Drugs

Trump Proposes Some Drug Imports from Canada

President Donald Trump and HHS are proposing a rule that, if finalized, would allow the importation of certain prescription drugs from Canada. The administration also announced a draft guidance with procedures drug manufacturers could follow to facilitate importation of prescription drugs, including biologics, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.

The proposed rule would allow states and other non-federal government entities to submit importation proposals to FDA for review and authorization. The rule says an importation program could be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal government entity.

The programs would be authorized by FDA to manage the importation of certain prescription drugs that are approved in Canada and also meet the conditions in an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required U.S. labeling before importation and have to undergo testing for authenticity, degradation, and to ensure that the drugs meet established specifications and standards. The programs would also have to demonstrate significant cost reductions to American consumers.

Comments are being received on the proposal.

Observers have noted that it may be difficult for potential programs to meet the plan’s requirements and also have indicated that Canada has expressed reluctance to see many of its prescription drugs exported to the U.S. and potentially shortchanging its own citizens.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome