Trump Administration Defies 20 Years of FDA Expertise and Guidance in
Finalizing Politically Motivated Drug Importation Rule

Washington, D.C. (September 24, 2020) – Shabbir Safdar, executive director of the Partnership for Safe Medicines, released the following statement in response to the Trump Administration’s Final Rule issued today on the importation of prescription drugs:

“With 40 days to go before the election, the Trump Administration has found yet another way to put politics over the safety of Americans. In a desperate attempt to show progress on the issue of drug pricing, President Trump’s Food and Drug Administration finalized a dangerous and costly policy to import prescription drugs from Canada.

“With multiple former FDA Commissioners on record opposing drug importation after careful consideration (here and here), we can only conclude that this move is politically motivated. Importantly, the former Commissioners are not alone. Patient advocates, Canadian officials, law enforcement organizations, and many others have all expressed deep concern about the implications of mass importation of prescription medicines.

“The consensus is this: at best, allowing states to import prescription drugs from Canada does not lower the cost of medicines for anyone. At worst, it puts the lives of Americans at risk.

“Just as responsibility for the coronavirus pandemic response has been pushed down to the states, so too will the burden for implementing drug importation fall to our now cash-strapped states. Florida budgeted $10 million to get its own version of a drug importation plan up and running. Colorado has committed nearly $3 million and is no closer to finding Canadian wholesalers who will sell them drugs, securing approval from Canadian authorities or finalizing a reasonable plan to deliver savings. Other states are beginning to admit that the juice is just not worth the squeeze based on past attempts and current cost estimates to conceive, build, execute and maintain a drug importation program that keeps their citizens safe. When political posturing is removed from the equation, this drug importation policy simply does not add up.

“Let us remember, too, that Canadian officials have told us unequivocally that their country does not have the drug supply to satisfy the much larger U.S. market. It simply does not exist. Not only does this make the policy unworkable, but it also makes it dangerous. Smugglers and criminals will walk into the supply void happy to satisfy Americans’ need for medicines. One merely needs to look at how bad actors took advantage of COVID-19 to sell non-existent or low-quality personal protective equipment to know that states are not equipped to act as their own FDA. We cannot let that happen any time, but especially not now, during a pandemic that has already threatened the health of so many citizens.

“The Partnership for Safe Medicines will continue its work to educate federal and state officials and advocates of patient safety about the perils of drug importation so that American’s are not put in harm’s way.”

About the Partnership for Safe Medicines

The Partnership for Safe Medicines (PSM) is a public health group comprised of non-profit organizations that are committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard, or otherwise unsafe medicines. To learn more, visit www.safemedicines.org.

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