In 2004, Rhode Island became the first state to authorize its pharmacy board to license Canadian pharmacies to ship medications to its residents.
If a particular drug costs $5 at a pharmacy in Canada and $25 at a pharmacy in the United States, and is produced by the same manufacturer, why shouldn’t Americans be able to buy that drug from the most-affordable source?
States, insurers, consumer groups, and some politicians have been asking that question for decades, even more frequently as the cost of prescription medications continue to spiral upward.
Would foreign importation bring inferior products?
In 2004, Rhode Island became the first state to authorize its pharmacy board to license Canadian pharmacies to ship medications to its residents. A short-lived, state law allowed Canadian pharmacies that became licensed in Rhode Island to import their drugs.
The law drew sharp criticism from people concerned that importing drugs from Canada would open our markets to inferior products. “There will be little or no monitoring of those pharmacies as to whether they are transshipping products from outside Canada,” warned Carmen Catizone, then executive director of the National Association of Boards of Pharmacy.
Catizone conceded Canadian regulations were similar to those in the United States, but that the law offered no guarantee the imported drugs would come from countries where standards were not as high as those in Canada and the United States. “Rhode Island has thrown open the gate. They are eliminating state regulation and turning everything over to the country with the lowest prices. This approach is extremely dangerous and is certainly not in the best interests of the patients,” he said.
Another state tries and fails
Rhode Island may have been the first to try to skirt FDA regulations in search of more-affordable drugs. But it is not the only state to have tried and subsequently been blocked in its effort to import less-expensive drugs from outside the United States. In February 2015, a federal judge overturned a state law permitting Maine residents to buy prescriptions drugs from Internet pharmacies in Canada, the United Kingdom, Australia, and New Zealand.
A coalition that included the Maine Pharmacy Association (MPA), the Maine Society of Health-System Pharmacists, the Retail Association of Maine, and the Pharmaceutical Research and Manufacturers of America sued the state to overturn the law, contending it would usher counterfeit and expired medications into the state. U.S. Chief District Judge Nancy Torresen ruled the law infringed on the federal government’s regulatory authority.
“Singling out of certain countries from which pharmaceuticals may be imported compromises the tightly regulated [federal] structure,” Torresen wrote. “[It] compromises [the] federal government’s ability to speak with one voice when it regulates foreign commerce.”
Kenneth McCall, former president of the MPA, applauded the ruling. “Maine pharmacists are relieved that Judge Torresen’s ruling ensures the safety of prescription drugs for Mainers by upholding federal laws that are designed to prevent unapproved and substandard drugs from coming into the United States,” McCall said.
Are patients the real losers?
Not everyone was happy with the decision. has not announced if the state plans on appealing the decision. “Congress and the FDA should re-examine their policy towards importation of prescription drugs,” Maine Attorney General Janet Mills Mills said. “Meanwhile, we will review the decision and decide on next steps.”
Former Maine Sen. Troy Jackson added “some of these drugs are being made in Ireland. One day they’re going to Canada, the next day they’re going to the United States. It’s the same manufacturing facility.…The only thing that’s different is the price that they’re able to squeeze out of people in the United States.”
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
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