower prices only because they facilitate illegal activity determined by Congress to harm the public interest.”

The FDA also issued a letter yesterday reiterating its position that CanaRx Services Inc., Springfield’s supplier of Canadian drugs, is operating outside of the law. Hubbard said that CanaRx operates in Ontario, but that it could be subject to US civil proceedings “in absentia.”