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HHS's Federal Action Plan for Drug Importation, 2019

Synopsis:

On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced that it was working on potential avenues for the importation of foreign prescription drugs:

  • Inviting states, wholesalers and pharmacists to submit proposals for pilot projects to import FDA-approved drugs from Canada, following guidance (still forthcoming) based on Section 804 of the Food, Drug and Cosmetic Act.
  • Advising manufacturers of FDA-approved drugs about how to sell Americans versions of those drugs they have manufactured for foreign markets.

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

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.

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.

PSM Coverage:

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

Things we learned from sending a Freedom of Information Act request to Florida’s healthcare agency implementing importation

July 24, 2019

Medical Device King Exec Takes a Plea Deal Instead of a Retrial; Gets 32 Months in Prison

July 17, 2019
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