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

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.”

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.”

PSM Coverage:

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

New Analysis by HDA Finds Importation Proposals Are Too Expensive and Pose Health Risks to Patients

July 16, 2019

National Pharmacy Organizations Ask HHS Secretary Azar for Clarity on Drug Importation Proposals

June 28, 2019