Instituting new policies and regulations and passing legislative reforms to protect and expand safe prescription drug importation will mean much lower drug prices for Americans.
The big pharmaceutical companies already make most of their prescription drugs outside the U.S. and import them, but charge much higher prices for those same drugs here than where they are made. New channels of safe importation will give Americans direct access to the lower drug prices in other countries.
In the short term, safe personal drug importation must be protected and expanded through judicious use of enforcement discretion and the creation of waiver programs to expressly permit the practice. In the longer term, Congress must pass legislation to allow wholesale drug importation beyond Canada to the European Union and other nations with equivalent regulatory regimes.
Many Americans already import lower-cost prescription drugs and should be able to do so when they cannot afford them domestically and it is not an unreasonable risk.
Safe personal importation pathways should be clarified, protected, and expanded through patient-centered enforcement policies, instead of impeded by destroying prescription orders at international mail facilities.
Enforcement discretion to permit personal drug importation is not enough.
The FDA should issue waivers under 21 U.S.C. § 384(j)(2) to grant advance and express permission to safely fill prescription drug orders internationally.
Americans have been traveling to Canada for decades to obtain more affordable and safe prescription drugs or order them online.
They should be able to access those same lower prices at their local pharmacies. These programs have faced structural headwinds but have reinforced that wholesale drug importation can be done with no additional risk to the public health.
Canada is too small for a sustainable and long-term wholesale importation channel.
It can help with substantial savings on some drugs, but it cannot supply lower-cost drugs in the quantities necessary to fill the affordability gap.
Canada can help, but it cannot sustainably supply lower-cost drugs in the quantities necessary to meet America’s prescription drug affordability needs.
Congress must pass legislation to allow for the wholesale importation of lower-cost prescription drugs from the European Union and other high-income countries with strong systems of drug supply chain safety.