Eakinomics:
Floridian Drug Reimportation — The Wrong Prescription
Today the Florida Senate votes on a bill to allow drugs to be reimported
to Florida from Canada, which has attracted the support of
Republican Governor Ron DeSantis. For years politicians
and activist groups have advocated for purchasing drugs in lower-cost
foreign jurisdictions to be distributed to U.S. patients, despite
lingering uncertainty over safety, administrative feasibility, and
economic viability. The fuzzy thinking transcends the ideological
spectrum so that even some conservatives and Republican-controlled state
legislatures are supportive.
Drug reimportation has long been the fool’s gold of health policy, and
the Florida bill is no different. It flunks
a basic policy analysis. But most amazing, it is drafted to raise hope,
but not actually help Floridians.
What’s wrong with Florida reimporting drugs? Start with safety. An
informed voice is former Food and Drug Administration Commissioner Scott
Gottlieb, who recently tweeted: “The drug importation
scheme contemplated by Florida is especially ill advised when considered
against that state’s long history…of being home to importation ‘front
groups’ supplying drugs of troubling origin, quality, and
legitimacy.”
Florida is also large enough (27 million people) that it runs right into
the fundamental inconsistency in the reimportation argument. Why would
Canada, after negotiating lower-cost prescription drugs for its 31
million citizens, give them up for Floridians to have them? It will not
subject its citizens to higher prices or rationing. Expect passage of
reimportation legislation to spur an instant legislative response in
Ottawa.
At the same time, it makes no sense for U.S. drug manufacturers to enter
into contracts with Canada that contain enough surplus supply to permit
shipments back into Florida (or any other state). They will simply not
aid and abet undercutting their basic business model.
Reimportation does not make good policy sense from either a safety or
economic perspective, but the Florida law is more baffling yet. First, it
is hard to imagine large numbers lining up to participate. Canadian
suppliers would have to comply with all Canadian and U.S. laws, as would
U.S. importers. As a nod to safety and supply chain
concerns, their actions would be coordinated by a vendor that would
be liable for illegal activity by participants and the safety of the
drugs.
The regulatory compliance burden will be quite onerous and costly, not
just for the program participants but for the state as well. Each
supplier and importer will be required to obtain a permit from the state,
and the legislative text detailing the application and permitting process
is 25 pages. Documentation must be provided for every single batch of
drugs imported. Sampling of every batch of drugs will be required to
ensure its safety and effectiveness and that the quality of the drug has
not degraded from the time it was manufactured. Inspections of
participating facilities will be required.
Second, the restrictions on the types of drugs essentially rule out
success. The law states that “Importing the drug is expected to generate
cost savings” but also that “The drug is not: 1. A controlled substance
as defined in 21 U.S.C. s. 802; 2. A biological product as defined in 42
U.S.C. s. 262; 3. An infused drug; 4. An intravenously injected drug; 5.
A drug that is inhaled during surgery.” In other words, the law allows
importation of few of the drugs that have generated controversy over high
drug prices.
Reimportation is a perennial in political campaigns but has never become
the law of the land because it will not work. In fact, the Secretary of
Health and Human Services already has the authority to permit
reimportation if it is safe, yet no secretary ever has. The Florida
proposal inherits the fundamental flaws of the idea and makes them worse.
I blame the heat.
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