Franck’s Pharmacy negotiates with FDA in Washington on veterinary compounding
Pharmacy and a group of high profile stakeholders in veterinary compounding
reportedly are in talks with the U.S. Food and Drug Administration (FDA) today
On the table: the legality of veterinary compounding and the agency’s attempt
to shut down Florida-based Franck’s by banning the company and CEO Paul Franck
from compounding animal drugs from bulk ingredients.
News of the meeting in Washington reached the VIN News Service on Tuesday,
when Franck’s Jerry Smith, chief financial officer, reported that the two sides
planned to gather near the agency’s headquarters, along with the “elite of the
veterinary industry” in terms of compounding.
When asked for specifics concerning today’s meeting and details on what
prompted the company to stop producing drugs for animals after initially
defending its right to do so, Franck’s Smith responded: “We don’t want to do
anything to annoy our adversaries. This could be the damnation of all of
Officials with the FDA’s Center for Veterinary Medicine could not
immediately be reached.
Status Report filed on Tuesday with the U.S. District Court in the Ocala
Division of the Middle District of Florida reveals that Franck’s stopped
compounding veterinary drugs as of midnight, May 14. The report states that,
“During the pendency of this voluntary suspension, the parties agree to pursue
good faith negotiations for a mutually agreeable solution to this matter.”
The FDA is permitted to make unannounced visits to Franck’s
13,000-square-foot facility in Ocala, Fla., to assure that the company is in
compliance with the filing.
Franck’s issued a statement in keeping with the arrangement on May 17,
reporting that the company voluntarily put its veterinary compounding business
on hold while it awaits the outcome of its “discussions” with the FDA.
Those talks likely will center the FDA’s recent petition of the U.S.
district court, requesting a permanent injunction
against Franck’s amid allegations that the company violates federal law by
selling adulterated and misbranded drugs. The agency also accuses Franck’s,
among other things, of illegally selling mimics of available pharmaceuticals
and alleges that some of its compounding practices carry significant health
risks. The action comes roughly a year after 21 horses died before a
championship polo match in West Palm Beach, Fla. It was later determined that
the horses overdosed on selenium, part of a cocktail of vitamins and minerals
produced by Franck's. The company accepted responsibility, admitting that the
formula was incorrectly prepared.
Immediately following the FDA’s petition, Franck’s publicly promised to
defend its role as a compounder of prescription veterinary medications and
asserted that the company is in compliance with federal laws as are its quality
When asked if Franck’s made a deal with federal regulators to mitigate fines
and penalties, a company representative rejected the notion.
Officials at Franck's declined to give further details on what prompted the
decision to end veterinary compounding or clarify when or if the company will
address specific allegations in the FDA petition. A response is due in court by
The April 16 filing of the injunction — an unprecedented action on the part
of the FDA — has been viewed by some to signify efforts by the agency to reign
in what critics believe to be an overly liberal use of compounding in
veterinary medicine. The stakes appear high, with compounding playing a growing
role in how veterinarians obtain drugs for animals, especially exotic species.
The complexities of veterinary compounding have long been up for debate
among its stakeholders — regulators, compounding pharmacies, pharmaceutical
manufacturers, veterinarians and end users. Compounding is intended to be used
to prepare medications for individual patients whose needs cannot be met by
FDA-approved drugs already on the market. Compounded drugs aren’t subject to
the rigorous and expensive FDA approval process to test for safety and
Additionally, the Animal Medicinal Drug Use Clarification Act of 1994
(AMDUCA) prohibits compounders from using bulk ingredients as their base
materials rather than starting with FDA approved drugs, yet compounders say
they cannot produce medications otherwise. (The VIN News Service explored
veterinary compounding in depth for a two-part series.)
In a recent interview with the VIN News Service, Gigi Davison, director of
clinical pharmacy services at North Carolina State University’s College of
Veterinary Medicine, stated, “FDA seems to be using Franck’s to make a
generalized, broad sweeping of veterinary compounding.”
Davidson, a well-known authority on veterinary compounding, is in on
Franck’s negotiations with the FDA in Washington, according to Smith, the
company's CFO, though she could not be reached for comment.
Dr. Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine,
acknowledged the important role that compounding plays in veterinary medicine
in a statement, released last month following news of the petition for an
"FDA recognizes the benefit of the traditional practice of pharmacy
compounding — providing a service in response to a valid prescription to
accommodate the specialized needs of a particular patient," Dunham says in
the statement. "But when compounders like Franck's circumvent, and thus
undermine, the statutory drug approval process by manufacturing drugs under the
guise of pharmacy compounding, we are concerned that poorly compounded drugs
can jeopardize the health of animals."
Meanwhile, the decision to stop compounding animal drugs will affect a
"small" portion of the Franck’s business, according to a company
statement. While references to Franck’s veterinary business have been removed
from the company’s website, court documents filed by the FDA reveal that
Franck's has $8 million in annual gross sales with $3.5 million of that derived
from veterinary products. Franck’s filled more than 37,600 prescriptions for
animal use between Feb. 1 and Dec. 4, 2009.
In terms of Franck's veterinary products, the company specializes in equine
and small animal drugs. Members of the Veterinary Information Network (VIN)
have expressed concern that they’ve lost a source for compounded versions of calcitriol,
though a variety of board discussions reference Franck’s as a supplier of many
other compounded medications.
Publicly addressing the needs of veterinarians, Franck's states: “We are
working with FDA to resolve this issue as quickly as possible to determine
whether it will permit us to resume compounding of these important veterinary
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