Animal Drug Approval Based Only on Published Literature is Challenging
(Thursday, March 23, 2023)
FDA allows animal drug approvals based entirely on published literature provided the selected publications adequately justify the specific claims in the market approval application and meets well-established scientific quality standards. Published literature lacks several quality standards essential for regulatory acceptance as sole evidence. FDA’s latest guidance on the topic lists those challenges and suggests ways for the applicants to address them. Published literature forms an important part of animal drug development approval applications. It has been used to support dose and dosing regimen, prediction of potential adverse effects, and substantial evidence of effectiveness. However, so far, published literature was almost always used only as supporting additional information, not as the sole evidence. But it can be, theoretically. In its newest Guidance document on the use of published literature to support market approval of veterinary drugs, FDA lists the limitations of published literature such as lack of GLP standards, differences between hypothesis generating work versus evidence generation for safety and effectiveness claims, limitations of peer review compared to regulatory review, lack of the details of the study design, data disclosure, and reproducibility of data in published articles. For an applicant intending to use a single or few published articles to support market approval, all the above need to be addressed for FDA acceptance. In cases where multiple published reports are used to support safety and effectiveness claims, the type of review of literature could define the useability of the available supporting information. The guidance list conditions for four approaches used for the reviews of large volumes of published literature providing tips for effective summarization of data in publications for regulatory acceptance. FDA recommends that a sponsor discuss its approach for analyzing data from published literature in early submissions to get FDA feedback prior to full analysis. These early reviews would allow FDA to provide feedback that would help further submissions by the applicant. This is one of the most comprehensive guidance on using published literature in regulatory discussions. While the guidance is specific for animal drug applications, the principles described herein can be used broadly for other kinds of regulatory submissions as well.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC