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# Scholars Question FDA Drug Importation Rule: Report
- URL: https://www.fdaweb.com/scholars-question-fda-drug-importation-rule-report/
- Published: 2020-11-12T12:00:00.000Z
- Updated: 2026-09-14T16:36:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148073

A Council on Foreign Relations working paper says that a recent FDA rule to encourage drug importation from Canada won’t reduce drug prices or increase the volume of imported drugs. An analysis of the working paper in an online *Regulatory Review* [post](https://www.theregreview.org/2020/11/12/dinapoli-fda-importation-prescription-drugs/?ref=fdaweb.com) from the University of Pennsylvania Law School says the new rule creates a program under which states and wholesalers can request permission to import prescription drugs from Canada under the 2003 Medicare Prescription Drug, Improvement, and Modernization Act (MMA).

“The authors criticize FDA’s new rule,” the analysis says, “because it attaches a host of procedural costs for applicants that defeat the stated goal of reducing costs for consumers. For example, the MMA requires the HHS secretary to certify that importation will result in savings for consumers, but the rule shifts the burden of certification onto applicants through post-importation disclosures. The complexity of the application process may ultimately destroy any benefit to consumers, creating uncertainty for applicants before they can even begin to import drugs and show consumer savings.”

The *Regulatory Review* post notes that President **Donald Trump** signed an executive order in July directing HHS secretary **Alex Azar** to finish the rulemaking process for creating the importation program as well as to exercise FDA’s limited discretion in granting individual exceptions to the prohibition on importing drugs.

The final rule takes effect 11/30, it says, and FDA will publish further guidance for applicants at a later date.