HHS's Federal Action Plan for Drug Importation, 2019
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.
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.
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:
- HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs
- Remarks on the Safe Importation of Certain Prescription Drugs
August 6, 2019:
- Letter from Chuck Grassley, the Chair of the Senate Committee on Finance, to HHS Secretary Alex Azar and Acting FDA Commissioner Ned Sharpless about the challenges of FDA ensuring the safety and efficacy of imported drugs.
August 20, 2019:
- Florida submits a Canadian Prescription Drug Importation Concept Paper to HHS
- Office of Information and Regulatory Affairs posts RIN 0910-AI45, a draft of the proposed rule for the importation of prescription drugs.
Pathway 2, Manufacturer Reimportation: Guidance for Industry
Pathway 3, Individual Waivers for Personal Importation: Request for Proposals
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.
- Learn about failures to save money and keep patients safe in previous importations programs in Maine, Illinois, and Minnesota.
- Every head of Health and Human Services and the FDA since 2003 has refused to certify the safety of drug importation
- Importation has been opposed by dozens of groups representing law enforcement, patients, regulators, and healthcare professionals for nearly two decades.
- Drug importation endangers U.S. patients by breaking our closed, secure drug supply
- Common misconceptions about drug importation
Challenges to importation:
- Canadian patient groups, healthcare groups, boards of pharmacy and the Canadian government have not agreed to importation.
- A 2018 study by PSM board member and pharmaco-economist Dr. Marv Shepherd shows that if 20% of U.S. prescriptions were filled using Canadian prescription drug sources, the Canadian drug supply would be exhausted in 183 days.
- Dr. Kristina Acri's analysis shows that importation programs are unlikely to save money because of the costs of testing medication and treating patients who encounter counterfeits.
- Importation breaks Track and Trace systems which have been in-process since 2013, when Congress passed the Drug Supply Chain Security Act.
- State Drug Importation Laws Undermine the Process That Keeps Our Supply Chain Safe (July 11, 2019)
- In February 2017, Alan Coukell, the senior director of health programs for the Pew Charitable Trusts wrote Senator Bernie Sanders, to raise concerns about the effect of importation on the pharmaceutical supply chain security provisions.
- To learn more about Track and Trace, consult the FDA and RXTrace
- Everything (or almost everything) you need to know about importing drugs from Canada, July 31, 2019
- Canada wasn’t consulted on specifics of U.S. plan to import prescription drugs, July 31, 2019
- U.S. demand is threatening Canada's drug supply, groups warn feds, July 26, 2019
- Exclusive: Canada warns U.S. against drug import plans, citing shortage concerns, July 18, 2019
- HHS Secretary Alex Azar dismisses drug importation as a gimmick, May 14, 2018
Op-eds from the Experts
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.
“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.”
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.”
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.
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.”
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.”
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.”
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.
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.”