Unbelievably, the FDA has increased seizures of international mail-order prescriptions over the past month.
Historically, far less than one percent of personal medicine imports are taken away by the FDA, despite the federal restrictions on importation. I only believe this to be the case if the exporting pharmacy requires a valid prescription. I don’t know if the FDA is more aggressive with rogue pharmacy actors than with legitimate pharmacies. I hope they are.
There are a few basic reasons why so many imports get through even when they may technically violate U.S. law:
First, enforcement discretion, through which the FDA can permit otherwise prohibited imports;
Second, political considerations, in that no administration wants to be viewed as taking away people’s medications, especially from older folks;
Third, the volume of imports being too great to handle with millions of packages coming in through international mail facilities;
and Fourth, in some instance the drug imports, as long as they are for personal use, could be deemed compliant with federal law.
If you’re interested, my most comprehensive treatment in this blog about how, despite federal restrictions on importation, the law protects personal drug importation is here.
This recent spike in seizures is happening during a time when almost the entire country is told to stay at home to protect others and themselves from contracting COVID-19. If a person’s medications do not arrive as ordered, then it’s more likely than ever that they will go without taking them. Why?
- While pharmacies are essential businesses and therefore are open, many people just will not leave their homes, believing the risk of contracting coronavirus worse than going without their medications.
- Tens of millions more people are unemployed and among them will be people who purchased a prescription drug from another country. Even before the pandemic, those people were not willing to pay or able to afford the U.S. price. Now, even more cannot afford the U.S. price.
- There are more drug shortages with potentially greater ones in the weeks and months to come, and the medications simply might not be available at their local pharmacy.
Moreover, if they can stay home, then they will not contract or spread the virus!
A worst-case scenario is that the FDA is using the crisis as an opportunity to crack down on personal drug importation. Could be. But there’s another explanation. Each year, there’s a global action called Operation Pangea, in which the FDA teams up with INTERPOL, as well as other drug regulatory agencies to clamp down on counterfeit drug sales with the focus on rogue online pharmacies. For the most part, during Operation Pangeas of years past, the FDA works to stop rogue websites from selling counterfeit drugs, prescription opioids shipped to people without a prescription, and other nefarious behavior. The initiative includes stepped-up Customs enforcement in which drug packages are taken at mail facilities.
But such operations can also lead to more legitimate prescription drugs and orders taken away from people who cannot afford the drug locally. This year, industry media reports that Operation Pangea is focused on clamping down on fake COVID-19 treatments and websites that offer them. No doubt there’s a need for greater regulatory scrutiny. At the same time, I believe that the FDA has the ability to tell when a prescription order coming in through an international mail facility is a lawfully made drug that does not represent an unreasonable risk.
Finally, as required by federal law, consumers will receive a letter from the FDA informing them that their drug has been detained before it’s officially taken away from them. That letter offers patients the chance to defend their import in writing (by email). At Prescription Justice, we have answers to your questions about these drug import detention letters and template language that people can use to draft responses to the FDA to try and get their medicines released. Just saying in the letter that the drug costs too much domestically can work, but often it won’t. We’re hoping that the coronavirus is a good reason for the FDA to release a detained personal drug import, especially where the patient has provided evidence of the safety of the imported drug and an accompanying prescription.
Miami Herald reporting ends on this very topic. Linda Gebhards is 69 years old and gets her estrogen drug, Premarin, internationally. It’s $97 outside the U.S. compared to $500 domestically. The FDA took it.
“‘It was really a shock when I got a seizure letter,’ Gebhards said. ‘I only had three pills left.’”