Four former commissioners of the Food and Drug Administration argue that consumer drug importation remains too risky to permit.
This article first appeared March 22, 2017 on Kaiser Health News.
By Rachel Bluth
With prescription drug prices soaring and President Donald Trump vowing to take action, an old idea is gaining fresh traction: allowing Americans to buy medicines from foreign pharmacies at far lower prices. A new bill in Congress to allow the practice would modify previous safety standards and remove a barrier that proved insurmountable in past attempts to enable progress.
Congress came close to allowing importation through the Medicare Modernization Act in 2003, but added one firm precondition that has prove a nonstarter. The secretary of Health and Human Services had to guarantee that imported medications posed no additional risk to public safety and would save money.
"That is a fairly absolute standard and a high bar to cross," said Elizabeth Jungman, director of public health at the Pew Charitable Trusts. Such an exacting standard — guaranteeing that no imported prescriptions posed a threat — has kept any secretary of HHS from condoning it.
In an open letter to Congress, four former commissioners of the Food and Drug Administration argue consumer drug importation remains too risky to permit. "It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs," they said in the letter distributed to media organizations. It was signed by Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach, who headed the FDA at various times between 2002 through 2016.
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.