Canada drugs overview:
- Who: The Food and Drug Administration (FDA) authorized Florida’s Section 108 Importation Program plan to import a variety of prescription drugs from Canada.
- Why: The FDA drugs approval is part of President Joe Biden’s plan to promote drug price competition in the marketplace, the FDA said.
- Where: The Florida drugs approval came from the FDA’s Washington, D.C., office.
The Food and Drug Administration (FDA) granted approval to Florida’s plan to import a variety of prescription drugs from Canada, the first approval of its type.
The two-year approval begins when the FDA is notified of the first drug shipment. The FDA said the approval comes after President Joe Biden’s executive order to promote competition in the marketplace.
Florida’s Agency for Health Care Administration must first submit drug-specific information for FDA review and approval, ensure the imported drugs are tested for authenticity and compliance with FDA standards and must relabel the drugs with FDA-approved labeling.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Dr. Robert M. Califf said. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
Florida drugs plan will save state up to $180M annually, DeSantis says
Florida Gov. Ron DeSantis’ office said that it submitted its first application for the process 37 months ago and filed a lawsuit against the FDA related to delays. It estimated the first year of the program will save Florida up to $180 million in the first year.
“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” DeSantis said in a statement. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”
Florida will start with prescription drugs to treat HIV/AIDS, mental illness, prostate cancer and urea cycle disorder, it said. The drugs will be available for those under the care of the Agency for Persons with Disabilities (APD), Department of Children and Families (DCF), Department of Corrections (FDC) and Department of Health (DOH).
Florida hopes to then expand the program to include imported prescription drugs for Medicaid members.
The Biden administration proposed a new policy in December granting federal agencies march-in rights on taxpayer-funded drugs and inventions, opening the door for the government to seize patents for certain costly medications from drugmakers.
Have you ever purchased prescription drugs from Canada? Let us know in the comments.
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