HHS's Federal Action Plan for Drug Importation, 2019

Synopsis:

On December 18, 2019, the U.S. Department of Health and Human Services (HHS) released proposed regulations for importation by pharmacists and wholesalers (Pathway #1) or by manufacturers (Pathway #2).

Current status:

HHS's comment period for RIN 0910-AI45 ended on March 9th. Read PSM's summary of the results here.

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.

Planning documents

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

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.

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.