November 16, 2011
DOJ challenges ruling in veterinary compounding case
Appeal sought of decision that restricted FDA's authority
By: Jennifer Fiala
For The VIN News Service
The U.S. Department of Justice (DOJ) wants a federal appeals court to overturn a Florida judge’s ruling that rejected food and drug regulators’ jurisdictional power over compounded medications.
Lawyers with the department filed a notice of appeal on Thursday in U.S. District Court for the Middle District of Florida, where Judge Timothy Corrigan recently chastised the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) for overstepping its jurisdictional boundaries when it tried to end the veterinary side of Franck's Pharmacy's compounding business.
Compounding is the centuries-old practice of mixing bulk chemicals to make tailored medications for individual use. Many veterinarians routinely rely on compounding when they need a medication custom-formulated for animals.
State pharmacy laws and regulations govern compounding operations, however the FDA has argued that compounding pharmacies are “manufacturing” drugs and therefore should be subject to regulatory oversight by the agency.
In his Sept. 12 decision, Corrigan took the FDA to task for acting with enforcement authority that the agency was not authorized by Congress to possess. To expand its oversight, the FDA must go through federal rules-making processes to map new regulations, he stated. The judge also ruled that the size and scope of a compounding pharmacy's business does not indicate whether it's operating as a manufacturer.
The justice department wants the U.S. Court of Appeals for the 11th Circuit, which has jurisdiction over federal cases originating in Alabama, Florida and Georgia, to quash Corrigan’s ruling. However, arguments in the government’s appeal are not yet clear. It’s too early to talk specifics, said Charles Miller, a spokesman in the justice department’s civil division.
"There is no brief yet,” Miller stated in an email to the VIN News Service. “The schedule for briefing hasn’t even been set.”
Mark Brown, a Washington, D.C.-based attorney who represented Franck's in the lower court, could not be reached.
Franck’s made international headlines in April 2009, when the pharmacy admitted to improperly mixing a vitamin and mineral supplement that caused the deaths of 21 polo horses at the U.S. Open Polo Championships match. The Florida Board of Pharmacy fined Franck’s but allowed the pharmacy to continue operating without restriction. The FDA got involved as well, making the first of three inspections of the pharmacy days after the incident.
In April 2010, the FDA sought a permanent injunction to close the veterinary side of Franck’s, which also compounds medications for humane medicine. The agency's bid was turned down by the U.S. District Court for the Middle District of Florida.
That rejection led to hearings on the case in which the FDA alleged that Franck’s sold adulterated and misbranded drugs in violating federal food and drug laws. What’s more, the agency claimed, Franck’s illegally sold mimics of commercially available pharmaceuticals.
Courtroom statements made by attorneys for the FDA that implicate all of veterinary compounding have attracted the most attention. During oral arguments in February, the FDA made two clear assertions:
• All veterinary preparations compounded from bulk ingredients and sold over state lines are “new animal drugs” and subject to the FDA’s full regulatory oversight under the Federal Food Drug and Cosmetic Act (FDCA). The agency made no differentiation between single compounded preparations and those mass produced.
• Any preparation compounded using bulk API (active pharmaceutical ingredients) is a new drug, per the FDCA. If the compounded preparation is not submitted for review, it is not only unapproved, it is illegal.
Though the FDA lost in district court, an appeals court ruling in the agency's favor could dramatically alter the way veterinary compounding pharmacies operate. One scenario: Compounding pharmacies could be forced to work with finished medications rather than bulk chemicals, which would make creating tailored drugs nearly impossible in some cases.
The International Academy of Compounding Pharmacists (IACP) is among those monitoring the appeal and believes that the precedent-setting case could have national ramifications. In a statement, IACP President John Herr, R.Ph., FIACP, chided the FDA for challenging the district court's ruling on the matter.
"Despite Judge Corrigan's clear ruling that the FDA once again attempted to exceed its jurisdictional authority, the agency seems determined to waste taxpayers' money with another lengthy and unnecessary legal case," Herr said.
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