HHS's Federal Action Plan for Drug Importation, 2019

Synopsis:

On September 24, 2020, the federal government released a Final Rule on Canadian drug importation (pathway 1), as well as Industry Guidance for manufacturer reimportation (pathway 2), and requests for proposals for waivers for individual prescription drug importation (pathway 3) and insulin reimportation programs (pathway 4) with an accompanying FAQ for the latter.

PSM, PhRMA, and CAHC have all filed suit against these regulations. You can read our joint announcement, our explainer about why we filed the litigation, and the complaint itself [PDF].

Current status:

The regulations are schedule for an effective date of November 30, 2020. PSM, PhRMA, and CAHC have filed suit in federal court to block them from taking effect.

On May 28, 2021 the Department of Health and Human Services filed a motion to dismiss the suit on the grounds that PSM, PhRMA, and CAHC did not have grounds to sue until the government had approved a state importation program.

PSM, PhRMA, and CAHC filed an amended complaint on July 2, 2021.

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 haven't implemented their 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.

Official Actions Since the Rule was Approved

June 1, 2021: Florida files an amicus brief in support of HHS's importation rule.

May 28, 2021: HHS files a motion to dismiss the suit.

November 23, 2020: PSM, Pharmaceutical Research and Manufacturers of American and The Council for Affordable Healthcare file a complaint alleging that the Final Rule disregards key protections of the Federal Food, Drug, and Cosmetic Act

Timeline of the approval of final rule for Canadian drug importation

September 24, 2020 - HHS published final rule for Canadian drug importation, as well as RFPs for personal importation waivers and and reimportation of insulin, and guidance for manufacturers who may choose to reimport their own drugs. (Links to those documents below, in Planning Documents.)

December 23, 2019 - March 9, 2020: HHS solicits comments about RIN 0919-AI45

July 31, 2019:

August 6, 2019:

August 20, 2019:

Fall 2019:

Planning documents

Pathway 1, Wholesale Canadian Drug Importation:  Final rule (PDF, 179 pages) and Redline (shows differences from December's draft rulemaking).

Pathway 2, Manufacturer Reimportation: Guidance for Industry

Pathway 3, Individual Waivers for Personal Importation: Request for Proposals

Pathway 4, Reimportation of Insulin: Request for Proposals and FAQ

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

Counterfeit HIV drug underscores risks of a weaker drug supply chain, advocate warns.

April 13, 2021

ADAP Advocacy Association CEO Brandon M. Macsata wrote this editorial, which appeared on the AIDS Drug Assistance Program’s website on April 1, 2021.

The Association first warned constituents that counterfeit Symtuza had been distributed to three U.S. pharmacies in December 2020, when Janssen issued an alert.

Canada’s Actions a Death-Knell for Drug Importation in Florida

December 9, 2020

This editorial by the Sun Sentinel Editorial Board was published in The Sun Sentinel on December 9, 2020. The Editorial Board consists of Editorial Page Editor Rosemary O’Hara, Dan Sweeney, Steve Bousquet and Editor-in-Chief Julie Anderson.   There Go Those Cheaper Drugs. Remember Florida’s plan to save money by importing prescription drugs in bulk from…

Canadian writer applauds country’s effort to protect its drug supply

December 4, 2020

This editorial by Joyce Nelson appeared in Counter Punch on December 4, 2020. Nelson is a researcher and writer whose work appears in a wide range of magazines, newspapers and websites.

Organizer explains why drug importation is dangerous and “doomed to fail”

December 4, 2020

This editorial, written by Earl D. Fowlkes Jr., appeared in the Washington Blade on December 4, 2020. Fowlkes is the president and CEO of the Center for Black Equity.

Importation was “a waste of valuable federal and state tax dollars,” says fiscally-focused advocacy group

December 4, 2020

In this editorial, which was posted on December 2, 2020, Citizens Against Government Waste decries the expense and futility drug importation.

picture of man at desk

“Reducing costs requires more than all of this non–value-added activity,” Expert Says

October 23, 2020

In this October 23, 2020 editorial, which was published in the The American Journal of Managed Care, Michael Abrams explains why drug importation will not save patients money. Abrams is the co-founder and managing partner of Numerof & Associates.

“…barriers will delay or prevent drug importation,” say regulatory experts

October 14, 2020

In this analysis, which was published in Lexology on October 13, 2020, three global regulatory experts examine barriers to drug importation.

Photo of patient advocate John Adams

Canadian patient advocate urges American friends to reject the “empty promises” of importation

August 14, 2020

In this August 14, 2020 editorial, Best Medicines Coalition chair John Adams explains why Canadian importation will not lower U.S. medicine prices—and why the “concept of cheap drugs from Canada has never been anything more than a political hallucination.”

Citizens Against Government Waste Warns Drug Importation Executive Orders Will Cost Patients in More Ways Than One

July 28, 2020

In this July 28, 2020 editorial published in the WasteWatcher blog, Elizabeth Wright argues that the administration’s Executive Order will “encourage more illegal behavior and a greater production of counterfeit drugs from countries like China, Mexico, and India.” Wright is the Director of Health and Public Policy for Citizens Against Government Waste

Executive Director of Colon Cancer Association Warns Against “Ill-Considered Drug Importation Scheme”

March 23, 2020

This editorial by Andrew Spiegel was published in The International Business Times on March 23, 2020. Mr. Spiegel is executive director of the Global Colon Cancer Association and Chair of the World Patient Alliance. President Trump, Price Controls Can’t Combat Coronavirus The U.S. outbreak of novel coronavirus, COVID-19, has quickly evolved into a national nightmare.…