September 20, 2011
AVMA asked to acknowledge court ruling in compounding brochure
Some celebrate while others downplay ruling's significance
By: Jennifer Fiala
For The VIN News Service
Compounding pharmacies want the American Veterinary Medical Association (AVMA) to amend its member guidance on compounding in light of a court ruling that quashed the U.S. Food and Drug Administration’s (FDA) attempt to shut down a Florida business and cement its regulation of the industry.
Despite the Sept. 12 verdict, the AVMA is not rushing to alter its brochure titled “Veterinary compounding,” last revised in May. Instead, two of the association's volunteer groups — the Council on Biologic and Therapeutic Agents and its Clinical Practitioners Advisory Committee — will review the case and assess whether members need to be educated about its findings. The brochure has earned flack from compounding pharmacists who’ve accused the AVMA of spreading misinformation about federal laws that supposedly govern compounding, considering a judge just ruled against the notion that the FDA's Center for Veterinary Medicine (CVM) wields power to regulate the practice.
Compounding is important in the animal health arena because it allows veterinarians to order custom-made medications for the special needs of individual patients. Supporters of the FDA CVM's oversight accuse some veterinary compounding pharmacies of selling questionable products and illegally encroaching on the business of pharmaceutical manufacturers by making mimics of FDA-approved medications already in the marketplace.
Because compounded concoctions supposedly are not intended for large populations, compounders are exempt from the FDA’s stringent and costly drug approval processes. Rather, the centuries-old practice of mixing bulk chemicals to create tailored medications for individual use is governed by state pharmacy board regulations.
The precedent-setting decision in United States of America v. Franck's Labs, Inc. represents a loss for the FDA CVM, which has operated in recent years as though its regulatory jurisdiction might include compounding pharmacies. In an 80-page ruling filed in U.S. District Court for the Middle District of Florida, Judge Timothy J. Corrigan chastised the FDA CVM for attempting to use a "non-binding" Compliance Policy Guide, commonly called a CPG, to regulate veterinary compounding pharmacies — a job the agency was not Congressionally authorized to do.
The AVMA's compounding brochure features a full page on the CPG, outlining its parameters under the headline "Federal regulations to follow." On an AVMA blog, Dr. Lynne White-Shim, assistant director of the AVMA Scientific Activities Division, writes: "The real outcome of the ruling is that Franck’s Lab is still able to conduct its business. What will happen next with federal rules and the FDA’s Compliance Policy Guide on Compounding of Drugs for Use in Animals (CPG) is unknown …"
Marcy Bliss, an executive at Wedgewood Pharmacy, a major compounder of veterinary medications in the United States, believes that the AVMA brochure was written to discourage the use of compounded medications. However, she's "encouraged" that the AVMA might consider revising it.
"Especially in light of this recent court decision, it is clear that the current AVMA brochure does not give the practicing veterinarian accurate information,” she writes in an email to the VIN News Service. "This court decision underlines the simple truth that almost every practicing veterinarian knows: For difficult to medicate patients and in situations where there is a manufacturer’s backorder, access to compounded medications is very important to their practice and patients."
Downplaying the ruling’s significance is the Animal Health Institute (AHI), a group representing pharmaceutical manufacturers that is partly responsible for the development of the AVMA's compounding brochure.
“There’s a very murky legal situation in terms of compounding, and this case does very little to clear it up,” says AHI spokesman Ron Phillips, alluding to a variety of court decisions on compounding that he believes conflict. “This is certainly not the end of the line, and it’s not a definitive case."
So far, the FDA CVM is mum about whether the agency might appeal the ruling. If the agency goes that route, the next stop is the 11th Circuit Court of Appeals, with jurisdiction covering Georgia, Florida and Alabama.
Roger Morris, a lawyer and registered pharmacist who lectures at Arizona State University's law school and Midwestern University's pharmacy college, predicts that the FDA will seek a higher judicial opinion in the matter.
"What I told students is that this case gives some hint of clarity on this issue of veterinary compounding, if it stands. We'll see if it's appealed," he says.
AHI’s Phillips expects that the U.S. Supreme Court eventually will be petitioned to hear the case or another like it:
“Compounding is clearly a state regulated activity, but manufacturing is clearly federally regulated. What the judge said was that the FDA has not ever drawn a clear line between state regulated compounding and illegal manufacturing."
VIN News Service commentaries are opinion pieces presenting insights, personal experiences and/or perspectives on topical issues by members of the veterinary community. To submit a commentary for consideration, email firstname.lastname@example.org.
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