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:

HHS's comment period for RIN 0910-AI45 ended on March 9th. Read PSM's summary of the results here.

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

Former Head of FDA-OCI: “Proposed drug importation law will worsen U.S. opioid epidemic”

July 11, 2017

The Philadelphia Inquirer published this editorial by George M. Karavetsos, a partner with the global law form DLA Piper, and former director of the U.S. Food and Drug Administration Office of Criminal Investigations.

Proposed Drug Importation Law Will Worsen U.S. Opioid Epidemic
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. Even librarians in drug-plagued neighborhoods . . .

Canadian Flag - Partnership for Safe Medicines

Executive Director of Cameron Institute “The Hidden Danger Of Loosening Regulations On Prescription Imports”

July 10, 2017

Investor’s Business Daily published this editorial by D. Wayne Taylor, Executive Director of the Cameron Institute, a not-for-profit, public policy think tank specializing in the independent study of health, social and economic issues both in Canada and around the world.

National Medical Association: “Minority Communities Need Better Health Care, Not Counterfeit Drugs”

June 26, 2017

On June 23, 2017, MorningConsult published this editorial by Garfield Clunie and Richard Williams. Clunie is the chairman of the board of the National Medical Association, a 501 (c) (3) nonprofit that represents African American physicians and their patients. Williams is the organization’s president.

State Boards of Pharmacy weigh in against importing drugs from Canada

June 21, 2017

Pharmacy boards, which ensure the safety of prescription medicines at the state level, have been sending letters to Congress to expressing significant safety concerns about legislation that would legalize drug importation.

First DHS Secretary: “It is too easy to ship deadly drugs in the mail”

June 21, 2017

The Salt Lake Tribune printed this editorial by Tom Ridge, the 43rd governor of Pennsylvania and first secretary of the U.S. Department of Homeland Security, on June 10, 2017. Ridge is currently a senior advisor to Americans for Securing All Packages (ASAP).

Health Policy Expert Declares Drug Importation “Unsafe, Unnecessary and Unwise”

June 9, 2017

This editorial was published by the Institute for Policy Innovation on June 5, 2017. Its author, Dr. Merrill Matthews, is a resident scholar with the Institute for Policy Innovation, a health policy expert and contributor at Forbes.com. He also serves on the Texas Advisory Committee of the U.S. Commission on Civil Rights.

A Patient Speaks Out: “Drug importation is dangerous.”

May 10, 2017

Ali Schroer wrote this editorial for the Washington Examiner on May 10, 2017.

Like millions of Americans, I take allergy medicine. A few years ago, my doctor urged me to bid farewell to my local pharmacy and instead buy my medication from an online Canadian drug store, where it was cheaper. What terrible advice! The website was counterfeit and sent me “medicine” that was anything but — causing me to get severely sick . . .

Hill Editorial Warns of Health Risks Resulting from Drug Importation Proposals

May 1, 2017

Ronald Piervincenzi, CEO of the U.S. Pharmacopeial Convention describes the dangerous flaws in any plan to open up U.S. borders to wholesale prescription medication importation from Canada.

Pew Trust Warns Senator Sanders that Drug Import Bill Could Compromise the Safety of the U.S. Drug Supply

March 14, 2017

On Tuesday, February 28, Allan Coukell, Senior Director of Health Programs for the Pew Charitable Trusts, wrote Senator Bernie Sanders to ask that he not undermine safety protections for medication with the Affordable and Safe Prescription Drug Importation Act.

The American Medical Association Opposes Drug Importation

December 13, 2016

In 2016, the American Medical Association reaffirmed its longheld  opposition to drug importation through two policy statements.  The first, “Prescription Drug Importation and Patient Safety D-100.983,” supports only the importation of FDA-approved medicines.  The second, “Federal Regulation and Computerized Tracking of Pharmaceuticals During Shipping and Handling from Manufacture Until Ultimately Received by Patient D-100.985,” promised to actively oppose drug diversion, illegal importation, and drug counterfeiting.