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

Letter from HHS Secretary Alex Azar to House Minority Leader Kevin McCarthy certifying the final rule on wholesale Canadian drug importation, September 23, 2020.

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.…

PSM Coverage:

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

New Analysis by HDA Finds Importation Proposals Are Too Expensive and Pose Health Risks to Patients

July 16, 2019

National Pharmacy Organizations Ask HHS Secretary Azar for Clarity on Drug Importation Proposals

June 28, 2019

New PSM ad reminds us that politics should never take precedence over safety when it comes to medicine.

June 12, 2019

PSM responds to AMA resolution #129 (A-19) on Mexico drug importation – June 9, 2019

June 10, 2019

Florida Agency for Health Care Administration releases Request for Information for Canadian Prescription Drug Importation Program

May 29, 2019

Husband of Former Pennsylvania Township Commissioner Charged in Fake Online Pharmacy Case

May 20, 2019

Former FDA Commissioner Scott Gottlieb condemns importation proposals and points out Florida’s sordid history with wholesale counterfeit drugs

May 10, 2019

Partnership for Safe Medicines’ Statement in Response to President Trump’s Comments on Foreign Drug Importation

May 10, 2019

New Mexico Pharmacists Association Expresses Concern Over Allowing Drug Importation In Letter to Congress

April 30, 2019

Politifact ignores the world of criminal counterfeiters

April 25, 2019

New PSM ads highlight concerns of FDA Commissioner Gottlieb about the dangers of Florida’s importation legislation

April 19, 2019

North Carolina Man Who Imported Counterfeit Xanax from Canada Sentenced to 2 Extra Days in Prison in Sled Border-Crossing Case

April 10, 2019