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
This editorial by Rosie Rivera was published in The Salt Lake Tribune on December 3, 2019. Rivera is the sheriff of Salt Lake County.
This editorial by C. Michael White was published in The Conversation on September 27, 2019. White is a professor and head of the Department of Pharmacy Practice for the University of Connecticut.
This editorial by Dana McDougall was published in The Waterloo Cedar Falls Courier on August 26, 2019. Mr. McDougall, Pharm.D., BCPS, is a pharmacist with the Covenant Cancer Treatment Center in Waterloo, Iowa.
This editorial by Dr. Charles S. Shaver was published in The Hamilton Spectator on August 11, 2019. Dr. Shaver i a practicing physician in Ottawa. He is a graduate of Princeton University and Johns Hopkins School of Medicine. Dr. Shaver is also past chair of the section on general internal medicine of the Ontario Medical Association.
This editorial by Wayne Winegarden, Ph.D. appeared in Forbes on August 7, 2019. Dr. Winegarden is the Managing Editor for EconoSTATS and a senior Fellow in Business and Economics at the Pacific Research Institute.
In this July 31, 2019 blog post on the Citizens Against Government Waste (CAGW) website, CAGW Director of Health and Science Policy Elizabeth Wright questions the questions the effectiveness and safety of government importation schemes.
This editorial by Adam Fein and Dirk Rodgers was published in Stat News on July 11, 2019. In it, Fein and Rodgers warn that plans by states to create drug importation programs will open new pathways for counterfeit drugs to enter the U.S. drug supply chain…
This editorial by retired DEA agent Douglas Hebert was published in The Arizona Capital Times ,on June 27, 2019. In it, Hebert explains how drug importation programs will help organized crime expand their $200 billion-a-year counterfeit pharmaceutical industry into the U.S., at the expense of Americans.
In this editorial, which was published in Crain’s New York Business on June 19, 2019, Canadian law enforcement veteran Don Bell explains that the New York Legislature’s effort to establish a wholesale prescription drug importation program, is “a gigantic loophole that criminals will pounce on to traffic counterfeit drugs into the state.”