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

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.

A Colorado Woman Was Seriously Ill. No One Suspected Her Imported Drugs.

February 5, 2019

In this February 4th, 2019 editorial for Colorado Politics, Denver resident Ali Schroer warns, “I experienced firsthand the dangers of counterfeit, imported drugs, and was critically ill for months as we sought to uncover the source of my illness.”

Importation is “extremely dangerous idea,” says former FBI Director Freeh

January 31, 2019

In this editorial, which first appeared in The Washington Times on January 29, 2019, former FBI Director Louis J. Freeh revisits the problem drug importation poses to law enforcement and regulatory systems already overburdened by the opioid crisis.

National Association of Manufacturers Exec warns, “Importation Proposals Disguise Serious Risks”

January 31, 2019

In this January 30, 2019 editorial, which was published in the National Association of Manufacturer’s Shopfloor blog, Vice President of Infrastructure Robyn Boerstling warns that even though legislators have good intentions, importation could “result in disastrous outcomes.”

Importation Is Too Risky, Warns Former FDA Associate Commissioner

January 23, 2019

In a January 23, 2019 editorial published in The Hill Peter Pitts, a former FDA associate commissioner and the president of the Center for Medicine in the Public Interest, explains why the safety risks of importation far outweigh any savings.

Side Stepping FDA Safeguards to Buy Medicine in Mexico Isn’t Safe, Former DEA Agents Warn

December 10, 2018

In this editorial, which was published in The Salt Lake Tribune on December 10, 2018, former DEA agents Javier Peña and Steve Murphy, warn that importing prescription drugs from other countries is “an extremely risky enterprise with potentially tragic consequences.”

Former Ontario Police Superintendent Warns That Gang-Backed Fentanyl Trafficking Threatens both Canada and the U.S.

November 20, 2018

In this editorial, which appeared in Inside Sources on November 20, 2018, former chief superintendent of the Ontario Provincial Police Don Bell discusses the threat that gang-backed fentanyl trafficking poses to the U.S. and Canada, and emphasizes the importance of working together to secure the border.

Congress Passes Opioid Epidemic Legislative Package

October 17, 2018

The Partnership for Safe Medicines applauds the passage of the SUPPORT Act, an $8 billion package which will help develop non-addictive painkillers, improve prescription drug monitoring programs, establish comprehensive opioid recovery centers, and strengthen Customs and Border Protection’s ability to intercept fentanyl that is illegally shipped into the United States.