Judge Rules Against FDA In Bid To Close Franck’s
Memories of the 2-year-old tragedy still echo through the U.S. veterinary, pharmacy and equestrian communities.
Memories of the 2-year-old tragedy still echo through the U.S. veterinary, pharmacy and equestrian communities. For Paul Franck, the details certainly remain fresh.
“I was taken aback initially,” Franck recalls of April 20, 2009, when he heard the news that 21 Venezuelan polo horses had died after receiving injections just before the U.S. Polo Championship in Wellington, Florida. “I was hoping it wasn’t our pharmacy, that we weren’t involved with the prescription.”
Franck added that his compounding lab is “at a good point now.” Which means circumstances have changed quite a bit from those of April 2009.
A high-profile tragedy such as the polo horse deaths is a nightmare for any organization that fills prescriptions. But a company such as Franck’s has to be ready to deal with misfills, Franck said, because no matter how diligent your operation, they are going to happen.
“In our industry, there are misfills on a weekly basis,” he said. “It’s how you divulge them—how you move forward and deal with the situation—that matters.”
After the horses died, Franck’s immediately hired an outside source to investige. Results revealed that the prescription was incorrectly filled as a result of a mathematical error in converting the concentration of sodium selenite requested by the veterinarian. As done in South America, the prescription listed ingredients “as per 100ml,” instead of “as per ml,” as done in the U.S. Franck said the pharmacist verified the prescription with the veterinarian’s office twice before compounding the preparation, but the veterinarian did not detect the error. The pharmacist, therefore, unknowingly directed that the solution be compounded with an incorrect—and lethal—dose of sodium selenite.
“This was the first time Franck’s had ever filled that formulation,” Franck said. “Our pharmacist should have looked up the proper dosage of the selenium and then discussed with the veterinarian. But when we called to verify the dose and the prescribing veterinarian said it was correct, we assumed the prescription was being properly filled.”
Reprimand and Fine
After an investigation by the Florida Board of Pharmacy, Franck’s received the letter of reprimand and administrative fine. The pharmacy has regained its good standing with the board, but that didn’t prevent litigation by the FDA, which contended that a veterinary medication compounded from bulk ingredients constitutes a new, unapproved drug.
“Because this incident received so much media coverage, Franck’s became a lightning rod for the FDA,” says Franck. “We were an easy target.”
According to Franck, compounding animal and human medications from bulk substances has become more common among compounders over the past 20 years because of concerns about the quality, safety and efficacy of medications compounded from finished products.
“It is important to recognize, as the FDA’s complaint makes clear, the government has not made any allegations against Franck’s compounding of human drugs, and raised no issue as to the quality of Franck’s compounding practices,” Franck added.
In May 2010, Franck’s voluntarily suspended its veterinary compounding practice to confer with the FDA to determine whether its concerns could be addressed without further litigation. Franck’s and the FDA were unable to reach a resolution, so in July 2010, Franck’s moved to dismiss the FDA complaint.
“Despite our willingness to continue the voluntary suspension until a hearing on the merits, the FDA asked the district court in Florida to immediately enjoin us from compounding animal drug products,” says Franck.
“The FDA made this request through a motion for a preliminary injunction,” Franck continues. “In its motion, the FDA set forth the same legal theory as in its complaint for permanent injunction—that animal medication compounded from bulk ingredients constitutes a new unapproved drug, rendering them unsafe and ineffective under the Federal Food, Drug and Cosmetic Act.”
In response, Franck’s argued that the new drug requirements under the FDCA do not extend to traditional pharmacy compounding practices, which include compounding animal medications from bulk substances. The pharmacy also argued that state pharmacy compounding laws in the U.S. authorize compounding of animal medications from bulk drug substances.
“The injunction against the pharmacy conflicts with Florida state law, which permits the compounding of both human and animal medications from bulk substances,” says Franck. “According to the FDA, we can’t compound from bulk chemicals for veterinary use because they are unsafe, yet they say it’s OK to compound from bulk for humans. This doesn’t make sense.”
In August 2010, a Florida court heard arguments and ultimately denied the FDA’s motion for preliminary injunction.
“In rendering its decision, the court made clear that the FDA had not proven substantial likelihood of success with this lawsuit, based on the merits of its legal theory,” says Franck.
The FDA’s complaint was not dismissed entirely until Judge Corrigan’s ruling in September, but Franck’s had notified the FDA that it was resuming compounding animal medications after the August 2010 decision.
“Fortunately, although this incident has impacted Franck’s considerably, it has not had a major impact on the veterinary compounding industry,” said Franck. “It is still a very safe industry. There are more misfills in regular prescription dispensing than in compounding.”
Franck added that some veterinarians are concerned about the safety of compounding because of erroneous notions that the practice is unsafe.
“We test our formulas for quality and sterility, and can back this up,” said Franck. “Veterinarians around the country use compounded formulas, and these preparations save lives.”
As for the process of fighting the court challenge, Franck said the opportunities for lessons rest with the FDA. The FDA had not decided at press time whether to appeal.
“We feel that it would be a better process if the FDA would go after the compounders that are truly disguising their efforts instead of the ethical pharmacies that are trying to do it right.”
Dennis Arp contributed to this report.