Here is the story of Nero, a cane corso (Italian mastiff), whose owner, Patrick Bianco, later told me that this breed was famous in history as the war dogs of the Roman Empire, the guardians of Caesar! (Indeed, as I noted with obvious irony, but to no response, they didn't do that great a job.)
Anyway, Nero was bought from a breeder in Sicily and carried a hitchhiker on his voyage to the States – a Leishmania parasite spread by sand flies common to the Mediterranean.
Not long after, the dog became sick, but through the efforts of international doctors at a New York veterinary center who had the right drugs, Nero survived and prospered. In mid-April, he showed symptoms of the disease again, and Bianco arranged to have the international pharmaceutical company Merial prescribe and ship the needed drug, Glucantime, to him. But Nero got sicker and sicker, bleeding profusely from the nose, while waiting for the shipment. It arrived April 11, but it had to clear the necessary customs and FDA screening process at John F. Kennedy International Airport before the shipping company (DHL) could release it.
There it sat while a compassionate but clear-headed receptionist at Franklin Lakes Animal Hospital, doggedly pursued getting the Glucantime to Nero. Because the drug is not approved for use in the United States – leishmaniasis is barely present in America and no drug company has applied for FDA approval – it was routinely held in “detention” by customs and FDA officials until explanations could be made.
It was not made clear that this was an emergency case until receptionist Donna Pontrelli called a New York area television station. When that reporter contacted FDA at 4:55 p.m Friday evening, April 16, the agency swung into action. The case moved swiftly from the Office of Public Affairs, to the Center for Veterinary Medicine, to the Office of Regulatory Affairs to the Emergency Operations staff and then to (Mr.) Camille Mondé, FDA’s Director of Import Operations for New York City.
He came back to the office from home, got on the phone to DHL, which was closing its JFK desk for the day, ordered the drug released, and began cell phoning and texting with Pontrelli, who was waiting for the word. It came by 7 p.m. She drove two hours through the rain to pick up the Glucantime from a DHL executive who was standing by, and then drove it back to Franklin Lakes, where Nero was treated the next morning by veterinarian Jill Shiffman and began to improve almost immediately.
Although FDA must by law screen for and detain unapproved drugs to prevent adulterated medications for both humans and animals from entering the country, the agency may use enforcement discretion in emergency cases for the personal use of a product that is not available domestically. Such was the case with Nero’s Glucantime.
“We’re very pleased with the way it worked out in the end,” a grateful Bianco said.
Said an ebullient Pontrelli: “I love the FDA. We wouldn’t be where we are today without you."
FDA? Yes, where I work ... the Food and Dog Administration, at least for one night.