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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:

We believe the next step for HHS will be a Notice of Public Comment and additional development of regulations around importation programs.

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

Economist questions the fundamentals of importation: “It flunks a basic policy analysis.”

April 29, 2019

In this editorial published on April 26, 2019, Douglas Holtz-Eakin, economist and President of American Action Forum, questions economic truths about drug importation:

“Drug reimportation has long been the fool’s gold of health policy, and the Florida bill is no different. It flunks a basic policy analysis. But most amazing, it is drafted to raise hope, but not actually help Floridians.”

Journalist on drug importation: “There is a real risk.”

April 28, 2019

In this piece published in the Washington Free Beacon on April 25, 2019, staff writer Charles Fain Lehman explores issues around Florida’s drug importation proposal. “Critics,” he notes, “fear that the actual realities of regulatory oversight—especially in the hand of an as-yet-unnamed private vendor—will simply be too challenging to manage responsibly.”

Utah pharmacist and state senator: Importation raises “serious concerns about drug safety”

April 27, 2019

In this piece, which was published in The Deseret News on April 24, 2019, pharmacist and Utah State Senate Majority Leader Evan Vickers raises serious concerns about importation as a strategy to lower drug prices:

“Anyone who truly understands how drugs are sold and distributed in the U.S. knows that there are very solid technical reasons that such importation is not viable. There are also serious concerns about drug safety, since the CHS cannot guarantee origin and purity on foreign-sourced drugs.”

The Bottom Line? “Importation will make it difficult to ensure that Floridians are receiving real and safe medicine.”

April 26, 2019

In this piece, which was published on the ABC affiliate WJLA’s website on April 25, 2019, political analyst Boris Epshteyn explains that “this is a risky plan that will make it difficult to ensure that Floridians are receiving real and safe medicine.”

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.”

PSM's Statement on Proposed Regulations to Import Prescription Medicines from Canada

"Citizens of the United States and Canada should be outraged that the Trump Administration has prioritized politics over their own health and safety..."

Read more, and track policymaker response to HHS's proposal.


PSM Coverage:

What Canadians Are Saying About Drug Importation, January – December 2019

December 18, 2019

HHS Announces Dangerous Draft Regulations for Importing Drugs from Canada

December 18, 2019

PSM’s Executive Director Speaks on Morning Wakeup with Dave Akerly to Warn Michigan Residents about the Dangers of Drug Importation

December 5, 2019

Canadian Doctors, Pharmacists, Patient Groups and Government Representatives Consider State Importation Proposals Unfeasible

November 21, 2019

How do you test whether a medication is legitimate?

October 23, 2019

PSM, Partners Host Fall 2019 Congressional Briefings About Counterfeit Drug Dangers

October 3, 2019

Myth: We are getting the same drugs Canadians take

September 30, 2019

Shepherd M (2019) New pathways for U.S. importation threaten Canadian prescription drug supply. Canadian Health Policy Journal,

September 23, 2019

Drug Importation By the Numbers

August 28, 2019

PSM Statement on Florida’s Submission of Irresponsible Drug Importation Concept Document

August 25, 2019

Senator McSally Meets with Experts on the Counterfeit Drug Trade

August 14, 2019

Canadians Concerned About US Prescription Drug Importation Proposals

August 8, 2019

Prime Minister Trudeau Promises to Protect the Canadian Drug Supply In The Face Of The U.S. Drug Importation Statement

August 1, 2019

Partnership for Safe Medicines Statement on Reckless and Politically-Motivated Federal Drug Importation Proposal

July 31, 2019

ASOP Canada and 14 Other Canadian Patient Organizations Raise Alarm with Canadian Minister of Health on U.S. Drug Importation Proposals

July 30, 2019
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