Comment to FDA on Draft Guidance for Importation of Certain Drugs | Citizens Against Government Waste

Comment to FDA on Draft Guidance for Importation of Certain Drugs

Agency Comments

February 21, 2020

Food and Drug Administration
Dockets Management Staff (HFA-305)
5630 Fishers Lane, Rm. 1061,
Rockville, Md. 20852

Docket No. FDA-2019-D-5743

Draft Guidance: Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry


Citizens Against Government Waste (CAGW) is a private, nonpartisan, nonprofit organization representing more than one million members and supporters nationwide.  CAGW's mission is to eliminate waste, mismanagement, and inefficiency in the federal government.  CAGW was founded in 1984 by the late industrialist J. Peter Grace and syndicated columnist Jack Anderson to implement the recommendations of President Ronald Reagan’s Private Sector Survey on Cost Control, also known as the Grace Commission.


For 20 years, the Food and Drug Administration (FDA) has refused to certify the safety of imported drugs.  The agency decided it was impossible to determine if the drugs were safe, consumers were being misled importation would save money, and it would open the door for devious individuals to manufacture counterfeit, adulterated, and dangerous drugs and infiltrate them into the supply chain.

Our concerns regarding the draft guidance are laid out in the attached comment to FDA here.

Issues Topics: 

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