There was a flood of media coverage following the FDA’s announcement that they have approved Florida’s request to import low-cost drugs from Canada. While that may bode well for many patients, one needs to dig a bit deeper to understand whether this decision will be a golden egg for specialty pharmacies.
It is highly likely that other states will quickly jump on this band wagon…. especially since it reads well in political press releases. But, it does not look all that promising for SPs.
The FDA approval requires a ‘plan’ that includes a host of compliance requirements…. and a few exclusions. The exclusions are what tosses a wet blanket on the opportunity for SPs.
Here is where the blanket gets wet…..
Florida must implement its plan in compliance with the requirements of the Department of Health and Human Services’ Safe Importation Action Plan, which was finalized in 2020.
The plan specifies that the following categories are excluded:
- biological products
- drug with a REMS
- infused drugs / intravenously injected drugs
- controlled substances
- drugs inhaled during surgery, and
- certain parenteral drugs
What appears to be absent in the plan, however, are subcutaneously/IM/etc. administered, non-biologic drugs. Hmmmmm?
It will be interesting to see if this slice of opportunity is worth the effort for SPs to pursue participation.
FDA Authorizes Florida’s Drug Importation Program