HHS's Federal Action Plan for Drug Importation, 2019

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].

Current status:

The regulations are schedule for an effective date of 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.

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:

August 6, 2019:

August 20, 2019:

Fall 2019:

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:

Challenges to importation:

Coverage:

 

Op-eds from the Experts

Former Florida AG: Importing prescription drugs could worsen opioid crisis

August 21, 2017

Bill McCollum, former attorney general of Florida and member of Congress, wrote about the dangers of drug importation on August 8, 2017:

“Opening the door to increased prescription drug importation will just make it easier for smugglers to ship this dangerous opioid into the United States. For years, we have asked police officers and prosecutors to do more with less. There are few signs that austerity will end. Changing laws to encourage importation of drugs would only add to that burden.”

Georgia Sheriff: Keep Dangerous Foreign Opioids Out Of Georgia

August 21, 2017

Terry W. Deese, Peach County, Georgia Sheriff and president of the Georgia Sheriffs’ Association, wrote this editorial for the Macon Telegraph. It was published on July 27, 2017.

“Georgia’s law-enforcement professionals and health officials are scurrying to stop the spread of these harmful pills. But in Washington, Congress may soon make it easier for counterfeit drugs like these — along with illicit prescription medicines — to enter the United States.

This effort doesn’t make any sense. Loosening restrictions on drug importation will worsen the opioid crisis.”

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.