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

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.

Economist Warns that Federal Drug Importation is Folly

August 7, 2019

This editorial by Wayne Winegarden, Ph.D. appeared in Forbes on August 7, 2019. Dr. Winegarden is the Managing Editor for EconoSTATS and a senior Fellow in Business and Economics at the Pacific Research Institute.

Policy Expert: “Even if Canada were a willing participant, the U.S. can’t ensure the safety of these drugs.”

August 7, 2019

In this editorial, which was published in The Washington Examiner on August 5, 2019, Pacific Research Institute CEO Sally Pipes explains that ” importing prescription drugs would put our lives in danger.”

Importation Won’t Save Money, warn Citizens Against Government Waste

August 2, 2019

In this July 31, 2019 blog post on the Citizens Against Government Waste (CAGW) website, CAGW Director of Health and Science Policy Elizabeth Wright questions the questions the effectiveness and safety of government importation schemes.

Drug Distribution Experts Warn That State Plans To Import Foreign Drugs Will Undermine Safety

July 11, 2019

This editorial by Adam Fein and Dirk Rodgers was published in Stat News on July 11, 2019. In it, Fein and Rodgers warn that plans by states to create drug importation programs will open new pathways for counterfeit drugs to enter the U.S. drug supply chain…