The FDA made the decision under section 804 of the Federal Food, Drug, and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada if the submitted program proposal to do so demonstrates significant cost savings for U.S. consumers while maintaining patient safety.
The decision comes after the state also filed a lawsuit against the FDA for alleging it was “recklessly” delaying the decision. Which is not the first time the state has been at odds with the agency.
“Florida has demonstrated that it meets the statutory obligation to ensure that importation under section 804 will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety,” a Jan. 5 letter from the FDA to Jason Weida, the secretary for the Florida Agency for Health Care Administration, reads.
Florida’s importation proposal will be authorized for two full years on the date it notifies the FDA of the first shipment to be imported, according to the news release. However, before it begins importing the cheaper medicines, the state must submit additional information about the drugs it wants to import, re-label drugs to be consistent with U.S. and FDA standards, test the drugs for authenticity and compliance, and submit reports quarterly to the FDA on the cost savings and safety.
The state previously estimated in the first year of the program alone that its savings would total $150 million. It is planning to import drugs for HIV, AIDS, psychiatric medications, hepatitis C and more, The New York Times reported.
Other states including Colorado, Texas, North Dakota, New Mexico, New Hampshire, Maine, Wisconsin and Vermont are also pursuing similar approvals from the FDA.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
