Jan. 5, 2024 – U.S. regulators on Friday accepted a plan to permit Florida to import medicines, describing this as a step towards permitting the state to buy medicines immediately from Canada at a decrease value.
The FDA licensed Florida’s Company for Well being Care Administration’s drug importation program. The state should subsequent fulfill a number of obligations, together with displaying that the medication it seeks to import have been examined for, amongst different issues, authenticity and compliance with FDA specs and requirements, the company mentioned.
That is the primary approval of a state drug importation plan. It marks a win for lawmakers in each events who’ve for a few years seen Canadian drug importation as a option to scale back U.S. pharmaceutical prices. Backers of this idea embody each Democrats, like President Joe Biden and U.S. Sen. Elizabeth Warren of Massachusetts, and Republicans, like former President Donald Trump and Florida Gov. Ron DeSantis.
However pharma teams within the U.S. vowed to struggle the plan.
In a Friday assertion, the commerce group for drugmakers, Pharmaceutical Analysis and Producers of America (PhRMA) mentioned it’s contemplating “all choices” for blocking Florida’s plan to import medicines from Canada.
And it’s unclear how effectively state drug importation plans would work out in observe in the event that they go into impact.
Canadian officers and medical organizations have lengthy objected to the concept of large importation into the US. For instance, the Canadian Pharmacists Affiliation in 2020 warned the FDA in the course of the Trump administration that such a diversion of its medicines could be “devastating” to a nation, aggravating drug shortages and rising drug prices.
Many individuals within the U.S. already make journeys to Canada and Mexico in the hunt for decrease costs.
The FDA has been working for years on rules to permit broader drug imports. The company in 2022 rejected a request from New Hampshire, citing an absence of key data, together with particulars on the anticipated provider of the medicines. Different states the place lawmakers have significantly thought of drug importation embody Colorado, Maine, New Mexico, Ohio, and Vermont, in accordance with a December 2023 report from the Texas Well being and Human Providers division.
In a Friday assertion, FDA Commissioner Robert M. Califf, MD, mentioned his company will work with different states and with Native American tribes on plans for importing medication.
“These proposals should exhibit the packages would lead to important value financial savings to shoppers with out including danger of publicity to unsafe or ineffective medication,” he mentioned in an announcement.
