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

Pacific Research Institute CEO Begs Florida to Keep Counterfeit Drugs out of The State

March 20, 2019

Counterfeits coming from Canada have been a big issue in the Sunshine State. The FDA has identified dozens of counterfeit drugs coming into Florida from foreign pharmacies.

Pharmacist, educator and PSM board member speaks out against drug importation in Florida

March 20, 2019

“Several other states have attempted to legalize drug importation, but all have failed to show that it’s safe or saves money. The federal government has determined multiple times that drug importation can’t be done safely. I hope, for the sake of Floridians, that state policymakers come to that same conclusion.”

Gregg Keller, source: Gage Skidmore, via Wikimedia Commons

Former Executive Director of the American Conservative Union believes importation will hurt Americans

March 12, 2019

In this editorial, published in The Missouri Times on March 11, 2019, Gregg Keller warns that “the issue at hand is not so much the safety of Canadian drugs but the dangers of the global drug trade. Often, pharmacies that claim to be “Canadian” are anything but.”

National Association of Manufacturers Exec Warns that Florida’s Importation Plan Sacrifices Safety

March 7, 2019

In this March 5, 2019 editorial, published on the National Association of Manufacturers blog, Robyn Boerstling, the organization’s Vice President of Infrastructure, Innovation and Human Resources Policy, raises concerns about Florida’s drug importation proposal.

HIV-Positive Advocate Reminds Americans About the Dangers of Imported Drugs

March 6, 2019

It isn’t just policymakers who believe drug importation will open the U.S. drug supply to counterfeits. In this editorial, published in the Times of Northwest Indiana on March 6, 2019, HIV-positive advocate Brandon Macsata explains that his own physician objected to ordering medicine from Canadian online pharmacies:

“It never crossed my mind that I might have been taking counterfeit medicine, or that the medicines meant to control my HIV could be compromising my immune system. So when my doctor found out, she told me to stop immediately. She warned me that online pharmacies often sell counterfeit drugs.”

Canadian And American Pharmacists Associations Jointly Warn Against Drug Importation Policies

February 28, 2019

The Canadian Pharmacists Association (CPhA) and the American Pharmacists Association (APhA) have issued a joint statement in opposition to U.S. federal legislation authorizing personal and commercial importation of prescription drugs from Canada.

“While we recognize the desire to address affordability issues in the U.S.,” they write, “we strongly oppose the importation of prescription drugs from Canada because of the risks these policies pose to patient safety and
continuity of care.”

Drug importation will “jeopardize the health and well-being of millions of Americans,” Pacific Research Institute CEO warns

February 7, 2019

In this editorial, which was published in The Des Moines Register on February 7, 2019, Pacific Research Institute CEO Sally Pipes explains why drug importation is not the right way to lower costs.

A Colorado Woman Was Seriously Ill. No One Suspected Her Imported Drugs.

February 5, 2019

In this February 4th, 2019 editorial for Colorado Politics, Denver resident Ali Schroer warns, “I experienced firsthand the dangers of counterfeit, imported drugs, and was critically ill for months as we sought to uncover the source of my illness.”

Importation is “extremely dangerous idea,” says former FBI Director Freeh

January 31, 2019

In this editorial, which first appeared in The Washington Times on January 29, 2019, former FBI Director Louis J. Freeh revisits the problem drug importation poses to law enforcement and regulatory systems already overburdened by the opioid crisis.

National Association of Manufacturers Exec warns, “Importation Proposals Disguise Serious Risks”

January 31, 2019

In this January 30, 2019 editorial, which was published in the National Association of Manufacturer’s Shopfloor blog, Vice President of Infrastructure Robyn Boerstling warns that even though legislators have good intentions, importation could “result in disastrous outcomes.”