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Tags: price | controls | counterfeit

Costly Imported Medicines Leave Patients Vulnerable

the risk of imported patient medicines


Sally Pipes By Tuesday, 19 September 2023 02:00 PM EDT Current | Bio | Archive

Imported Drugs Will Cost American Patients Dearly

Texas just became the latest state to look north for lower drug prices.

As of the beginning of this month, the state's Health and Human Services Commission gained authority to contract with Canadian wholesalers and suppliers to import prescription drugs from our northern neighbor.

The prices of brand-name prescription drugs are typically lower in Canada than in the United States. Proponents of drug importation intuitively argue that it will save U.S. patients money.

But the reality is more complex.

Canadians pay less for brand-name medicines because their government levies strict price controls on them.

Those price controls force patients to endure severe trade-offs, including drug shortages and long waits for access to the most innovative therapies.

Worse still, drug importation threatens to contaminate the U.S. drug supply with foreign medicines of questionable safety and quality.

President Trump opened the door to importation in his final months in office.

His plan allowed states to begin importing medicines from foreign wholesalers provided they first gained approval from the U.S. Food and Drug Administration.

Since then, a number of states — including Florida, Vermont, Wisconsin, and Colorado -- have passed laws creating drug importation programs. None has received a green light from the FDA.

Florida has grown so impatient that the state is suing the agency to speed things along.

But nobody should be in a rush to bring foreign drugs into their states.

First, there's the issue of safety.

As Donna Shalala, the Secretary of Health and Human Services (HHS) during the Clinton administration said in 2019, "No Health and Human Services secretary has ever approved the importation of drugs because of safety."

Proponents of importation often assume that medicines purchased from wholesalers or suppliers in other developed countries are of roughly the same quality as those on the U.S. market.

As Texas House member James Frank put it, "We’re not seeing, in Europe and Canada, people falling over because their drugs aren’t working."

But the global drug supply chain is complicated. The World Health Organization estimates that 1 million people die each year from counterfeit medicines.

According to the Pharmaceutical Security Institute, there were 6,615 incidents involving drug counterfeiting or other pharmaceutical crimes in 2022 alone — a 10% increase from the previous year.

Last month, Irish authorities announced that they'd seized nearly 300 units of black-market weight-loss drugs including Ozempic and Wegovy in the first seven months of 2023.

And just weeks ago, U.K. authorities charged five people with illegally operating websites supplying powerful epilepsy, anxiety, and pain medications.

And despite stringent regulation of what can enter the U.S. market, U.S. officials routinely uncover counterfeit medicines — everything from drugs for HIV and anxiety to painkillers.

Opening the U.S. market up to foreign-sourced drugs will offer bad actors a new way to get their illicit wares past overwhelmed U.S. regulators.

It's also worth noting that medicines that originate in Canada but are sold to Americans aren't subject to Canadian safety regulations.

Even if this weren't the case, Canada currently lacks the track-and-trace capabilities needed to guarantee the origins and chain of custody of drugs exiting crossing the border into America.

Further, there's no guarantee Canada will play along with state importation schemes. During a previous debate about importation back in 2005, Canadian Minister of Health Ujjal Dosanjh said, "Canada cannot be the drugstore for the United States of America."

Importation endangers the safety of patients today, and the health of patients tomorrow.

If Americans pay the artificially low prices that other governments have set for drugs in their countries, then pharmaceutical companies will lose out on revenue that funds research into the next generation of cures.

It may not be fair that Americans pay higher drug prices to underwrite the research and development that patients globally benefit from.

But that's no excuse to adopt foreign governments' price controls.

A better approach would be for the U.S. government to insist that other countries pay their fair share — perhaps by insisting on vigorous enforcement of intellectual property protections as a condition of trade agreements.

The states pressing for legalized drug importation are offering false hope to their constituents.

Drug importation will leave Americans needlessly vulnerable to dangerous — even life-threatening — counterfeit medicines, while making medical innovation unworkable, unprofitable, and a whole lot rarer.

Sally C. Pipes is president, CEO, and the Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is "False Premise, False Promise: The Disastrous Reality of Medicare for All," (Encounter Books 2020). Follow her on Twitter @sallypipes. Read Sally Pipes' Reports — More Here.

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Drug importation will leave Americans needlessly vulnerable to dangerous, even life-threatening, counterfeit medicines, while making medical innovation unworkable, unprofitable, and a whole lot rarer.
price, controls, counterfeit
Tuesday, 19 September 2023 02:00 PM
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