FDA Enhances Pathway to Import Prescription Drugs From Canada

The FDA announced enhancements to the pathway for the import of certain prescription drugs from Canada aimed at significantly reducing the cost of those drugs to American consumers.

• Agency to offer individual states and tribes the opportunity to submit a draft proposal for pre-review and meet with the agency to obtain initial feedback from FDA prior to submitting section 804 importation program proposal
  • Actions aimed at clarifying requirements and enhancing the quality of proposals submitted to the FDA, shortening the review timeline
• Agency working to assist states with options to streamline required cost savings analysis
• NOTE: Drugmakers Avoid Worst-Case Scenario ...