Bringing more drug competition to the market and addressing the high cost of medicines is a top priority of the Administration, the Department of Health and Human Services (HHS), and FDA. In July 2019, FDA announced the Safe Importation Action Plan that outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets.
This page features news and information about the Safe Importation Action Plan, FDA efforts and accomplishments under the plan, and related updates. Additional Resources are also included.
- In December 2019, FDA issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada.
- In December 2019, FDA announced the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
Further information on the Administration’s plan for bringing down the high price of drugs and reducing out-of-pocket costs for the American consumer, as well as additional details on FDA’s Safe Importation Action Plan, is available at the links below.
- Safe Importation Action Plan
- Notice of Proposed Rulemaking: Importation of Prescription Drugs
- Draft Guidance: Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act
- Safe Importation Action Plan Implementation
- Generic Competition Associated with Lower Prices
- HHS: Drug Pricing
- HHS Announces New Action Plan to Lay Foundation for Safe Importation
- Trump Administration’s Blueprint to Lower Drug Prices
- Advancing Patient Care Through Competition
- Capturing the Benefit of Competition for Patients
- FDA Tackles Drug Competition to Improve Patient Access