The suit came out of the blue, Franck says, adding that the deaths of the polo horses seemed to "ignite the whole complaint
from FDA and give them an ulterior reason to come in on us."
The complaint threatened the trust veterinarians placed in the pharmacy, and cost his company a "very substantial" amount
in legal fees, Franck says. It resulted in the layoff of 25 employees. Some were brought back gradually as business picked
up again, but many of his best employees had already moved away or found employment elsewhere.
Part of Franck's run-in with FDA stemmed from a series of conflicting policy revisions over the years—some of which were not
subject to public comment periods, he says.
In his Sept. 12 decision in favor of summary judgment for Franck's Pharmacy and denying FDA's motion for a permanent injunction,
U.S. District Judge Timothy J. Corrigan writes "FDA has long been on notice that its statutory authority to regulate traditional,
state-licensed veterinary pharmacy compounding was questionable ... It has decided to proceed with this enforcement action,
asserting a 'maximalist' interpretation of its authority."
FDA failed to back up other claims against Franck's, including allegations of compounding commercially available drugs or
compounding drugs in advance of a valid prescription, Corrigan wrote.
"Here, the FDA's authority to regulate pharmacy compounding as a disguise for manufacturing is not at issue. Rather, utilizing
this first-of-its-kind enforcement action, the FDA seeks to expand its statutory authority by enjoining an individual pharmacy
which is engaged in traditional pharmacy compounding of animal drugs in compliance with state law. In doing so, the FDA overreaches,"
Hundreds of pharmacies compound animal medications from bulk ingredients, governed by state regulations, without interference
from FDA, Corrigan adds.
"Allowing the FDA to enjoin a pharmacist's traditional, state-authorized practice of bulk compounding of animal drugs could
destabilize the pharmacy profession and leave many animal patients without the necessary medication," he writes. "Such a result
would be especially troublesome because the FDA's longstanding policy has been to permit, and even promote, pharmacists' compounding
from bulk ingredients. The FDA cannot simply upset the expectations it helped to create through decades of inaction without
explanation, especially where its asserted expansion of authority impacts the federal-state balance and potentially subjects
many individuals and companies to criminal liability."
FDA says it is reviewing the court's decision and has no official statement on the verdict.