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

Drug Importation threatens people with chronic illnesses, says advocate.

June 12, 2019

This editorial by Guy Anthony was published in the Orlando Sentinel on June 12, 2019. Anthony, President and CEO of Black, Gifted & Whole, a nonprofit focused on issues surrounding black, queer men, warns that drug importation will open up “a market for dangerous, counterfeit drugs” that will make it harder for people to live with HIV and other complex illnesses.

Canadian Policy Researcher Warns That Importation Plans By U.S. States Would Leave Canada Without Crucial Medicines

June 11, 2019

This editorial by Nigel Rawson was published in The Hills Times on June 9, 2019. Dr. Rawson, president of Eastlake Research Group, a senior fellow at the Fraser Institute, and an affiliated scholar with the Canadian Health Policy Institute, warns that Canada would run out of necessary medicine if U.S. states begin drug importation programs…

Former DEA Agent on how drug importation will exacerbate the opioid crisis

May 31, 2019

Former DEA agent Doug Herber wrote this editorial, which was published on May 31, 2019 in the White Mountain Independent. In it, he writes that drug importation will cause “patients [to] unwittingly purchase foreign counterfeit drugs disguised as low-level medication, unaware of the dangers, end up as an overdose statistic. “

Former State Pharmacy Board Presidents Warn That Drug Importation Won’t Keep Costs Down

May 30, 2019

This editorial by Holly Strom and Kenneth Schell published in U.S. News and World Report on May 28, 2019 warns states considering drug importation that doing so will not keep costs down and also poses a safety risk to patients…

Canadian Law Enforcement: our resources secure the Canadian drug supply, not foreign export shipments

May 23, 2019

In this editorial, which was published in The Bend Bulletin on May 21, 2019, Canadian law enforcement veteran Don Bell explains why Oregonians can not rely on Canada for safe prescription drugs.

Joni Inman of Front Range Pharmalogic Describes Canadian Drug Importation as a ‘Dangerous Myth’

May 22, 2019

Dozens of the most highly qualified law enforcement officials and former, senior staff at the U.S. Food & Drug Administration have conducted in-depth analyses that show Canadian drug importation will lead to a massive increase in counterfeit drugs entering the U.S.

ALEC’s Health and Human Services Task Force Director: “Don’t Import Prescription Drugs”

May 13, 2019

In this editorial published in The Hill on May 12, 2019, Brooklyn Roberts, the director of the health and human services task force at the American Legislative Exchange Council, discusses the risks of drug importation:

“The safety of our prescription drugs relies on a closed system where drugs can be traced to manufacturers, distributors, pharmacies and patients. Opening that system to foreign drugs would allow the potential for dangerous and potentially deadly medicines to land in the hands of the American public.”

Former FBI Director Warns About the Hidden Risks of Drug Importation

May 1, 2019

In this editorial published on April 30, 2019, former FBI Director Louis Freeh talks about the safety risks of drug importation: “There are hidden risks and costs associated with the scheme that have not been getting much attention which impact your health and Colorado law enforcement’s ability to keep us safe.”

Economist questions the fundamentals of importation: “It flunks a basic policy analysis.”

April 29, 2019

In this editorial published on April 26, 2019, Douglas Holtz-Eakin, economist and President of American Action Forum, questions economic truths about drug importation:

“Drug reimportation has long been the fool’s gold of health policy, and the Florida bill is no different. It flunks a basic policy analysis. But most amazing, it is drafted to raise hope, but not actually help Floridians.”

Journalist on drug importation: “There is a real risk.”

April 28, 2019

In this piece published in the Washington Free Beacon on April 25, 2019, staff writer Charles Fain Lehman explores issues around Florida’s drug importation proposal. “Critics,” he notes, “fear that the actual realities of regulatory oversight—especially in the hand of an as-yet-unnamed private vendor—will simply be too challenging to manage responsibly.”

PSM Coverage:

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

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