Skip to content

HHS's Federal Action Plan for Drug Importation, 2019

Synopsis:

On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced that it was working on potential avenues for the importation of foreign prescription drugs:

  • Inviting states, wholesalers and pharmacists to submit proposals for pilot projects to import FDA-approved drugs from Canada, following guidance (still forthcoming) based on Section 804 of the Food, Drug and Cosmetic Act.
  • Advising manufacturers of FDA-approved drugs about how to sell Americans versions of those drugs they have manufactured for foreign markets.

Current status:

We believe the next step for HHS will be a Notice of Public Comment and additional development of regulations around importation programs.

What you can do now:

Because these programs have never sustainably saved money, and have endangered Americans every time they've been attempted, PSM is taking a number of actions to fight for patient safety. As we develop opportunities to speak up for safety, we'll put these here.

How should we evaluate this program?

Until July 2019, every head of Health and Human Services and the FDA since 2003 has refused to certify the safety of drug importation. Many—including Alex Azar, former FDA Commissioner and Trump appointee Scott Gottlieb, and his four immediate predecessors—have explicitly criticized these proposals as unsafe, unimplementable, and unlikely to save money.

HHS and FDA hasn't implemented its proposals yet so there's no way to evaluate whether they save money or keep patients safe. However previous programs in Maine, Illinois, and Minnesota all shut down because they didn't save the money promised. They all had safety lapses as well.

Planning documents

HHS/FDA announces the Safe Importation Action Plan. July 31, 2019

Section 804 of the Food, Drug and Cosmetic Act which outlines the method by which the Federal government may import medicine from Canada.

Background / resources

Just learning about foreign drug importation proposals? Start with some of these resources that outline the safety issues.

PSM Materials:

Challenges to importation:

Coverage:

 

Op-eds from the Experts

A Colorado Woman Was Seriously Ill. No One Suspected Her Imported Drugs.

February 5, 2019

In this February 4th, 2019 editorial for Colorado Politics, Denver resident Ali Schroer warns, “I experienced firsthand the dangers of counterfeit, imported drugs, and was critically ill for months as we sought to uncover the source of my illness.”

Importation is “extremely dangerous idea,” says former FBI Director Freeh

January 31, 2019

In this editorial, which first appeared in The Washington Times on January 29, 2019, former FBI Director Louis J. Freeh revisits the problem drug importation poses to law enforcement and regulatory systems already overburdened by the opioid crisis.

National Association of Manufacturers Exec warns, “Importation Proposals Disguise Serious Risks”

January 31, 2019

In this January 30, 2019 editorial, which was published in the National Association of Manufacturer’s Shopfloor blog, Vice President of Infrastructure Robyn Boerstling warns that even though legislators have good intentions, importation could “result in disastrous outcomes.”

Importation Is Too Risky, Warns Former FDA Associate Commissioner

January 23, 2019

In a January 23, 2019 editorial published in The Hill Peter Pitts, a former FDA associate commissioner and the president of the Center for Medicine in the Public Interest, explains why the safety risks of importation far outweigh any savings.

Side Stepping FDA Safeguards to Buy Medicine in Mexico Isn’t Safe, Former DEA Agents Warn

December 10, 2018

In this editorial, which was published in The Salt Lake Tribune on December 10, 2018, former DEA agents Javier Peña and Steve Murphy, warn that importing prescription drugs from other countries is “an extremely risky enterprise with potentially tragic consequences.”

Former Ontario Police Superintendent Warns That Gang-Backed Fentanyl Trafficking Threatens both Canada and the U.S.

November 20, 2018

In this editorial, which appeared in Inside Sources on November 20, 2018, former chief superintendent of the Ontario Provincial Police Don Bell discusses the threat that gang-backed fentanyl trafficking poses to the U.S. and Canada, and emphasizes the importance of working together to secure the border.

Congress Passes Opioid Epidemic Legislative Package

October 17, 2018

The Partnership for Safe Medicines applauds the passage of the SUPPORT Act, an $8 billion package which will help develop non-addictive painkillers, improve prescription drug monitoring programs, establish comprehensive opioid recovery centers, and strengthen Customs and Border Protection’s ability to intercept fentanyl that is illegally shipped into the United States.

Pharmacist and Drug Safety Advocate Urge HHS to Consider the Dangers of Importation

October 17, 2018

In this October 16, 2018 for Drug Topics, Alliance of Safe Online Pharmacies advisor Libby Baney and pharmacist and American Pharmacists Association CEO Thomas Menighan discuss the risks to public safety posed by drug importation.

Importation Has Some Huge Risks

September 5, 2018

There are certainly things we can learn from other countries’ healthcare successes, but importation is not the right approach.

Discussing the Difficulty of the Import Problem

September 4, 2018

This distressing situation shows that deadly fentanyl analogues are killing Americans who are using laced non-opioid prescriptions.

PSM Coverage:

PSM’s Executive Director Speaks on Morning Wakeup with Dave Akerly to Warn Michigan Residents about the Dangers of Drug Importation

December 5, 2019

Canadian Doctors, Pharmacists, Patient Groups and Government Representatives Consider State Importation Proposals Unfeasible

November 21, 2019

How do you test whether a medication is legitimate?

October 23, 2019

PSM, Partners Host Fall 2019 Congressional Briefings About Counterfeit Drug Dangers

October 3, 2019

Myth: We are getting the same drugs Canadians take

September 30, 2019

Shepherd M (2019) New pathways for U.S. importation threaten Canadian prescription drug supply. Canadian Health Policy Journal,

September 23, 2019

Drug Importation By the Numbers

August 28, 2019

PSM Statement on Florida’s Submission of Irresponsible Drug Importation Concept Document

August 25, 2019

Senator McSally Meets with Experts on the Counterfeit Drug Trade

August 14, 2019

Canadians Concerned About US Prescription Drug Importation Proposals

August 8, 2019

Prime Minister Trudeau Promises to Protect the Canadian Drug Supply In The Face Of The U.S. Drug Importation Statement

August 1, 2019

Partnership for Safe Medicines Statement on Reckless and Politically-Motivated Federal Drug Importation Proposal

July 31, 2019

ASOP Canada and 14 Other Canadian Patient Organizations Raise Alarm with Canadian Minister of Health on U.S. Drug Importation Proposals

July 30, 2019

Things we learned from sending a Freedom of Information Act request to Florida’s healthcare agency implementing importation

July 24, 2019

Medical Device King Exec Takes a Plea Deal Instead of a Retrial; Gets 32 Months in Prison

July 17, 2019
Scroll To Top