HHS's Federal Action Plan for Drug Importation

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On May 24, 2022, PSM held an online congressional briefing with a panel of experts to let legislators know why drug importation is a dangerous proposition. Watch briefing highlights or the entire event.

Current status:

The regulations took effect on 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.

In the meantime, Colorado and Florida have submitted applications to begin state importation programs.

The State of Florida and Florida's Agency for Health Care Administration filed suit against the FDA and Department of Health and Human Services for delaying approval of its state importation program in August 2022.

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].

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

National Medical Association: “Minority Communities Need Better Health Care, Not Counterfeit Drugs”

June 26, 2017

On June 23, 2017, MorningConsult published this editorial by Garfield Clunie and Richard Williams. Clunie is the chairman of the board of the National Medical Association, a 501 (c) (3) nonprofit that represents African American physicians and their patients. Williams is the organization’s president.

State Boards of Pharmacy weigh in against importing drugs from Canada

June 21, 2017

Pharmacy boards, which ensure the safety of prescription medicines at the state level, have been sending letters to Congress to expressing significant safety concerns about legislation that would legalize drug importation.

First DHS Secretary: “It is too easy to ship deadly drugs in the mail”

June 21, 2017

The Salt Lake Tribune printed this editorial by Tom Ridge, the 43rd governor of Pennsylvania and first secretary of the U.S. Department of Homeland Security, on June 10, 2017. Ridge is currently a senior advisor to Americans for Securing All Packages (ASAP).

Health Policy Expert Declares Drug Importation “Unsafe, Unnecessary and Unwise”

June 9, 2017

This editorial was published by the Institute for Policy Innovation on June 5, 2017. Its author, Dr. Merrill Matthews, is a resident scholar with the Institute for Policy Innovation, a health policy expert and contributor at Forbes.com. He also serves on the Texas Advisory Committee of the U.S. Commission on Civil Rights.

A Patient Speaks Out: “Drug importation is dangerous.”

May 10, 2017

Ali Schroer wrote this editorial for the Washington Examiner on May 10, 2017.

Like millions of Americans, I take allergy medicine. A few years ago, my doctor urged me to bid farewell to my local pharmacy and instead buy my medication from an online Canadian drug store, where it was cheaper. What terrible advice! The website was counterfeit and sent me “medicine” that was anything but — causing me to get severely sick . . .

Hill Editorial Warns of Health Risks Resulting from Drug Importation Proposals

May 1, 2017

Ronald Piervincenzi, CEO of the U.S. Pharmacopeial Convention describes the dangerous flaws in any plan to open up U.S. borders to wholesale prescription medication importation from Canada.

Pew Trust Warns Senator Sanders that Drug Import Bill Could Compromise the Safety of the U.S. Drug Supply

March 14, 2017

On Tuesday, February 28, Allan Coukell, Senior Director of Health Programs for the Pew Charitable Trusts, wrote Senator Bernie Sanders to ask that he not undermine safety protections for medication with the Affordable and Safe Prescription Drug Importation Act.

The American Medical Association Opposes Drug Importation

December 13, 2016

In 2016, the American Medical Association reaffirmed its longheld  opposition to drug importation through two policy statements.  The first, “Prescription Drug Importation and Patient Safety D-100.983,” supports only the importation of FDA-approved medicines.  The second, “Federal Regulation and Computerized Tracking of Pharmaceuticals During Shipping and Handling from Manufacture Until Ultimately Received by Patient D-100.985,” promised to actively oppose drug diversion, illegal importation, and drug counterfeiting.

Anesthesiologist and AMA Board Trustee Testifies About the Dangers of Imported Drugs (2004)

May 14, 2004

In May 2004, anesthesiologist and American Medical Association trustee Rebecca J. Patchin, MD spoke before the Department of Health and Human Services Task Force on Drug Importation to express concern about the safety and reliability of imported drugs.

PSM Coverage: