PSM Statement on Florida’s Submission of Irresponsible Drug Importation Concept Document

WASHINGTON (August 26, 2019) – Shabbir Imber Safdar, Executive Director of The Partnership for Safe Medicines, released the following statement in response to Florida’s submission of a drug importation concept to the U.S. Department of Health and Human Services (HHS):

“Florida’s Canadian Prescription Drug Importation Concept Paper [PDF] recently submitted to HHS demonstrates that Florida is unprepared to keep patients safe from counterfeits under a reckless importation scheme. The proposal is sloppy, irresponsible and politically-motivated. Rather than advancing the concept of importation, it shows that the state is absolutely not ready to be a pilot project for importation.

“For example, one of the drugs identified to be imported from Canada (diclegis for pregnancy nausea) is often replaced by two generic medicines that are widely and cheaply available today in the U.S. It would be cheaper and safer to continue with this standard practice than attempting to import the branded medicine from Canada.

“Two other medicines (Vimpat [1] and Isentress[2]) on the proposed list for importation have been in short supply in Canada in the last 24 months.  Canadian authorities have thus far refused to cooperate with Florida’s importation program due to shortages and they are unlikely change their mind at this stage. It’s impossible to execute a program – even an unsafe one – without Canadian participation.

“If implemented, Florida’s importation proposal would target and victimize the state’s most vulnerable populations, including indigent women and children, prisoners, Medicaid recipients, and people with disabilities. These Floridians don’t have the freedom to choose an alternative supply chain and will pay for the mistakes made.

“Finally, Florida legislators promised that any importation scheme would comply with  the Drug Supply Chain Security Act, which requires that medicine be tracked from factory floor to pharmacy. However, Florida’s concept paper suggests that slapping a bar code on a medicine after it has changed hands an unknown number of times by unregulated vendors satisfies the requirements of U.S. law. It does not. This is the ultimate betrayal of our nation’s track and trace system.

“We will continue our effort to ensure that Floridians are not put in harm’s way to accommodate a short-sighted political agenda.”

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