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# Reject New Mexico Drug Import Proposal: Stakeholders
- URL: https://www.fdaweb.com/reject-new-mexico-drug-import-proposal-stakeholders/
- Published: 2021-03-23T12:00:00.000Z
- Updated: 2026-09-14T16:51:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148938

Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage are jointly asking FDA not to authorize the New Mexico Health Department’s Section 804 drug importation program application and to disclose the identities of the foreign seller, importer, and FDA-registered repackager or relabeler as well as the final list of drugs to be imported for public comment.

In their 3/18 [petition](https://www.regulations.gov/document/FDA-2021-P-0307-0001?ref=fdaweb.com), the three stakeholders say they filed an 11/23/20 suit challenging the HHS certification that a Section 804 drug importation program will not pose additional risk to the public health and safety and will result in a significant cost saving to consumers. They say the certification and HHS final rule are invalid for multiple reasons.

The petition says FDA is not authorized to approve the New Mexico application because the certification is invalid and the final rule is unlawful for reasons stated in the suit.

“New Mexico submitted a proposal so short on detail that FDA cannot assess whether the safety or cost criteria can be met,” the petition says. “New Mexico has not identified a foreign seller, importer, or FDA-registered repackager or relabeler, and it provides only the first iteration of the list of drugs to be imported. The application is so deficient on its face that we urge FDA to refuse to file it for review, much like it would for a new drug application that is deficient on its face in a way that precludes a complex review. Even if the application can be evaluated, it cannot be authorized because it fails to satisfy either of the primary criteria for authorization.”

In a 1/7 [petition](https://www.fdaweb.com/dont-authorize-florida-drug-import-program-petition/), the same stakeholders asked FDA not to authorize a Florida drug import proposal.