FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

OMB Reviewing Proposed Drug Importation Rule

Nov. 14, 2019
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HHS submitted its proposed rule on prescription drug imports — a key part of the  administration’s strategy to lower drug prices — to the Office of Management and Budget (OMB) for review.

Details of the proposal have not yet been released, but it is expected to align with the action plan released by HHS and FDA in July that suggests two pathways for drug imports.

The first would allow states, wholesalers and pharmacists to submit plans to the FDA for importing prescription drugs approved by Health Canada. The second would allow manufacturers of FDA-approved drugs to import versions of the drugs they sell overseas into the U.S., as long as they are identical.

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