Op-eds: Canadian and American regulators, law enforcement and patient advocates oppose drug importation

Since 2000, every head of the United States Food and Drug Administration (FDA) and United States Department of Health and Human Services (HHS) has opposed drug importation because the benefits that might be gained are far outweighed by the many dangers. Law enforcement, patient advocates, pharmacy groups, and regulators agree.

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

Aug 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

Aug 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…

JAMA editorial supports declaring the opioid epidemic a national emergency

Aug 25, 2017

An August 23, 2017 editorial in the Journal of American of the American Medical Association (JAMA) supports President Trump’s stated intention to declare the nation’s opioid epidemic a national emergency.

Health Policy Expert: “Why Cheaper Drugs Can Kill”

Aug 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

Aug 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

Aug 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

Aug 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

Aug 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

Aug 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

Aug 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.)