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HHS's Federal Action Plan for Drug Importation, 2019

Synopsis:

On December 18, 2019, the U.S. Department of Health and Human Services (HHS) released proposed regulations for importation by pharmacists and wholesalers (Pathway #1) or by manufacturers (Pathway #2).

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

Canadian health law experts predict: Canada won’t end up as the drugstore to the U.S.

January 16, 2020

This editorial by David C. Rosenbaum and Dara Jospé was published in the Financial Post on January 16, 2020. Rosenbaum is a partner of the law firm Fasken. Jospé is an associate for the same company.

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.

PSM's Statement on Proposed Regulations to Import Prescription Medicines from Canada

"Citizens of the United States and Canada should be outraged that the Trump Administration has prioritized politics over their own health and safety..."

Read more, and track policymaker response to HHS's proposal.


PSM Coverage:

Things we learned from sending a Freedom of Information Act request to Florida’s healthcare agency implementing importation

July 24, 2019

Medical Device King Exec Takes a Plea Deal Instead of a Retrial; Gets 32 Months in Prison

July 17, 2019

New Analysis by HDA Finds Importation Proposals Are Too Expensive and Pose Health Risks to Patients

July 16, 2019

National Pharmacy Organizations Ask HHS Secretary Azar for Clarity on Drug Importation Proposals

June 28, 2019

New PSM ad reminds us that politics should never take precedence over safety when it comes to medicine.

June 12, 2019

PSM responds to AMA resolution #129 (A-19) on Mexico drug importation – June 9, 2019

June 10, 2019

Florida Agency for Health Care Administration releases Request for Information for Canadian Prescription Drug Importation Program

May 29, 2019

Husband of Former Pennsylvania Township Commissioner Charged in Fake Online Pharmacy Case

May 20, 2019

Former FDA Commissioner Scott Gottlieb condemns importation proposals and points out Florida’s sordid history with wholesale counterfeit drugs

May 10, 2019

Partnership for Safe Medicines’ Statement in Response to President Trump’s Comments on Foreign Drug Importation

May 10, 2019

New Mexico Pharmacists Association Expresses Concern Over Allowing Drug Importation In Letter to Congress

April 30, 2019

Politifact ignores the world of criminal counterfeiters

April 25, 2019

New PSM ads highlight concerns of FDA Commissioner Gottlieb about the dangers of Florida’s importation legislation

April 19, 2019

North Carolina Man Who Imported Counterfeit Xanax from Canada Sentenced to 2 Extra Days in Prison in Sled Border-Crossing Case

April 10, 2019

PRESS RELEASE: Over 100 Organizations Representing Law Enforcement Officers, Healthcare Professionals, Patient Advocates Urge White House and Congress to Reject Prescription Drug Importation

April 9, 2019
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