Weekly Policy Update: FDA Moves Forward with Final Rule on Drug Importation

Yesterday the FDA issued their final rule and guidance on the importation of prescription drugs. They were first proposed last December, and CBSA worked with other state bioscience associations to submit comments in opposition. We are still reviewing the final regulation and guidance, but we remain concerned that importation schemes would jeopardize patient safety and do little to reduce out-of-pocket costs for Colorado consumers.

The final rule issued this week implements a provision of the Federal Food, Drug, and Cosmetic Act to allow the importation of certain prescription drugs from Canada. Under the rule, states, Indian tribes, and in certain circumstances pharmacists and wholesalers, may submit importation program proposals to the FDA for review and authorization. The rule contains the requirements necessary for a sponsor to demonstrate that their importation program will pose no additional risk to the public’s health and safety. It also requires that the sponsor explain how they will ensure their program will result in significant savings for the American consumer. The final rule will take effect in 60 days.

The final guidance for industry describes procedures drug manufacturers can follow to facilitate importation of 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 foreign country. Note: In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

What does this mean for Colorado?

In 2019, the Colorado state legislature passed Senate Bill 005, which requires the Colorado Dept. of Health Care Policy and Financing (HCPF) to submit a request to the U.S. Dept. of Health and Human Services (HHS) for approval of a program to import prescription drugs from Canada.

In March of this year, HCPF submitted comments to HHS in response to the federal proposed rule and a draft application for Colorado’s Drug Importation program. In their comments, the department outlined a series of changes they wanted to see in the final rule that would allow them to successfully implement an importation program in Colorado. While the final rule acknowledges some of those comments, many of the issues raised by HCPF are not fully addressed.

HCPF is hosting a webinar for stakeholders on October 15 from 9:30 – 11:00 a.m. to review the draft application and discuss recent developments, which will likely include discussion of the final rule and its impact on the program in Colorado. CBSA will be participating in the meeting, and we will keep our community updated on any outcomes and next steps.

Categories: CBSA News