Savings Not Likely in FDA Drug Import Proposal: Analysis
Manatt Health senior advisor Ian Spatz says the FDA proposal to create a process for agency approval of state-sponsored drug importation plans is not likely to generate significant savings for states or even enough to justify the cost of establishing such a program. Writing online in Stat, Spatz says that FDA has long maintained that there is no way to open a drug channel into the U.S. pharmaceutical supply chain without violating the 2003 law requiring HHS certification that importation would not pose a public health safety risk.
“With a heavy twist of the arm from President Trump’s strong support for importation,” he writes, “FDA has been forced to describe a possible pathway for it.” Spatz notes that importation really has not been about actually bringing drugs into the U.S., but rather bringing in the prices paid for those drugs in other countries.
The FDA proposal released 12/2019 involves a “detailed, complex, step-by-step process that a state would need to follow if it wishes to import drugs for its Medicaid and other state programs, or for use by private health plans,” Spatz writes. “To do its best to ensure safety, FDA proposes allowing only the shortest possible supply chain: manufacturer to exporter to importer to patient. While that makes sense, it also creates a practical problem for the program’s success: Why would a manufacturer sell its drug to anyone who is going to ship it into the U.S. and undercut its prices here?”
Spatz also says that Canada is not likely to participate in a plan that could reduce access to drugs for its own citizens and probably would not grant required exporting licenses to companies participating in the U.S. program.
The post also questions the potential financial success of the proposal given the many duties that an importer would have to agree to.
Spatz concludes that if drug importation is not the answer to high drug prices, it will continue to fall to Congress and the White House to see if an agreement is possible on any of the current proposals for the U.S. to deal directly with prices “rather than delegating that role to our neighbors to the north.”