HHS's Federal Action Plan for Drug Importation, 2019
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.
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.
Official actions and statements
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.
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
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.”
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.
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.”
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.
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.
In this October 16, 2018 for Drug Topics, Alliance of Safe Online Pharmacies advisor Libby Baney and pharmacist and American Pharmacists Association CEO Thomas Menighan discuss the risks to public safety posed by drug importation.
There are certainly things we can learn from other countries’ healthcare successes, but importation is not the right approach.
This distressing situation shows that deadly fentanyl analogues are killing Americans who are using laced non-opioid prescriptions.