FDA Will Treat Animal Patients: The Veterinary Case

A new public poll of veterinary studies proves that new administration recommended by the Food & Drug Administration (FDA) would have a meaningful negative impact on their practices and their sufferers’ health if published and enforced.

The poll began on December 18, shortly after FDA released it is proposed “Compounding Animal Drugs from Bulk Substances Guidance for Industry #256” for public comment. The completion of the survey as of January 6, 2020, are accessible at MyMedsMatter.com. The research is still open as of this statement.

The survey answers on the acknowledgments of 1,849 veterinary specialists in the U.S., 78% of whom practice in small businesses with four or fewer veterinarians; 70% of respondents treat guide animals primarily. For 99.4% of those responding, having access to complicated medications when they are needed for their medical judgment is essential.

A coalition of compounding pharmacies that specialize in veterinary medicine conducted the research to learn how practicing veterinarians would be concerned if FDA’s proposed guidelines were to be settled. However, even if announced, this draft FDA leadership is not binding on FDA, compounding medicines, or veterinarians, and will not be the law, FDA uses non-binding direction as to the basis for its implementation actions.

The Compounded Medicine

Marcy A. Bliss, President, and CEO of Wedgewood Pharmacy stated: “Once again, veterinarians have reiterated the value of compounded medicine for animal sufferers and don’t see the requirement for change or the interests of federalizing what are now the state-regulated practices of pharmacy and veterinary practitioners. As one veterinarian put it, ‘This is a solution looking for a problem.’”

The guidance, which has no basis in any law, is very similar to FDA guidance issued in 2015. The 2015 guidance was withdrawn in 2017 following meaningful pushback from the veterinary and drugstore professions, state medicine and veterinary systems, and demands for withdrawal from members of Congress.

FDA’s plan would change the way medicine is prepared for difficult-to-treat patients, those whose needs cannot be met by “off the shelf” alternatives. In addition to making the medication less palatable, this change will raise costs an average of 300%, decrease quality, increase risk, and dramatically reduce the availability of combined medications, which are regularly prescribed by 99% of veterinarians, to meet the needs of difficult-to-treat sufferers.

FDA has abandoned to show any reasoning or evidence that this new administrative scheme will improve safety. The administration proposes meaningful changes to the practices of medicine compounding and veterinary medication, all of which respondents overwhelmingly say will harm their methods and sufferers. They would:

• Improve the average price of combined drugs by 300% if veterinarians or compounding medicines are required to compound from accomplished pharmaceutical assets instead of bulk active pharmaceutical ingredients (APIs): 98% say this provision would have a contradictory influence;
• Limit bulk APIs that can be used for mixing to a starting positive list of seven items—many fewer than the 450 that is the current model of care: 96% say this provision would have a neutralizing impact;
• Prohibit veterinarians from ordering a compounded medication from APIs if there is a printed drug that contains the same active component. For instance: need to define an FDA-approved unflavored human tablet vs. having the option to specify a flavored oral suspension made from bulk active pharmaceutical ingredients: 96% say this provision would have a negative impact;
• Prohibit any compounding from bulk active pharmaceutical ingredients using the 11 APIs currently registered on the FDA’s proposed “negative list”: 94% say this provision would have a negative impact;
• Require veterinarians to document on every prescription and in every medical record why there is a clinical requirement for a combined medication that is made from an APIs as opposed to a completed drug: 90% say this provision would have a negative impact.

These documentation conditions in the FDA administration include sweeping further restrictions for writing medicines, even though the FDA has no authority to control the practice of medication.

However, the administration calls for a state-licensed prescriber to include a thorough explanation of each prescription and in the medical record why there is a “clinical need” for the increased medication instead of an FDA-approved medication. If the FDA administration is adopted, veterinarians will be the only medical professionals FDA expects to justify how they are making healing arrangements for their sufferers.

Judgments from veterinarians in the survey make it clear that veterinarians have adverse perceptions of federal oversight into what are currently state-regulated practices. These comments are typical:

“I treat a variety of non-domestic species that range in size from 30g to 300kg, and this requires an extended range of dosages, which often cannot be accomplished utilizing currently manufactured medicines.

To Sum Up

Compounding enables me to acquire formulations of medications in volumes that can be actively managed.”

“As a board-certified professional who uses compounded prescriptions every day, they are critical to achieving proper medical care for my patients.

Around 25% of my regularly used ophthalmics is compounded and is not possible in the human medicine markets. Veterinary patients are at great risk for serious harm and fewer medical treatment options if our ability to command and dispense compounded medications is altered.”