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# PhRMA Petitions to Stop Drug Import Program
- URL: https://www.fdaweb.com/phrma-petitions-to-stop-drug-import-program/
- Published: 2020-12-02T12:00:00.000Z
- Updated: 2026-09-14T16:38:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148213

A citizen petition submitted on behalf of Pharmaceutical Research and Manufacturers of America (PhRMA) calls on FDA and HHS to take several steps to stop the drug import program recently announced by the Trump administration. PhRMA was one of three groups that recently filed [suit](https://www.fdaweb.com/3-groups-sue-to-block-drug-import-rule/) in federal court to block the program that would allow states to set up programs in which some drugs could be imported from Canada as a way to reduce drug costs.

In its [petition](ttps://www.regulations.gov/contentStreamer?documentId=FDA-2020-P-2236-0001&attachmentNumber=1&contentType=pdf), PhRMA asks that the two agencies: 

- discontinue implementation efforts, including withdrawing the Request for Proposals Regarding Waivers for Individual Drug Importation Plans and refrain from approving any individual waiver importation plans; or
- refrain from granting waivers to authorize personal importation unless and until HHS **(1)** certifies to Congress after an appropriate notice and comment proceeding that the importation poses no additional risk to the public’s health and safety and results in a significant reduction in the cost of covered products to the American consumer; **(2)** publishes a final guidance describing the circumstances under which the HHS secretary will grant case-by-case waivers before issuing any such waiver; **(3)** grants case-by-case waivers to individuals solely in compliance with statutory requirements applicable to personal importation under the Federal Food, Drug, and Cosmetic Act; **(4)** follows the appropriate due process procedures for informal adjudications under the Administrative Procedure Act; and **(5)** publishes notice of any approvals of any individual drug importation plans or grants of case-by-case waivers immediately upon issuance.

PhRMA says the Individual Waiver Importation Plan program “constitutes a significant departure from requirements of both the Federal Food, Drug, and Cosmetic Act and the Administrative Procedure Act. One of the departures, it says, is that HHS has expressly declined to certify the personal importation provisions, and lacks any factual basis to do so.