Will some states begin importing low-costing prescription drugs from Canada?

"before drugs can be imported, Florida’s Agency for Health Care Administration must:

• Submit additional drug-specific information for the FDA's review and approval
• Ensure that the drugs Florida seeks to import have been tested for, among other things, authenticity  and compliance with the FDA-approved drugs’ specifications and standards
• Relabel the drugs to be consistent with the FDA-approved labeling

In addition, Florida’s Agency for Health Care Administration must submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues." 

"To reduce the cost of covered products [prescription drugs] to the American consumer without imposing additional risk to public health and safety, the Commissioner of Food and Drugs shall work with States and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173, 117 Stat. 2066), and the FDA's implementing regulations."

The Secretary of Health and Human Services (Secretary) is issuing a final rule to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada.  Under this final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit importation program proposals to the Food and Drug Administration (FDA, the Agency, or we) for review and authorization.  An importation program may be cosponsored by a State, Indian Tribe, pharmacist, or wholesaler.  The final rule contains all requirements necessary for a sponsor to demonstrate that their importation program will pose no additional risk to the public’s health and safety.  In addition, the final rule requires that the sponsor explain how they will ensure their program will result in a significant reduction in the cost of covered [prescription drug] products to the American consumer. [emphasis added]

"The final [FDA drug importation] regulation will allow specific drugs to be imported, as long as they meet federal standards for safety and saving money. Though the rule goes into effect in 60 days, HHS officials could not say when actual importation plans would take effect.  The [drug importation] plan has faced strong objections from the Canadian government and drugmakers, which have said they will go to court to prevent the regulation from taking effect." [emphasis added]