Following through on President Trump's Executive Order in July aimed at cutting U.S. drug costs via importation, the FDA issues its final rule on allowing agency-authorized programs to import medicines, including biologics, from Canada under certain conditions that ensure safety.
The guidance describes procedures drug makers can follow, including obtaining a National Drug Code (NDC), to facilitate the importation of prescription drugs and biologics that are FDA-approved, manufactured abroad, authorized for sale in any foreign country and originally intended for sale in that foreign country.
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 labeling, meet the conditions of an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required U.S. labeling 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.
FDA Commission Stephen Hahn, M.D., says, "Today's action is an important part of the 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. 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."
Selected tickers: Pfizer (NYSE:PFE), Eli Lilly (NYSE:LLY), Merck (NYSE:MRK), Bristol Myers Squibb (NYSE:BMY), Novartis (NYSE:NVS), Johnson & Johnson (NYSE:JNJ), Roche (OTCQX:RHHBY), AbbVie (NYSE:ABBV), GlaxoSmithKline (NYSE:GSK), AstraZeneca (NYSE:AZN), Sanofi (NASDAQ:SNY), Teva Pharmaceutical Industries (NYSE:TEVA), Bausch Health Companies (NYSE:BHC), Takeda Pharmaceutical Company (NYSE:TAK)