HHS's Federal Action Plan for Drug Importation, 2019
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.
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.
Official actions and statements
July 31, 2019:
- HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs
- Remarks on the Safe Importation of Certain Prescription Drugs
August 6, 2019:
- Letter from Chuck Grassley, the Chair of the Senate Committee on Finance, to HHS Secretary Alex Azar and Acting FDA Commissioner Ned Sharpless about the challenges of FDA ensuring the safety and efficacy of imported drugs.
August 20, 2019:
- Florida submits a Canadian Prescription Drug Importation Concept Paper to HHS
- Office of Information and Regulatory Affairs posts RIN 0910-AI45, a draft of the proposed rule for the importation of prescription drugs.
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.
- Learn about failures to save money and keep patients safe in previous importations programs in Maine, Illinois, and Minnesota.
- Every head of Health and Human Services and the FDA since 2003 has refused to certify the safety of drug importation
- Importation has been opposed by dozens of groups representing law enforcement, patients, regulators, and healthcare professionals for nearly two decades.
- Drug importation endangers U.S. patients by breaking our closed, secure drug supply
- Common misconceptions about drug importation
Challenges to importation:
- Canadian patient groups, healthcare groups, boards of pharmacy and the Canadian government have not agreed to importation.
- A 2018 study by PSM board member and pharmaco-economist Dr. Marv Shepherd shows that if 20% of U.S. prescriptions were filled using Canadian prescription drug sources, the Canadian drug supply would be exhausted in 183 days.
- Dr. Kristina Acri's analysis shows that importation programs are unlikely to save money because of the costs of testing medication and treating patients who encounter counterfeits.
- Importation breaks Track and Trace systems which have been in-process since 2013, when Congress passed the Drug Supply Chain Security Act.
- State Drug Importation Laws Undermine the Process That Keeps Our Supply Chain Safe (July 11, 2019)
- In February 2017, Alan Coukell, the senior director of health programs for the Pew Charitable Trusts wrote Senator Bernie Sanders, to raise concerns about the effect of importation on the pharmaceutical supply chain security provisions.
- To learn more about Track and Trace, consult the FDA and RXTrace
- Everything (or almost everything) you need to know about importing drugs from Canada, July 31, 2019
- Canada wasn’t consulted on specifics of U.S. plan to import prescription drugs, July 31, 2019
- U.S. demand is threatening Canada's drug supply, groups warn feds, July 26, 2019
- Exclusive: Canada warns U.S. against drug import plans, citing shortage concerns, July 18, 2019
- HHS Secretary Alex Azar dismisses drug importation as a gimmick, May 14, 2018
Op-eds from the Experts
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.)
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.
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.”
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.”
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.
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 . . .
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.
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.
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.
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).