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# Mixed Views on Drug Import Rule
- URL: https://www.fdaweb.com/mixed-views-on-drug-import-rule/
- Published: 2020-03-11T12:00:00.000Z
- Updated: 2026-09-14T16:06:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146301

The Biotechnology Innovation Organization (BIO) says FDA should withdraw its proposed rule to allow the importation of some drugs from Canada “in recognition of the safety and cost hurdles” outlined in the association’s comments on the proposal. The BIO [letter](https://www.regulations.gov/document?D=FDA-2019-N-5711-1173&ref=fdaweb.com) says that importation is unlikely to materially affect the ongoing debate over drug pricing. “While importation sounds like a convenient and impactful tool in dealing with price concerns, in reality it is unlikely to yield any real savings to the American consumer,” the trade group says. “And what is more, full implementation is likely to raise more safety concerns than cost savings.”

In its [response](https://www.regulations.gov/document?D=FDA-2019-N-5711-1205&ref=fdaweb.com), the American Medical Association (AMA) says it supports efforts to import lower-cost prescription medications, so long as certain safeguards are in place to ensure product safety, quality, integrity, and authenticity. While the association says it welcomes FDA initiatives to explore allowing the importation of prescription drug products by wholesalers, pharmacies, and other entities, the proposal to create state-based programs to import prescription drugs from Canada “raises questions and serious concern that we urge FDA, as well as HHS, to consider prior to moving towards finalization.” The AMA says it supports the legalized importation of prescription drug products by wholesalers and pharmacies only if all the drug products are FDA-approved and meet all other FDA regulatory requirements, if the drug distribution chain is closed, and if all drug products are subject to reliable track and trace technology.

The United States Pharmacopeia (USP) [says](https://www.regulations.gov/document?D=FDA-2019-N-5711-1172&ref=fdaweb.com) the “current U.S. distribution system for prescription drugs ensures the quality and safety of medicines sold in the U.S. and is predicated on a strong foundation of FDA’s review and evaluation supported by the availability of USP’s quality standards. Allowing the importation of numerous prescription drugs into the U.S. makes the consistent application of FDA requirements and USP quality standards all the more important.”

Finally, the National Association of Chain Drug Stores [says](https://www.regulations.gov/document?D=FDA-2019-N-5711-1174&ref=fdaweb.com) it has “serious safety and operational concerns about commercial importation of pharmaceuticals. Multiple outstanding issues relating to cost, quality, and efficiency must be resolved before a commercial importation scheme can be successful.”