HHS's Federal Action Plan for Drug Importation, 2019

Synopsis:

On September 24, 2020, the federal government released a Final Rule Canadian drug importation (pathway 1), as well as Industry Guidance 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.

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.

RIN: 0910-AI45

Official actions and statements

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

“…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.…

photo of Ujjal Dosanjh

Canadian drug importation is “an economic fantasy,” former Canadian health minister says.

March 2, 2020

In this editorial in The Globe and Mail, Ujjal Dosanjh, formerly a federal minister of health and a premier of British Columbia, explains that drug manufacturers have no incentive to sell Canadian provinces more medicine to fill the needs of U.S. residents. Importation will lead to drug shortages in Canada and counterfeit drug trafficking to the U.S.

Canadian health law experts predict: Canada won’t end up as the drugstore to the U.S.

January 16, 2020

This editorial by David C. Rosenbaum and Dara Jospé was published in the Financial Post on January 16, 2020. Rosenbaum is a partner of the law firm Fasken. Jospé is an associate for the same company.

Photo of Salt Lake County Sheriff Rosie Rivera

Lowering prices “must not happen at the expense of public safety,” Utah sheriff says

December 3, 2019

This editorial by Rosie Rivera was published in The Salt Lake Tribune on December 3, 2019. Rivera is the sheriff of Salt Lake County.

photo of the author, C. Michael White

Pharmacy professor: buying prescription drugs from Canada “risky in terms of quality and safety”

September 27, 2019

This editorial by C. Michael White was published in The Conversation on September 27, 2019. White is a professor and head of the Department of Pharmacy Practice for the University of Connecticut.

Cancer Center Pharmacist in Iowa Worries Drug Importation Will Harm His Patients

August 27, 2019

This editorial by Dana McDougall was published in The Waterloo Cedar Falls Courier on August 26, 2019. Mr. McDougall, Pharm.D., BCPS, is a pharmacist with the Covenant Cancer Treatment Center in Waterloo, Iowa.

Canadian Physician Warns that American Drug Importation is Bad for Canada

August 13, 2019

This editorial by Dr. Charles S. Shaver was published in The Hamilton Spectator on August 11, 2019. Dr. Shaver i a practicing physician in Ottawa. He is a graduate of Princeton University and Johns Hopkins School of Medicine. Dr. Shaver is also past chair of the section on general internal medicine of the Ontario Medical Association.