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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

Texas Policy Analyst Questions Economic Impact and Safety of Drug Importation

September 22, 2017

Russell Withers, general counsel at the Texas Conservative Coalition Research Institute in Austin, believes that drug importation is “neither affordable nor safe.” In a September 20, 2017 editorial in the Austin-American Statesman , he argues that “it would hurt U.S. and Texas businesses, workers and patients’ and urges Texan congress members to oppose it.

Former FBI agent warns that drug importation risks “counterfeiting, fraud and powerful narcotics in the wrong hands”

September 22, 2017

Former FBI agent Eric O’Neill warned about the dangers of drug importation in Inside Sources on September 20, 2017. “The lull of normalcy,” he writes, “masks very real threats to a relatively well-functioning system, including counterfeiting, fraud and powerful narcotics in the wrong hands…while costs are important, we shouldn’t circumvent the safeguards that keep our medicines safe and reliable.”

US Will Be Exposed to Counterfeits From Weak European Drug Security Warns Expert

August 28, 2017

In early July, European authorities reported that counterfeit versions of Omnitrope, a drug containing human growth hormone, were found in France, Denmark, and Mexico. The counterfeit Omnitrope was designed to look like it was made by a large drug manufacturer, but it contained no active ingredient. Shortly thereafter, German authorities announced that a fake version of a schizophrenia drug, Xeplion, was discovered in Germany. The Xeplion was also a knock-off, mimicking packaging used in Bulgaria and Romania.

These incidents are the latest in a stream of reports about counterfeit drugs throughout Europe. The problem lies in lax security of the supply chain — distributors, middlemen and wholesalers between the drug maker and the consumer. Despite ongoing problems with the EU drug supply chain, Congress is currently considering a bill that would open the U.S. to imports from the EU and elsewhere. We can’t have a serious debate about drug importation without understanding what is going on in Europe.

DEA Agent Warns That a Single Fake Pill Containing Fentanyl Can Be a Death Sentence

August 25, 2017

Daniel R. Salter is a 30-year veteran of the U.S. Drug Enforcement Agency who has witnessed firsthand the devastation that fentanyl is causing to communities and the strain it is putting on law enforcement resources in Georgia…

Health Policy Expert: “Why Cheaper Drugs Can Kill”

August 24, 2017

Health policy expert Kenneth Thorpe weighs in on the dangers of drug importation in this August 23, 2017 editorial in U.S. News & World Report:

“…these savings could come at the cost of Americans’ lives. Legalizing drug importation would make it far easier for harmful counterfeit and contaminated medicines to enter the U.S. drug supply. At a time when illegal, counterfeit drugs already cause hundreds of American deaths every year, importation represents a reckless way to cut health care costs.”

Bioworld: Importation a cliché, not a CAPA

August 21, 2017

Mari Serebrov, the regulatory editor for biotechnology news site BioWorld, offered this opinion about drug importation on August 4, 2017.  

“On the surface, importing drugs from Canada seems like a no-brainer,” she writes, “especially when the Canadian version is virtually the same drug as the one approved by the FDA for the U.S. market – except a whole lot cheaper. But there’s the rub. How can Congress ensure that drugs imported from Canada are all that they claim to be?

While more than 40 countries have or are implementing security measures to protect their drug supply chain, Canada’s not one of them, Brian Daleiden, vice president of industry marketing at Tracelink Inc., told BioWorld. That puts importation – from Canada, at least – on a collision course with the U.S. Drug Supply Chain Security Act (DSCSA), which Congress passed in 2013 as part of the Drug Quality and Security Act.”

Physician: Sanders’ drug proposal comes with serious costs

August 21, 2017

The Daily Herald published this editorial by Dr. Terry Sellers about the shortcomings of drug importation as policy on July 25th, 2017. Sellers is a Utah-based physician specializing in addiction.

“… price is not the same as cost,” he writes, “In this case, cheaper prices will impose tremendous costs that would adversely affect the future of medicine for generations to come.” 

Former Director of the U.S. FDA’s Office of Criminal Investigations Warns Against Allowing Drug Importation

August 21, 2017

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, yet at the same time, some federal lawmakers have proposed legislation that would make it legal to import drugs that are not approved by the Food and Drug Administration into the United States from questionable sources. Such legislation would provide a gateway for international criminal organizations to import counterfeit prescription drugs and deadly illegal opioids, including fentanyl…

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.”

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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