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

The case against importation: “There are simply too many channels for fake drugs to enter any importation scheme”

April 23, 2019

In this piece, which was published in the Inside Sources on April 22, 2019, Michael Graham reviews the case against drug importation: “As Scott Gottlieb said in 2016 before becoming President Trump’s FDA chief…’There are simply too many channels for fake drugs to enter any importation scheme to forgo some meaningful controls.’”

Oncology Practice Managers: This “drug importation proposal that could put Floridians at risk”

April 22, 2019

In this editorial, which was published in the Palm Beach Post on April 22, 2019, Michelle Flowers writes about Florida’s history of black market cancer treatments and the danger importation poses to patients. Flowers is president of the Oncology Managers of Florida.

Santa Cruz Sentinel logo

Importation “Too Good to Be True, ” Business Columnist Warns

April 19, 2019

In this editorial, which was published in The Santa Cruz Sentinel on April 18, 2019, business columnist Jeffrey Scharf argues that importation of prescription drugs is a plan that is too good to be true.

Head of Patient Advocacy Organization Warns That Drug Importation Is Not The Solution American Patients Need

April 18, 2019

In this editorial by Terry Wilcox published in Inside Sources on April 18, 2019, Terry Wilcox, executive director of a patient advocacy organization advices federal and state representatives that allowing drug importation is not the right policy solution for America’s high prescription drug prices…

Canadian law enforcement: Smugglers will exploit importation to traffic counterfeit medicine

April 17, 2019

In this editorial, which was published in Colorado Politics on April 17, 2019, Don Bell, a 30-year veteran of Canadian law enforcement and border protection, warns that Canadian drug importation will open the U.S. to counterfeit medicine and exacerbate drug shortages in Canada.

The Wall Street Journal’s Editorial Board Comes Out Against Drug Importation

April 15, 2019

The editorial board of the The Wall Street Journal published this editorial on April 15, 2019. In it, they write:

“The argument that drug importation threatens the integrity of the drug supply is often dismissed because pharmaceutical lobbyists make it. But keeping the drug supply free from contaminated or counterfeit products is not easy, and the World Health Organization has warned that 1 in 10 medical products in the developing world are phony. It isn’t clear who is liable if counterfeits are found in Florida, but you can bet it won’t be the politicians.”

Drug importation makes law enforcement’s job harder, says former FDA-OCI director

April 11, 2019

In this editorial, which was published in The Gadsden Times on April 11, 2019, former FDA-OCI director George Karavetsos points out the real dangers of drug importation:

“Even today, Americans are being hurt and even dying because of counterfeit medications being imported into this country. Adding insult to injury, while some might point to Canada as being a safe source, counterfeit medications are transshipped through Canada from other countries in remote corners of the globe.”

Tampa Pharmacist Speaks Out Against Florida’s Drug Importation Proposal

April 3, 2019

This editorial by Dan Fucarino was published in Florida Politics on April 1, 2019. Mr Fucarino is the owner and a pharmacist at Carrollwood Compounding Center & Pharmacy.

“The monetary rewards of Canadian prescriptions are just not worth their safety risks,” he warns. “I urge Florida legislators to listen to health care experts on this issue rather than the understandable populist appeals and vote no on this dangerous legislation — and then get back to working on more productive ways to lower drug prices for Floridians. Thousands of Americans have been injured or killed by imported prescription drugs.”

Amelia Arnold, pharmacy operations manager for Community Pharmacies, Augusta, ME

Maine Pharmacist to Colorado: We found that importation doesn’t deliver quality or savings

March 29, 2019

In this March 28, 2019 editorial for the La Junta Tribune-Democrat, Maine pharmacist Amelia Arnold explains her state’s experience with drug importation: “It is a concept that makes big promises in terms of quality and cost savings that it cannot, and will not, deliver on for the people of Colorado.”

Sheriff of Larimer County, Colorado: Importing prescription drugs could be dangerous

March 23, 2019

These dangerous drugs get trafficked into Colorado and present a clear and present danger to unsuspecting citizens, who can die from simply ingesting what they think are safe medications. Importing foreign drugs would open a loophole, which increases the chance these dangerous counterfeits enter America unbeknownst to us all.