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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

AIDS Drug Assistance Advocate: Drug importation policy is a hard pill to swallow

August 11, 2017

Brandon Macsata, the CEO of the AIDS Drug Assistance Program Advocacy Association, writes about the dangerous unreliability of imported medicines. (Originally published in the The Washington Blade and the ADAP blog.)

Former Attorneys General of Georgia and Florida Speak Out Against Drug Importation

July 24, 2017

The bills before Congress would remove many of the license and oversight requirements on the drugs imported into the United States by lifting those barriers, inviting an influx of bogus pharmaceutical products from the same crime rings that are selling these drugs in other countries around the world that would love better access to the U.S. market.

Law enforcement would inevitably be tasked with policing the problem, at a time when most prosecutors and law enforcement officials have their hands full with the growing opioid crisis. One of the biggest killers is fentanyl, a potent, synthetic opioid pain medication that is being laced into counterfeit pills.

Maryland Pharmacists Association Director: Importing Drugs May Endanger Patients

July 19, 2017

This editorial by Aliyah N. Horton, the executive director of the Maryland Pharmacists Association, was published in the Baltimore Sun on July 19, 2017.

In it, Horton points out the “huge public health risk” posed by buying imported drugs, and urges legislators to vote against unsafe drug importation, and to “seek other avenues to improve patient access, safety and drug affordability.”

Biotechnology Innovation Organization CEO Warns Against Drug Importation

July 14, 2017

In a July 14, 2017 editorial for STAT, Jim Greenwood, the president and CEO of the Biotechnology Innovation Organization (BIO), reminds us that the safety risks of buying prescription medicines from other countries are real:

“The debate about drug importation has been underway for decades. Those who support it have never advanced a responsible plan that would provide the same level of health and safety protections that the FDA has delivered for decades. Its rigorous system of rules and protocols ensure that prescription drugs in this country are safe and effective. It protects those high standards by preventing the sale of imported prescription drugs that are not approved for use in the U.S.”

Maine pharmacist: U.S. lawmakers should say no to drug import legislation

July 14, 2017

A few years ago, Maine introduced similar legislation that allowed patients to buy drugs from foreign pharmacies. We, too, wanted to provide patients with lower-cost medicines.

It proved to be a big mistake. Instead of getting drugs from Canada, we got dangerous and ineffective counterfeit pills from other countries. Maine’s disastrous experience with counterfeit Canadian drug imports should serve as a lesson to our lawmakers to say no to drug importation legislation.

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).

PSM Coverage:

PSM’s Executive Director Speaks on Morning Wakeup with Dave Akerly to Warn Michigan Residents about the Dangers of Drug Importation

December 5, 2019

Canadian Doctors, Pharmacists, Patient Groups and Government Representatives Consider State Importation Proposals Unfeasible

November 21, 2019

How do you test whether a medication is legitimate?

October 23, 2019

PSM, Partners Host Fall 2019 Congressional Briefings About Counterfeit Drug Dangers

October 3, 2019

Myth: We are getting the same drugs Canadians take

September 30, 2019

Shepherd M (2019) New pathways for U.S. importation threaten Canadian prescription drug supply. Canadian Health Policy Journal,

September 23, 2019

Drug Importation By the Numbers

August 28, 2019

PSM Statement on Florida’s Submission of Irresponsible Drug Importation Concept Document

August 25, 2019

Senator McSally Meets with Experts on the Counterfeit Drug Trade

August 14, 2019

Canadians Concerned About US Prescription Drug Importation Proposals

August 8, 2019

Prime Minister Trudeau Promises to Protect the Canadian Drug Supply In The Face Of The U.S. Drug Importation Statement

August 1, 2019

Partnership for Safe Medicines Statement on Reckless and Politically-Motivated Federal Drug Importation Proposal

July 31, 2019

ASOP Canada and 14 Other Canadian Patient Organizations Raise Alarm with Canadian Minister of Health on U.S. Drug Importation Proposals

July 30, 2019

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
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