Last October, Illinois and Wisconsin launched the I-SaveRx prescription drug program, becoming the first states to allow their residents to purchase lower-priced prescription drugs from Europe and Canada. Nevada figured to join their ranks earlier this year—What? Progressiveness in state social services?—when lawmakers passed legislation allowing Canadian prescription drugs into the market.
This being Nevada—world heavyweight champion of poor quality-of-life stats—something was bound to happen on the way to cheaper drugs for the masses.
Since September, the state's program has been in legal limbo—awaiting a ruling from the state Attorney General's office over the meaning of "FDA approved" (Food and Drug Administration).
"We asked for the Attorney General's opinion in the third week of September," says Louis Ling, attorney for the Nevada State Pharmacy Board, regulator of state pharmacies. "Nothing is going anywhere on the program until we get that opinion."
Ling says the legislation, as written, allows for evolving definitions of "FDA approved."
"There have been at least three different opinions on what it means," he says. "A representative from a pharmaceutical manufacturer told us it means that (Canadian) drugs meet the same standards as drugs for sale in a U.S. pharmacy—it has to have a bar code and national drug code number. There are people who advocate on behalf of the program that say FDA approved means that the (main) molecule in the drug has been approved for use in the human body by the FDA. Another opinion is that the drug has to be approved for use in the U.S. and has to have come from a plant approved by the FDA—this means that the stuff rolling out of the plant is FDA approvable even if it doesn't have a bar code and an NDC number."
So what does the FDA say?
According to its website: "If a product has FDA approval (or in some cases FDA clearance), it has met FDA's rigorous standards and may be sold legally in the United States."
Since that's not much help, here's a quick course on FDA approval: Drugs must have a new drug-approval application, which includes research results and enough information to decide if "the drug is safe and effective in its proposed use or uses, the benefits of the drug outweigh the risks, the drug's proposed labeling (package insert) is appropriate and the methods used to manufacture the drug are adequate to preserve its identity, strength, quality, and purity."
Also required: Animal studies, "to see if a new drug will be effective and adequately safe for human studies; Phase I clinical trials, usually involving 20 to 80 subjects, "to determine drug safety"; Phase II clinical trials, which feature a larger group of subjects, "to further explore safety and to determine effective dosage for a specific indication"; Finally, phase III clinical trials involving thousands of subjects "to determine the overall benefit-risk relationship of the drug and to characterize the drug for its intended use."
Confused yet?
Thus the request for the AG's opinion.
In response to federal concerns about the safety of imported prescription drugs, many states have set up safeguards. (Though the federal Food, Drug and Cosmetic Act bans the re-importation of most prescription drugs, the feds haven't cracked down on states pursuing this; some 28 bills were considered in states last year.) If state legislation goes into effect, Ling says the pharmaceutical companies will have restrictions on what drugs they can sell. "For example, they can't sell drugs that are generic in Canada but haven't been ruled generic in the U.S., and they can't sell controlled substances," he says. "They (pharmaceutical companies) are doing formularies for municipalities, counties and states elsewhere and would do them here as well."
"These would become Nevada-licensed mail-order pharmacies," Ling adds, noting that there wouldn't be any customer eligibility requirements. "They could be used by cash-paying customers or customers could ask their insurance companies to cover the drugs. Generally, in the average pharmacy, 85 to 90 percent of prescriptions are paid by someone else—insurance, Medicare."
Two of the 10 Canadian pharmacies endorsed by the pharmacy board withdrew before being inspected. Of the five inspected, Ling says, four could potentially be approved. He says the delayed ruling is probably due to new Nevada Attorney General George Chanos getting his bearings. Chanos replaced Brian Sandoval, who was confirmed to a federal judgeship in October.
"AG's don't often change mid-stream," he says. "Mr. Chanos came into the office with a whole lot of issues, this being one of them."
Barry Gold, associate state director for advocacy for the Nevada office of the American Association of Retired People, sees the Canadian prescription drug program as another option for seniors to get affordable medicines. It could certainly be a boon for some of the AARP's 116,000 Las Vegas members.
"Some people will take advantage, some will be leery," Gold says. "The mail-order option is already popular among seniors, particularly homebound seniors. This could be, too."