APC leaders met Tuesday afternoon with FDA Center for Veterinary Medicine Director Dr. Steven Solomon and his lieutenants to discuss our concerns with draft GFI #256 on animal compounding that was released back in November.
"We view this draft GFI as yet another effort by FDA to regulate without clear statutory authority and outside the regulatory rule-making process, and we made that point to Dr. Solomon and his team," said APC President Shawn Hodges.
Representing APC at the meeting were President Shawn Hodges of Kennesaw, Georgia; Board Chair Jennifer Burch of Durham, NC; Legis & Regulatory Chair Anthony Grzib of Swedesboro, NJ; Wedgewood Pharmacy CEO Marcy Bliss of Swedesboro, NJ; and APC's CEO Scott Brunner, CAE.
"Solomon and his team seemed genuinely interested in our concerns and perspective. They asked several questions and took lots of notes. That's a hopeful sign," said APC's Brunner.
The new draft is similar to a previous guidance issued by FDA in 2015 that was withdrawn in 2017 after complaints from veterinarians, pharmacy organizations, pet owners and congress that it exceeded FDA's statutory authority, interfered with the state regulated practice of veterinary medicine and pharmacy, and endangered the health of companion and exotic animals.
In brief, draft GFI #256:
- Requires use of the FDA-approved products as the source of API unless there is a clinical need that requires avoidance of that product.
- Requires veterinarians to document on the prescription that the compounded drug produces a clinical difference in that a manufactured drug cannot provide for their animal patient and that there is medical rationale for the prescription.
- Would restrict veterinarians' ability to obtain compounded medications for office use from a compounding pharmacy even if state law allows it, compromising animal health and patient treatment.
The new draft borrows extensively from the Drug Quality & Security Act, which is expressly limited to human health. "We think it's a leap to try to apply those principles to animal health in a way that Congress didn't intend or authorize," Brunner said in the meeting.
If their questions and note-taking are any indication, Solomon's team seemed most interested in the following points raised by APC in the meeting:
Read the talking points we used at the meeting.
- Starting with finished goods may not be in the best interest of the patient for several clinical and formulation reasons, in addition to higher financial costs to patients.
- How much compounders know about the APIs we use (regarding potency and purity based on the CofA and internal identity testing).
- The frequency and chronic state of backorders in animal health manufacturing.
- That many distributors and manufacturers won't sell compounders finished goods for compounding.
- The veterinarians' perceptions about the negative health impact on humans.
- The idea that the GFI will limit access.
APC will be offering formal comments on GFI #256 prior to the February 18 deadline.
WHAT YOU CAN DO: Submit comments on the GFI to FDA.