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HHS/FDA ADVANCE DRUG IMPORTATION WITH PROPOSED RULE

December 20, 2019 in Life Sciences News Public Policy by Denise Bell

On December 18, HHS and the FDA issued a Notice of Proposed Rulemaking (NPRM)  that would allow states to import prescription drugs from Canada. The proposed rule follows an Administration announcement in July that HHS would be examining pathways for safe drug importation. 

In a statement, HHS Secretary Alex Azar said “today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients.”

Under the proposed rule, importation programs could be submitted by states or certain non-federal entities for FDA approval. Pharmacists and wholesalers could co-sponsor importation programs. The rule also provides draft guidance to drug companies that want to bring drugs they sell at lower prices in other countries into the U.S. for sale to patients here. Although states such as Colorado, Florida, Maine and Vermont have passed drug importation laws, given the complexities around the issue, it could be years before any rule is finalized.

The Canadian government has been critical of the Administration’s plan, noting that importation could threaten the supply of Canadian drugs available to their own citizens. BioUtah, along with our national partners BIO and PhRMA, believe that drug importation is not a silver bullet for lower drug costs and could pose risks to patient safety. Colorado, Florida, Maine, Vermont 

Today’s issue of Policy and Medicine provides an overview of the proposed rule, describing the two pathways as well as industry reaction. Over the past couple of years, the Utah legislature has considered, but rejected drug importation legislation.