Per Ed Silverman over at Pharmalot:
Seeking a way to alleviate high drug prices, a Utah lawmaker hopes to introduce a bill that would allow the state to import prescription medicines from Canada, a move that is likely to accelerate a fierce debate over drug costs and patient safety.
Over the next several weeks, Rep. Norman Thurston, a Republican, plans to submit legislation to authorize state officials to designate an existing pharmaceutical wholesaler to purchase prescription drugs from a wholesaler in Canada. His hope is that retail pharmacies based in Utah would then be able to buy and sell medicines at lower prices.
“We’re still trying to work out some of the details, but we envision a safe supply chain that would result in significant cost savings for the citizens of Utah,” he told us. To allay safety concerns, he envisions the bill would require prescription medicines to be approved by regulators in both Canada and the U.S.
“And the bill would establish a chain of custody just like we have for U.S. distribution,” he said. “It shouldn’t be a significant cost to the state to set up a program, fill out paperwork and get approval (from the U.S. Human and Health Services secretary). According to federal law, that’s the only approval we need.”
Even so, the move is likely to receive considerable pushback.
In general, importation sparks debate that Americans could be exposed to counterfeit medicines.
Last year, four former Food and Drug Administration commissioners penned an open letter arguing against importation, citing such concerns. And the pharmaceutical industry has regularly lobbied against any and all efforts to allow importation. Over the years, Congress has failed to pass various bills that were proposed. And more than a decade ago, several states pursued web sites to allow residents to purchase medicines from Canada, but those efforts eventually sputtered, as well.
“Good luck with this. No HHS Secretary of either party has ever declared that importation is safe,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by the pharmaceutical industry.
“We have a closed regulatory system. Health Canada may be world class, but it doesn’t mean we can have multiple standards for drug approvals. What matters is how a drug is manufactured, stored, and dispensed. It sounds easy, but is extraordinarily hard.”
For his part, Thurston is doggedly optimistic.
In this instance (as it generally is with schemes to advance importation, “doggedly optimistic” = “deaf and dumb to reality.”
Let’s cut right to the chase. Generic drugs (85% + of all medicines volume in the US are LESS expensive than in Canada or any European country. Next, for the overwhelming number of Americans with private health insurance, the co-pays for their products are LESS expensive then buying them retail at either a brick-and-mortar of Internet Canadian pharmacy. Biologics? 85% of all biologics are administered in hospitals. Is Senator Sanders suggesting that American hospitals should import drugs that may or may not have been shipped under proper refrigeration conditions? FDA inspections speak otherwise.
The on-the-ground reality of state and local importation schemes has been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX” program? Over 19 months, only 3,689 Illinois residents used the program—that’s .02 percent of the population.
And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That’s in a state with a population of 5,167,101.
Remember Springfield, Massachusetts and “the New Boston Tea Party?” Well, the city of Springfield has been out of the “drugs from Canada business” since August 2006.
And speaking of tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city in the nation to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
The Canadian supplier for the program was Winnipeg-based Total Care Pharmacy. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.
Programs like this wouldn’t do any better on a national basis. A study by the non-partisan federal Congressional Budget Office showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1 percent—and that’s not including the tens of millions of dollars the FDA would need to oversee drug safety for the dozen or so nations generally involved in foreign drug importation schemes.
In addition to importing foreign price controls, Americans would end up jeopardizing their health by purchasing unsafe drugs while not saving money.
A better policy for our new President and Congress to focus on is the issue of increasing insurance company co-pays and co-insurance. Dropping drug co-pays would also help patients stick to their prescribed treatment regimes. All too often, people skip a dose, don’t get a refill, or stop taking their drugs prematurely in order to save money. In the long run, though, not adhering to a drug regimen leaves patients less healthy — and increases national medical expenses by an estimated $300 billion annually.
When consumers say, “My drugs are too expensive,” what they mean is that their co-pays and co-insurance are too expensive. And they’re right. Major insurance companies and pharmacy benefit managers (PBM) receive significant discounts from the manufacturers. So why doesn’t this result in lower co-pays for consumers? That’s a good issue for our new political leadership to debate – both in Salt Lake City and Washington, DC.
Seeking a way to alleviate high drug prices, a Utah lawmaker hopes to introduce a bill that would allow the state to import prescription medicines from Canada, a move that is likely to accelerate a fierce debate over drug costs and patient safety.
Over the next several weeks, Rep. Norman Thurston, a Republican, plans to submit legislation to authorize state officials to designate an existing pharmaceutical wholesaler to purchase prescription drugs from a wholesaler in Canada. His hope is that retail pharmacies based in Utah would then be able to buy and sell medicines at lower prices.
“We’re still trying to work out some of the details, but we envision a safe supply chain that would result in significant cost savings for the citizens of Utah,” he told us. To allay safety concerns, he envisions the bill would require prescription medicines to be approved by regulators in both Canada and the U.S.
“And the bill would establish a chain of custody just like we have for U.S. distribution,” he said. “It shouldn’t be a significant cost to the state to set up a program, fill out paperwork and get approval (from the U.S. Human and Health Services secretary). According to federal law, that’s the only approval we need.”
Even so, the move is likely to receive considerable pushback.
In general, importation sparks debate that Americans could be exposed to counterfeit medicines.
Last year, four former Food and Drug Administration commissioners penned an open letter arguing against importation, citing such concerns. And the pharmaceutical industry has regularly lobbied against any and all efforts to allow importation. Over the years, Congress has failed to pass various bills that were proposed. And more than a decade ago, several states pursued web sites to allow residents to purchase medicines from Canada, but those efforts eventually sputtered, as well.
“Good luck with this. No HHS Secretary of either party has ever declared that importation is safe,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by the pharmaceutical industry.
“We have a closed regulatory system. Health Canada may be world class, but it doesn’t mean we can have multiple standards for drug approvals. What matters is how a drug is manufactured, stored, and dispensed. It sounds easy, but is extraordinarily hard.”
For his part, Thurston is doggedly optimistic.
In this instance (as it generally is with schemes to advance importation, “doggedly optimistic” = “deaf and dumb to reality.”
Let’s cut right to the chase. Generic drugs (85% + of all medicines volume in the US are LESS expensive than in Canada or any European country. Next, for the overwhelming number of Americans with private health insurance, the co-pays for their products are LESS expensive then buying them retail at either a brick-and-mortar of Internet Canadian pharmacy. Biologics? 85% of all biologics are administered in hospitals. Is Senator Sanders suggesting that American hospitals should import drugs that may or may not have been shipped under proper refrigeration conditions? FDA inspections speak otherwise.
The on-the-ground reality of state and local importation schemes has been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX” program? Over 19 months, only 3,689 Illinois residents used the program—that’s .02 percent of the population.
And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That’s in a state with a population of 5,167,101.
Remember Springfield, Massachusetts and “the New Boston Tea Party?” Well, the city of Springfield has been out of the “drugs from Canada business” since August 2006.
And speaking of tea parties, according to a story in the Boston Globe, “Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city in the nation to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few dozen participants.”
The Canadian supplier for the program was Winnipeg-based Total Care Pharmacy. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.
Programs like this wouldn’t do any better on a national basis. A study by the non-partisan federal Congressional Budget Office showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1 percent—and that’s not including the tens of millions of dollars the FDA would need to oversee drug safety for the dozen or so nations generally involved in foreign drug importation schemes.
In addition to importing foreign price controls, Americans would end up jeopardizing their health by purchasing unsafe drugs while not saving money.
A better policy for our new President and Congress to focus on is the issue of increasing insurance company co-pays and co-insurance. Dropping drug co-pays would also help patients stick to their prescribed treatment regimes. All too often, people skip a dose, don’t get a refill, or stop taking their drugs prematurely in order to save money. In the long run, though, not adhering to a drug regimen leaves patients less healthy — and increases national medical expenses by an estimated $300 billion annually.
When consumers say, “My drugs are too expensive,” what they mean is that their co-pays and co-insurance are too expensive. And they’re right. Major insurance companies and pharmacy benefit managers (PBM) receive significant discounts from the manufacturers. So why doesn’t this result in lower co-pays for consumers? That’s a good issue for our new political leadership to debate – both in Salt Lake City and Washington, DC.
