In New National Poll, Veterinarians Report That FDA’s Proposed Guidance Will Have a Significant Negative Impact on Animal Patients.
Swedesboro NJ—(BUSINESS WIRE)—A new nationwide poll of veterinary practices confirms that new guidance proposed by the Food & Drug Administration (FDA) would have a significant negative impact on their practices and their patients’ health if issued and enforced. The poll began on December 18, shortly after FDA released its proposed “Compounding Animal Drugs from Bulk Substances Guidance for Industry #256” for public comment. The results of the survey as of January 6, 2020, are available at MyMedsMatter.com. The survey is still open as of this release.
The survey reports on the responses of 1,849 veterinary professionals in the U.S., 78% of whom practice in small businesses with four or fewer veterinarians; 70% of respondents treat primarily companion animals. For 99.4% of those responding, having access to compounded medications when they are necessary in their medical judgement is important.
A coalition of compounding pharmacies that specialize in veterinary medicine conducted the research to learn how practicing veterinarians would be affected if FDA’s proposed guidelines were to be finalized. Although, even if issued, this draft FDA guidance is not binding on FDA, compounding pharmacies, or veterinarians, and will not be the law, FDA uses non-binding Guidance as the basis for its enforcement actions.
Marcy A. Bliss, President and CEO of Wedgewood Pharmacy said: "Once again, veterinarians have reiterated the importance of compounded medication for animal patients and don't see the need for change or the benefits of federalizing what are now the state-regulated practices of pharmacy and veterinary medicine. 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 The 2015 guidance was withdrawn in 2017 following significant pushback from the veterinary and pharmacy professions, state pharmacy and veterinary organizations, and demands for withdrawal from members of Congress.
FDA's proposal would change the way medication 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 increase costs an average of 300%, decrease quality, increase risk, and dramatically reduce the availability of compounded medications, which are regularly prescribed by 99% of veterinarians, to meet the needs of difficult-to-treat patients. FDA has failed to show any studies or evidence that this new regulatory scheme will improve safety. The guidance proposes significant changes to the practices of pharmacy compounding and veterinary medicine, all of which respondents overwhelmingly say will have a negative impact on their practices and patients. They would:
- Increase the average price of compounded medications by 300% if veterinarians or compounding pharmacies are required to compound from finished pharmaceutical goods instead of bulk active pharmaceutical ingredients (APIs): 98% say this provision would have a negative impact;
- Limit bulk APIs that can be used for compounding to a starting positive list of seven items—many fewer than the 450 that are the current standard of care: 96% say this provision would have a negative impact;
- Prohibit veterinarians from prescribing a compounded medication from APIs if there is a manufactured drug that contains the same active ingredient. For example: needing to prescribe an FDA-approved unflavored human tablet vs. having the option to prescribe a flavored oral suspension prepared 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 listed 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 need for a compounded medication that is made from a APIs as opposed to a manufactured drug: 90% say this provision would have a negative impact;
These documentation requirements in the FDA guidance include sweeping new restrictions for writing prescriptions, even though FDA has no authority to regulate the practice of medicine. Yet, the guidance calls for a state-licensed prescriber to include a detailed explanation on each prescription and in the medical record why there is a “clinical need” for the compounded medication instead of an FDA-approved drug. If the FDA guidance is adopted, veterinarians will be the only medical professionals FDA expects to justify how they are making medical decisions for their patients.
Comments from veterinarians in the survey make it clear that veterinarians have negative 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, this requires an extensive range of dosages, which often cannot be achieved utilizing currently manufactured drugs. Compounding allows me to acquire formulations of drugs in volumes that can be successfully administered.”
“As a board-certified specialist who uses compounded medications every day, they are critical to achieving proper medical care for my patients. Approximately 25% of my commonly used ophthalmics are compounded and ARE NOT available in the human pharmacy markets. Veterinary patients are at great risk for serious HARM and fewer medical treatment options if our ability to prescribe and dispense compounded medications is altered.”
“It is frequently challenging to find drugs in sizes and formulations that can be given to our vet patients as most are designed for human market. Having the ability to get compounded drugs is a Godsend to vets, their clients, and the patient. If compounding options were not available, many of my patients simply would not be getting the medication, period.”
A coalition of the largest pharmacies serving veterinarians and animal patients in the U.S. commissioned the study. The survey results, including thousands of comments by veterinary professionals, are available at MyMedsMatter.com.