Trump Administration To Release Drug Importation Guidance Soon

Drugmarkers may be allowed to import their own products under different drug code
Robert Calandra

The Trump administration’s rules and guidance on drug importation policy is expected to be released this week, according to Politico and Modern Healthcare.

Politico's Dan Diamond reported this week that the White House’s budget office has alerted groups that the rules had cleared review.

Rachel Chors at Modern Healthcare reported that the PhRMA and the Partnership for Safe Medicines, groups that opposed importation, were told their January meetings have been canceled because the budget office said the rules and guidance were no longer under review.

What it all means, Diamond reported, is that the administration will lay out a method to implement a provision in a 2003 law that allows the importation of medicines  if the HHS  certifies that the drugs are both safe and will lead to lower costs.


Chors reported that the rules and guidance will follow an "action plan" released by HHS Secretary Alex Azar this summer. That plan mapped about two possible "pathways" for drug importation: States would import drugs from Canada and drugmakers could import their own products and sell them under different drug codes.

According to Diamond and others, the political motivation behind the drug importation policy is the desire for a message that the administration has taken steps to rein in drug prices. Drug pricing legislation in Congress has stalled so a legislative win is not in sight. Meanwhile, Florida, a swing state, has been pushing to import more drugs from Canada.

But questions remain about how much impact importing drugs will have on prices. Drug-pricing experts have serious doubts it will, reported Diamond.