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HHS's Federal Action Plan for Drug Importation, 2019

Synopsis:

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.

Current status:

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.

Planning documents

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

Photo of Salt Lake County Sheriff Rosie Rivera

Lowering prices “must not happen at the expense of public safety,” Utah sheriff says

December 3, 2019

This editorial by Rosie Rivera was published in The Salt Lake Tribune on December 3, 2019. Rivera is the sheriff of Salt Lake County.

photo of the author, C. Michael White

Pharmacy professor: buying prescription drugs from Canada “risky in terms of quality and safety”

September 27, 2019

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.

Cancer Center Pharmacist in Iowa Worries Drug Importation Will Harm His Patients

August 27, 2019

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.

Canadian Physician Warns that American Drug Importation is Bad for Canada

August 13, 2019

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.

Economist Warns that Federal Drug Importation is Folly

August 7, 2019

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.

Policy Expert: “Even if Canada were a willing participant, the U.S. can’t ensure the safety of these drugs.”

August 7, 2019

In this editorial, which was published in The Washington Examiner on August 5, 2019, Pacific Research Institute CEO Sally Pipes explains that ” importing prescription drugs would put our lives in danger.”

Importation Won’t Save Money, warn Citizens Against Government Waste

August 2, 2019

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.

Drug Distribution Experts Warn That State Plans To Import Foreign Drugs Will Undermine Safety

July 11, 2019

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…

Importation Is An Opportunity For Organized Crime to Expand Counterfeit Drug Profits, DEA Veteran Says

June 28, 2019

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.

Retired Canadian law enforcement official urges the New York Legislature: “Step Away” from dangerous drug importation proposal

June 20, 2019

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.”

PSM Coverage:

Between 2007 and 2018 Foreign Wholesalers Sold American Doctors Unreliable Black Market Cancer Drugs

August 9, 2018

Partnership for Safe Medicines Statement on FDA Working Group on Drug Importation

July 19, 2018

Drug Importation, Counterfeit Medications and the Pharmacist’s Liability: A Case Study and Legal Precedent

July 18, 2018

Mothers of Counterfeit Drug Victims Join Law Enforcement, Pharmacy Experts to Raise Alarm Over Lethal Fentanyl Imports

June 7, 2018

Partnership For Safe Medicines Urges Passage of the STOP Act to Increase Inspections for Dangerous Synthetic Opioids

May 24, 2018

Drugs From Online Canadian Pharmacies Come From A Lot Of Places, Just Not Canada

April 18, 2018

Senate HELP Asks Do We Want to Bypass the FDA Gold-Standard of Drug Approvals with Importation?

October 20, 2017

National Boards of Pharmacy Finds only 4.2% of Online Pharmacies Are Safe

August 25, 2017

Shepherd M (2018) U.S. Drug Importation: Impact on Canada’s Prescription Drug Supply. Health Econ Outcome Res Open Access 4: 146.

August 9, 2017

This Just In: Law Enforcement Groups Oppose Drug Importation Proposals

August 9, 2017

NADDI Warns Congress That Drug Importation Will Worsen the Opioid Crisis

August 1, 2017

National Sheriffs’ Association Opposes Legislation On Drug Importation

July 31, 2017

Kansas Woman Convicted of Tax Evasion Also Faces Counterfeit Drug Charges

July 28, 2017

Alliance for Safe Online Pharmacies Poll Finds Many Unaware of Dangers Posed by Fake Online Pharmacies

July 20, 2017

Former FBI Director Discusses the Dangers of Allowing Drug Importation in Radio Interview

July 17, 2017
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