Nevada drug importation program gets go-ahead

Nevada physicians and lobbyists swayed the Nevada State Board of Pharmacy on Jan. 12 to approve a state importation program that allows residents to buy prescription drugs from Canada through a state-sponsored Web site, as long as the medications are approved by the Food and Drug Administration.

The groups overcame an opinion by state Attorney General George Chanos that would have gutted the program.

At the meeting, the Nevada State Medical Assn. reinforced its support of the law's provision for FDA approval, written by Sen. Joe Heck, DO, to ensure the safety and composition of Canadian drugs.

Physicians say the Nevada law has adequate safeguards. "Doctors want to see [the program] tried," said Larry Matheis, NSMA executive director. Other protections require the board to inspect the Canadian pharmacies, he added.

The program was created by a state law enacted last June. Confusion over the intent of the law's language requiring FDA approval of imported drugs loomed over the pharmacy board, which is responsible for licensing pharmacies. The panel sought clarification from Chanos.

He strictly interpreted the provision to mean that the FDA would have to approve the safety of imported medications, rather than simply requiring that drugs had gone through the agency's regular approval process.

At the Jan. 12 meeting, the board decided to proceed in spite of Chanos' nonbinding opinion.

Dr. Heck, an emergency physician at University Medical Center in Las Vegas, explained that his intent was that FDA-approved means that "the pill in the bottle is approved by the FDA for use in the U.S." He added that agency approval did not imply receiving the FDA's blessing for importation, knowing that would have doomed the program.

As long as the Canadian drug is the same formulation approved by the FDA's rigorous process, it can be licensed, despite where it is manufactured, Dr. Heck said.

An earlier draft of the bill would have allowed imported drugs approved by the Canadian government. But Dr. Heck said he wanted to make sure patients get exactly the same drugs as those available in the United States. So he revised the bill to include only FDA-approved drugs.

Convinced of this intent, Larry Pinson, executive secretary for the Nevada Board of Pharmacy, said everyone reached a "good compromise" that allows the board to write the regulations for drug safety. The board aims to complete them for an April 20 meeting for public comment. Pinson anticipates that the program will be up and running in May.

"[Pharmacies] are shipping here whether we are licensing them or not," he said. "If we can at least identify some through our inspection processes to be safe and reputable, then we can have some control."

Advocating for patients

Doctors say the same medications they have prescribed over the last 20 years have doubled or tripled in price, and their concern was getting access for their patients. For Nevada, one option was Canada.

"If that's what helps make medications affordable, then our responsibility as advocates is to help set up that program and make sure it's a good one," said John A. Ellerton, MD, a Canadian oncologist who practices in Las Vegas. Dr. Ellerton participated in drafting the bill and attended the Board of Pharmacy meeting to support the program as NSMA co-chair of governmental affairs.

When Chanos released his opinion, doctors were not pleased. "I had to call my mom in Canada and tell her that the attorney general says her drugs aren't safe," Dr. Ellerton said.

Chanos said he is not against Canadian drug importation and would like to help Nevadans get affordable prescription drugs. "But my job is to interpret the law," he said.

Like many other states, Nevada is fighting the challenge of high-cost drugs and acknowledges that importation violates federal law. In 2005, 50 bills were introduced in 21 states addressing the issue, according to a report from the National Conference of State Legislatures.

American Medical Association policy supports drug importation only if the medications are FDA-approved and can be traced, and if Congress gives the agency the green light to ensure imported drugs' safety.