July 23, 2018
Alex Azar, the US Health and Human Services (HHS) Secretary, stated that the administration may allow for drug importation but only in certain circumstances. Azar has asked the FDA Commissioner, Scott Gottlieb, to establish a working group to investigate how the “safe” importation of drugs from other countries could be guaranteed.[^1](In other words, how to guarantee the drugs are coming from Canada and not from some counterfeit factory across the ocean.)
Right now, the HHS is saying this would only apply to drugs that have had “significant price increases or access challenges for patients”. As well, this proposal would only include drugs unprotected by patents or exclusivities and only where drugs can be imported with adequate assurances of safety and effectiveness. Azar emphasized the proposal will not apply to a broader category of drugs. The ultimate goal of the HHS is not to open the door for more importation but to generate multiple versions of these essential drugs within the US to increase access for FDA-approved drugs.[^2]
*This announcement was carefully crafted to show the HHS is not unconditionally changing their tune, but may temporarily allow a diversion to avoid situations where patients have to pay a 500% or 5,000% increase for their much needed drug because there is no other option. BUT, what will happen when the border door legally opens and the Canadian solution to high US drug prices is just too enticing to confine to just those few drugs??
As always, a Cross-Border Allocation Program is recommended if the price of your product in Canada < U.S.*
For more information, please contact Marla Weingarten.