Comment from Ware Jodi

When I received the FDA CVM announcement regarding the Virtual Public Meeting and Comment Period on Reauthorization of User Fee Programs for Animal Drugs, I promptly asked the CVM which ADUFA User Fee type—Application, Establishment, Product or Sponsor—supports postmarketing surveillance and compliance activities. I was surprised to learn that 1) ADUFA and AGUFA fees support *pre*market animal drug review, and 2) there are currently no user fee commitments or dedicated support for *post*marketing surveillance and compliance. In effect, animal drug sponsors pay to bring their drugs to market and then enjoy the benefits of limited tax dollar funding for postmarketing surveillance and compliance. Another little known fact is that—unlike for human drugs—the FDA lacks several key authorities for animal drugs. Specifically, the FDA cannot: A) Require animal drug sponsors to make safety-related labeling changes based on new safety information that becomes available after approval of an animal drug; B) Require animal drug sponsors to develop and implement a Risk Evaluation and Mitigation Strategy (REMS), a drug safety program for drugs with serious safety concerns and for which interventions beyond FDA-approved labeling are necessary to ensure the safe use of the drug; and, C) Require animal drug sponsors to conduct post-approval studies of animal drugs to assess a known or potential serious safety risk. These authorities were sought in the FDA’s FY2025 Legislative Proposals (www.fda.gov/media/176924/download), but have apparently since fallen by the wayside. Against this backdrop, it is all the more remarkable that significant safety concerns associated with the first monoclonal antibody approved for use in dogs (bedinvetmab/Librela) were identified and addressed within months of its commercial launch. I am grateful that the CVM devoted resources to evaluate these concerns and took action through a Dear Veterinarian Letter to help mitigate risks. I’m afraid if accelerated “innovations” were to become the norm, so could these resource-intensive undertakings. Unless and until postmarketing safety and compliance receive greater priority, calls for increased “innovation” should be tempered by appropriate safeguards. The CVM’s stated mission is to protect human and animal health. We humans and our beloved companion animals deserve meaningful protections from unsafe or ineffective drugs once they reach the market. Without stronger postmarketing oversight, the harms could be significant.