This ruling implements a provision of federal law that allows FDA authorized programs to import certain drugs from Canada under specific conditions to ensure that importation imposes no additional risk to public health and safety while achieving a significant reduction in the cost of covered products to America. The guidance describes the procedures drug manufacturers can follow to facilitate the importation of certain prescription drugs, including biological products that are FDA approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that country.
“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,” said FDA Commissioner Stephen M. Hahn, M.D. “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 rule allows states (including the District of Columbia and territories), Indian tribes and — in certain future circumstances — pharmacists and wholesalers, to submit importation program proposals to the FDA for review and authorization. An importation program can be co-sponsored by a state, Indian tribe, pharmacist or wholesaler. Referred to as Section 804 Importation Programs, these programs will be managed by the respective sponsor and any co-sponsors and authorized by the FDA to facilitate the importation of certain prescription drugs that are approved in Canada and, with appropriate labelling, meet the conditions of an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required U.S. labelling and undergo testing for authenticity, degradation and to ensure that the drugs meet established specifications and standards. These programs will also have to demonstrate significant cost reductions of the covered products to the American consumer.
The final guidance issued today describes procedures for a drug manufacturer to obtain a National Drug Code (NDC) for certain FDA-approved prescription drugs, including biological products and combination products, that were originally manufactured and intended for sale in that foreign country. The use of an additional NDC for these products may allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require. Prescription drugs, including biological products, imported under the pathway described in the final guidance could be available to patients in a variety of settings, including hospitals, health care providers’ offices or licensed pharmacies, and would include the FDA-approved labelling (including prescribing information).
