Franck’s Pharmacy negotiates with FDA in Washington on veterinary compounding

Outcome could have broad effects on industry, some contend

May 20, 2010 (published)
By Jennifer Fiala

Franck’s 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 in Washington.

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 compounding.”

Officials with the FDA’s Center for Veterinary Medicine could not immediately be reached.

A Joint 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 control procedures.

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 June 10.

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 efficacy.

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 injunction.    

"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 medicines.”

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