Pharmacy groups are speaking out against a final rule from the FDA and HHS that allows importation of prescription drugs from Canada, which the White House claims will bring Americans savings for their medications.
The American Pharmacists Association said that the rule, which was published Sept. 25, jeopardizes patient safety by creating supply chain vulnerabilities that could introduce counterfeit or unsafe drugs.
“APhA is disappointed that FDA would risk the safety and security of our nation’s drug supply by creating a complex and convoluted program allowing legal importation of certain drugs from Canada. We believe FDA’s new drug importation program is not a safe way to reduce drug prices—and puts patients at risk,” the group said in a news release.
APhA also said the act undermines the Drug Supply Chain Security Act by creating supply chain disruptions and product selection confusion that may limit patients’ access to drugs and complicates insurance coverage and pharmacy reimbursement.
Tom Kraus, vice president of government relations for the American Society of Health-System Pharmacists, told Drug Topics it is “deeply concerned that allowing wholesale importation of drugs will punch a massive hole in our nation’s drug supply chain, exposing patients to risks and potentially undermining an expensive track-and-trace system that’s in the midst of implementation. We are strongly supportive of efforts to reduce drug pricing, but not if, like importation, they come at the expense of patient safety with no guarantee of meaningful cost savings over the long term.”
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