The Trump administration on Thursday unveiled its final rule allowing states to import some prescription drugs from Canada. FDA
The rule allows states and, under some circumstances, pharmacists or wholesale distributors to import drugs from Canada if their plan wouldn’t pose additional safety risks to the public and would save consumers a significant amount of money. The Food and Drug Administration would have to approve each plan. The rule goes into effect 60 days after it is published in the Federal Register.
“Today’s action is an important part of FDA’s priorities to promote choice and competition. The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve,” FDA Commissioner Dr. Stephen Hahn said in a statement. “The FDA will continue to assess and act on opportunities to increase competition in the prescription drug market and help reduce the cost of medicines.”
The agency also published final guidance to help drug manufacturers import their own FDA-approved prescription drugs, including biologics, made outside the U.S. for sale in other countries.
According to the rule, HHS was unable to estimate the rule’s cost savings because it didn’t have information about the likely size and scope of state importation plans, which drugs would be included, how much those drugs would cost or which domestic drugmakers make eligible drugs.
It also includes legal language that would essentially put an end to the program if a court struck down any part of it.
“The provisions of this part are not separate and are not severable from one another. If any provision is stayed or determined to be invalid or unenforceable, the remaining provisions shall not continue in effect,” the rule says.