Louise’s Drug War

People who claim to know say don’t get sick in Europe because if you do, the medical care isn’t that great. Well, I wonder what they’re talking about when European drugs, which may be essential medicine, sometimes aren’t even allowed into America.

This all came to light when I had yet another run-in with bureaucracy. (I don’t deliberately seek out these arguments, honest.) This time I battled the U.S. Food and Drug Administration, which has so far been unable to absolutely identify the source of salmonella that has sickened more than 1,300 people but is ever vigilant in keeping my Swiss-made drugs from penetrating the embargo it has on overseas medicines.

The drama began because, for my high blood pressure, I take a Swiss drug called Lisitril, a generic pill made by Sandoz. I was summering on a lovely island in the northeast Atlantic, so I asked my chemist in Austria to send me a refill.

Not so fast! The FDA seized my FedEx shipment. According to a stern letter I received, “The following products are subject to refusal pursuant to the Federal Food, Drug and Cosmetic Act (FD&CA), Public Health Service Act (PHSA), or other related acts in that they appear to be adulterated, misbranded or otherwise in violation as indicated below.” It added that “FD&CA Section 505 (a), 801(a)(3); UNAPPROVED NEW DRUG…. Lisitril appears to be an unapproved foreign mfrd. version of the U.S. approved drug Lisinopril that is not in compliance w/ the PIP for a U.S. citizen.” Lisinopril just happens to be made by the Pittsburgh-based Mylan, among others.

The letter said that if I wanted to appeal the seizure, I should contact a compliance officer in Memphis, Tennessee. So I called her. Her explanation? “If you are an American, you must buy your medicine from an American pharmaceutical company, and if you have American medical insurance, you must buy American medicines.”

Of course I hit the ceiling because, first of all, I’m Austrian. (I didn’t tell her I was a countess, suspecting that might just antagonize her further.) I then informed her that, while I love America, I felt I was being discriminated against because my medicines weren’t stamped with tiny stars and stripes. In short, by confiscating my blood pressure medicine the FDA had sent my blood pressure sky-high.

I asked the compliance officer what would have happened if I had brought the Lisitril into the country in my handbag. She had no adequate response. Then I informed her that I had an Austrian passport. Shouldn’t that be enough to free my pills? “If you want us to release your medicine, send us a copy of your passport, and we’ll take up the case,” she said officiously.

And if I wanted to complain to someone else? “Well, you could consult the Freedom of Information Act,” she replied sharply. Though what FOIA has to do with my medicine I don’t know.

I was stumped. I reread the letter to see if there was any way out. All it did was make my head spin. “FDA will not request redelivery for examination or sampling, if the products not released by FDA are moved, following USCS conditional release to a location within the local metropolitan area or to a location approved by the FDA office at the number below.”

Huh? If that isn’t FDA gobbledygook, I don’t know what is. Why should an agency with primary responsibility for the nation’s foods and drugs be so obsessed with my little pills? I am aware that, earlier in the year, 19 U.S. deaths were linked to allegedly contaminated heparin from China. But my pills came from a respectable Swiss company that manufactures over 200 products in the U.S. and employs more than 1,500 Americans. And isn’t the FDA overwhelmed enough? According to a Government Accountability Office report this year, it has taken up to 27 years for the agency to inspect overseas companies that export “medium risk” devices like hearing aids to the U.S. and 13 years to visit some 3,200 foreign drug manufacturers. But it’s concerned about Lisitril!

I’ve written to my senator, my congressman, my member of Austrian parliament—even my doctor in Switzerland—to complain.

While I’m waiting for them to write back, I’ve returned to Europe. And now that I’m far away from the irksome FDA and amid the clear blue skies of the Alps, I can already feel my blood pressure dropping.