HHS's Federal Action Plan for Drug Importation, 2019

Synopsis:

On September 24, 2020, the federal government released a Final Rule Canadian drug importation (pathway 1), as well as Industry Guidance manufacturer reimportation (pathway 2), and requests for proposals for waivers for individual prescription drug importation (pathway 3) and insulin reimportation programs (pathway 4) with an accompanying FAQ for the latter.

PSM, PhRMA, and CAHC have all filed suit against these regulations. You can read our joint announcement, our explainer about why we filed the litigation, and the complaint itself [PDF].

Current status:

The regulations are schedule for an effective date of November 30, 2020. PSM, PhRMA, and CAHC have filed suit in federal court to block them from taking effect.

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.

RIN: 0910-AI45

Official actions and statements

September 24, 2020 - HHS published final rule for Canadian drug importation, as well as RFPs for personal importation waivers and and reimportation of insulin, and guidance for manufacturers who may choose to reimport their own drugs. (Links to those documents below, in Planning Documents.)

December 23, 2019 - March 9, 2020: HHS solicits comments about RIN 0919-AI45

July 31, 2019:

August 6, 2019:

August 20, 2019:

Fall 2019:

Planning documents

Pathway 1, Wholesale Canadian Drug Importation:  Final rule (PDF, 179 pages) and Redline (shows differences from December's draft rulemaking).

Pathway 2, Manufacturer Reimportation: Guidance for Industry

Pathway 3, Individual Waivers for Personal Importation: Request for Proposals

Pathway 4, Reimportation of Insulin: Request for Proposals and FAQ

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

Former DEA Agent on how drug importation will exacerbate the opioid crisis

May 31, 2019

Former DEA agent Doug Herber wrote this editorial, which was published on May 31, 2019 in the White Mountain Independent. In it, he writes that drug importation will cause “patients [to] unwittingly purchase foreign counterfeit drugs disguised as low-level medication, unaware of the dangers, end up as an overdose statistic. “

Former State Pharmacy Board Presidents Warn That Drug Importation Won’t Keep Costs Down

May 30, 2019

This editorial by Holly Strom and Kenneth Schell published in U.S. News and World Report on May 28, 2019 warns states considering drug importation that doing so will not keep costs down and also poses a safety risk to patients…

Canadian Law Enforcement: our resources secure the Canadian drug supply, not foreign export shipments

May 23, 2019

In this editorial, which was published in The Bend Bulletin on May 21, 2019, Canadian law enforcement veteran Don Bell explains why Oregonians can not rely on Canada for safe prescription drugs.

Joni Inman of Front Range Pharmalogic Describes Canadian Drug Importation as a ‘Dangerous Myth’

May 22, 2019

Dozens of the most highly qualified law enforcement officials and former, senior staff at the U.S. Food & Drug Administration have conducted in-depth analyses that show Canadian drug importation will lead to a massive increase in counterfeit drugs entering the U.S.

ALEC’s Health and Human Services Task Force Director: “Don’t Import Prescription Drugs”

May 13, 2019

In this editorial published in The Hill on May 12, 2019, Brooklyn Roberts, the director of the health and human services task force at the American Legislative Exchange Council, discusses the risks of drug importation:

“The safety of our prescription drugs relies on a closed system where drugs can be traced to manufacturers, distributors, pharmacies and patients. Opening that system to foreign drugs would allow the potential for dangerous and potentially deadly medicines to land in the hands of the American public.”

Former FBI Director Warns About the Hidden Risks of Drug Importation

May 1, 2019

In this editorial published on April 30, 2019, former FBI Director Louis Freeh talks about the safety risks of drug importation: “There are hidden risks and costs associated with the scheme that have not been getting much attention which impact your health and Colorado law enforcement’s ability to keep us safe.”

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.”