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Proposed rule would allow states to import certain prescription drugs from Canada under conditions that pose no additional risk to patients.
Patients could be paying less for some prescription drugs thanks to a rule allowing drugs to be imported from Canada that is being proposed by the Trump administration, according to a news release from HHS.
The proposed rule lays out a plan to allow states and non-federal government entities to import certain FDA-approved prescription drugs from Canada. The administration also released guidelines for drug makers to import their products into the U.S.
Through the acceptance of these two releases, the administration hopes to lower drug prices for U.S. patients.
“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,” Alex Azar, HHS secretary, says in the release.
The programs would not include some of the most expensive prescription drugs, including insulin, due to a 2003 law limiting the types of drugs that could be imported, according to a New York Times report on the proposed rule.
This proposed rule would allow states and non-federal government entities to propose importation programs, that could be co-sponsored by a pharmacist or wholesaler, to the FDA for review and authorization. These plans would be authorized by the FDA to manage the importation of drugs that are approved in Canada and also meet the conditions in an FDA-approved drug application, the release says.
Importation programs would have to demonstrate significant cost reductions to American consumers. Eligible drugs would need to be relabeled with the required U.S. labeling before being imported and must undergo testing for authenticity, degradation, and to ensure that the drugs meet established specifications and standards, the release says.
“The FDA continues to assess and act on multiple opportunities to promote competition that can, in turn, help reduce drug prices and improve access to medicines for Americans,” says Assistant Secretary for Health Brett Giroir in the release. “The proposed rule and draft guidance include procedures intended to protect the public’s health and safety. We look forward to receiving public comment on these draft policies, and we will take timely comments into account as we work to finalize the rule and guidance.”
The draft guidance for drug manufacturers lays out a process for them to receive an additional National Drug Code for certain FDA-approved prescription drugs that were made and were intended to be marketed in a foreign country allowing the companies to offer them at lower prices than their current distribution contracts require, the release says.
Comments on the proposed rule will be accepted for 75 days after publication in the Federal Register and comments on the draft guidance will be accepted for 60 days after its publication on December 23. They can be made at regulations.gov.