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Dec. 28, 2005
Copyright © Las Vegas Review-Journal


BUYING FROM CANADA: Opinion: Drug law a no-go

FDA rules within legislation sink program, attorney general says

By SEAN WHALEY
REVIEW-JOURNAL CAPITAL BUREAU


CARSON CITY -- A legal opinion issued by the attorney general's office Tuesday said legislation allowing Nevada residents to buy less expensive prescription drugs from Canada via the Internet is unworkable.

The opinion brings to a halt the move to provide access to government-subsidized drugs from Canadian pharmacies.

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The opinion was sought by the state Board of Pharmacy before it started the program, which was backed by some members of the 2005 Legislature in one of the hardest-fought issues of the session.

The opinion said the measure creating the program, Senate Bill 5, states the drugs that can be bought are those that have been approved by the U.S. Food and Drug Administration.

Approval means those drugs "for which application has been properly made and which have successfully passed the FDA review process and have been awarded approval by the FDA," the 19-page opinion from Attorney General George Chanos said. "Unfortunately, few if any prescription drugs imported from Canada, would meet the standards for importation established by the Nevada Legislature in the legislation.

"In essence, the quality standard adopted by the Nevada Legislature is, as a practical matter, unworkable," the opinion said.

The FDA standard cannot be met, Chanos said, because the Canadian drugs do not meet all of the FDA requirements, including in their packaging.

The Legislature will have to revisit the issue in 2007 if lawmakers want the program put into place, the opinion concluded.

Sen. Joe Heck, R-Henderson, a physician and supporter of the legislation, criticized the opinion for relying on a technicality to stop the program.

Heck argued that FDA approval should be defined to mean a drug compound approved by the agency even if it comes from another country with some minor packaging differences, such as a different kind of label.

But the attorney general's opinion took a more restrictive interpretation and said that FDA approval means compliance in all respects, including "container closure system and appearance." Each drug must meet U.S. labeling requirements.

"This does a great disservice to people on fixed incomes and low to moderate incomes to get the drugs they need for basic survival," Heck said. "It truly takes the drugs out of the people's possession out of a technicality and not because it is in the best interests of public health."

Assembly Majority Leader Barbara Buckley, D-Las Vegas, who sponsored the bill, said the opinion comes from pressure by a pharmaceutical industry worried about profits.

"My opinion is that ultimately common sense is going to prevail over special interests," she said. "There is no reason why this program should not go forward."

Buckley said the language in the legislation is clear and is backed by staff legal opinion: FDA approval means approval of the compound, not how the product is labeled or packaged.

"If Lipitor is approved by the FDA, then it can be imported from Canada," she said.

The opinion from Chanos is the result of a "tortured" legal opinion sought by the pharmaceutical industry through the FDA, which forwarded its legal interpretation to Chanos, Buckley said.

The opinion issued by Chanos has no force, and Buckley said she will ask the Pharmacy Board at its next meeting to side with the Nevada Legislature and not the legal opinion pushed by special interests.

Chanos defended the opinion and said the interpretation sought by Buckley and Heck over the term "FDA approved" is different from what was presented in the Legislature.

"I am absolutely convinced there is no question that we have arrived at the correct conclusion," Chanos said. "I am fully comfortable with our legal analysis."

Two problems existed with the legislation, Chanos said.

The FDA-approved definition is one problem, and that definition goes so far as to say that a drug label can be in English only. But drugs sold in Canada also have labels written in French, he said.

The other issue is that the FDA requires that drugs be manufactured in an approved facility, information that the Pharmacy Board discovered was unattainable because of limitations in the U.S. Freedom of Information Act, Chanos said.

"The definition of FDA approval currently being advanced by Sen. Heck and Assemblywoman Buckley bears no resemblance to the definition they offered during the legislative session," he said. "My interpretation, I am completely confident, is accurate."

Gov. Kenny Guinn expressed doubts about the legality of the plan but signed the measure into law in June.

The Pharmacy Board then went through a licensing process, including trips to Canada to inspect the pharmacies that wanted to participate in the program. But the opinion, which took longer than expected to produce, has ended the program before it began.

Guinn spokesman Steve George said the governor's concerns were that he wanted the program to be safe and in compliance with federal law.

The Legislature made every effort in that regard, but the attorney general has raised the concern that Canadian drugs do not meet FDA requirements, he said. "If something can be done in the future to make it work for Nevada, the governor will be happy to support that."

Brand-name drugs are 30 percent to 50 percent cheaper in Canada because they are sold under government price controls.

Several states have started Canadian drug programs, including Vermont, Minnesota, New Hampshire and North Dakota. But the Texas attorney general ruled last week against that state's Canadian pharmacy law, which was modeled after the program in Minnesota.

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