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# Senators Question Drug Import Enforcement
- URL: https://www.fdaweb.com/senators-question-drug-import-enforcement/
- Published: 2018-01-02T12:00:00.000Z
- Updated: 2026-09-14T23:10:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140370

Sens. **Chuck Grassley** (R-IA) and **Amy Klobuchar** (D-MN) are asking FDA commissioner **Scott Gottlieb** whether the agency’s enforcement policies on prescription drugs imported from Canada has changed. The senators’ 12/21/17 [letter](https://www.grassley.senate.gov/news/news-releases/grassley-klobuchar-seek-answers-prescription-drug-importation-policies?ref=fdaweb.com) follows an 11/20/17 *Kaiser Health News* report that FDA sent Office of Criminal Investigation agents to nine Florida stores that help patients buy prescription drugs from Canadian pharmacies.

“It is our understanding that these stores solely assist patients who prefer to purchase prescription drugs from outside the United States, including by helping patients avoid Web sites that sell fraudulent or unsafe products, and do not dispense drugs themselves,” the senators wrote. “We are concerned that FDA may be taking actions to scale back the agency’s non-enforcement policy that currently allows for limited importation of prescription drugs.”

The senators have introduced the Safe and Affordable Drugs from Canada Act to allow for personal importation of prescription drugs from approved pharmacies in Canada for personal use with a valid prescription. The letter asks Gottlieb to endorse their bill to “demonstrate FDA’s commitment to lowering prescription drug prices in this country.”

Grassley and Klobuchar ask Gottlieb: 

- Has FDA changed the policy included in the 2016 Regulatory Procedures Manual regarding personal importation of safe prescription drugs from Canada?
- · If so, what is the current policy?
- Are there any barriers to the certification of importation of prescription drugs from Canada if **(1)** the drug is off patent or no longer marketed in the U.S. by the innovator company that initially developed the drug, **(2)** there are significant and unexplained price increases; **(3)** there is no direct competitor drug currently in the market and introduction of a competitor drug will lower the prices paid by taxpayers and consumers, or **(4)** the drug is produced in another country by the name brand manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the U.S.?