HHS's Federal Action Plan for Drug Importation
On May 24, 2022, PSM held an online congressional briefing with a panel of experts to let legislators know why drug importation is a dangerous proposition. Watch briefing highlights or the entire event.
Current status:
The regulations took effect on November 30, 2020. PSM, PhRMA, and CAHC have filed suit in federal court to block them from taking effect.
On May 28, 2021 the Department of Health and Human Services filed a motion to dismiss the suit on the grounds that PSM, PhRMA, and CAHC did not have grounds to sue until the government had approved a state importation program.
PSM, PhRMA, and CAHC filed an amended complaint on July 2, 2021.
In the meantime, Colorado and Florida have submitted applications to begin state importation programs.
The State of Florida and Florida's Agency for Health Care Administration filed suit against the FDA and Department of Health and Human Services for delaying approval of its state importation program in August 2022.
Synopsis:
On September 24, 2020, the federal government released a Final Rule on Canadian drug importation (pathway 1), as well as Industry Guidance for 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].
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 haven't implemented their 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 Since the Rule was Approved
June 1, 2021: Florida files an amicus brief in support of HHS's importation rule.
May 28, 2021: HHS files a motion to dismiss the suit.
November 23, 2020: PSM, Pharmaceutical Research and Manufacturers of American and The Council for Affordable Healthcare file a complaint alleging that the Final Rule disregards key protections of the Federal Food, Drug, and Cosmetic Act
Timeline of the approval of final rule for Canadian drug importation
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:
August 20, 2019:
- Florida submits a Canadian Prescription Drug Importation Concept Paper to HHS
Fall 2019:
- Office of Information and Regulatory Affairs posts RIN 0910-AI45, a draft of the proposed rule for the importation of prescription drugs.
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
Letter from HHS Secretary Alex Azar to House Minority Leader Kevin McCarthy certifying the final rule on wholesale Canadian drug importation, September 23, 2020.
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:
- 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
Coverage:
- 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
As PSM’s Board President, Dr. Marv Shepherd, wrote in an editorial for the Washington Examiner that was published on October 10, 2017, opening the United States to unregulated, imported drugs will offer fentanyl traffickers even more access to Americans:
“The reality is that criminals throughout the illegal supply chain from China to the streets of U.S. cities are making money at the cost of American lives. We need to be taking steps to eliminate illegal fentanyl from our communities, not providing new avenues for those who want to see just the opposite happen.”
Paul Honeman is a former Anchorage Assemblyman representing East Anchorage. He also is a retired Anchorage Police Department Lieutenant. In this September 28, 2017 editorial in The Bristol Bay Times, he highlights the dangers posed by drug importation and reminds everyone why it is currently banned…
CNN’s September 25, 2017 Healthcare Town Hall was an opportunity for prominent senators to share important ideas about ways to improve Americans’ lives, but it also included some erroneous statements about drug importation. PSM’s Board President, Dr. Marv Shepherd, sent this letter on September 29 to clarify those issues.
The Nevada Sheriffs’ and Chiefs’ Association sent a letter to Senator Heller explaining their reasons for opposing S. 469, the bill that would allow drug importation…
Russell Withers, general counsel at the Texas Conservative Coalition Research Institute in Austin, believes that drug importation is “neither affordable nor safe.” In a September 20, 2017 editorial in the Austin-American Statesman , he argues that “it would hurt U.S. and Texas businesses, workers and patients’ and urges Texan congress members to oppose it.
In early July, European authorities reported that counterfeit versions of Omnitrope, a drug containing human growth hormone, were found in France, Denmark, and Mexico. The counterfeit Omnitrope was designed to look like it was made by a large drug manufacturer, but it contained no active ingredient. Shortly thereafter, German authorities announced that a fake version of a schizophrenia drug, Xeplion, was discovered in Germany. The Xeplion was also a knock-off, mimicking packaging used in Bulgaria and Romania.
These incidents are the latest in a stream of reports about counterfeit drugs throughout Europe. The problem lies in lax security of the supply chain — distributors, middlemen and wholesalers between the drug maker and the consumer. Despite ongoing problems with the EU drug supply chain, Congress is currently considering a bill that would open the U.S. to imports from the EU and elsewhere. We can’t have a serious debate about drug importation without understanding what is going on in Europe.
Health policy expert Kenneth Thorpe weighs in on the dangers of drug importation in this August 23, 2017 editorial in U.S. News & World Report:
“…these savings could come at the cost of Americans’ lives. Legalizing drug importation would make it far easier for harmful counterfeit and contaminated medicines to enter the U.S. drug supply. At a time when illegal, counterfeit drugs already cause hundreds of American deaths every year, importation represents a reckless way to cut health care costs.”
Mari Serebrov, the regulatory editor for biotechnology news site BioWorld, offered this opinion about drug importation on August 4, 2017.
“On the surface, importing drugs from Canada seems like a no-brainer,” she writes, “especially when the Canadian version is virtually the same drug as the one approved by the FDA for the U.S. market – except a whole lot cheaper. But there’s the rub. How can Congress ensure that drugs imported from Canada are all that they claim to be?
While more than 40 countries have or are implementing security measures to protect their drug supply chain, Canada’s not one of them, Brian Daleiden, vice president of industry marketing at Tracelink Inc., told BioWorld. That puts importation – from Canada, at least – on a collision course with the U.S. Drug Supply Chain Security Act (DSCSA), which Congress passed in 2013 as part of the Drug Quality and Security Act.”
The Daily Herald published this editorial by Dr. Terry Sellers about the shortcomings of drug importation as policy on July 25th, 2017. Sellers is a Utah-based physician specializing in addiction.
“… price is not the same as cost,” he writes, “In this case, cheaper prices will impose tremendous costs that would adversely affect the future of medicine for generations to come.”
More than 60,000 Americans died from drug overdoses last year. Fentanyl, a synthetic opioid 100 times more powerful than morphine, caused one-fifth of those fatalities. Local law enforcement and health professionals are working at a feverish pace to prevent fatal overdoses, yet at the same time, some federal lawmakers have proposed legislation that would make it legal to import drugs that are not approved by the Food and Drug Administration into the United States from questionable sources. Such legislation would provide a gateway for international criminal organizations to import counterfeit prescription drugs and deadly illegal opioids, including fentanyl…