Reed Smith Client Alerts

On July 14, 2020, the Food and Drug Administration (FDA) issued four draft Guidance for Industry (GFI) documents that represent the agency’s latest efforts to provide additional pathways to navigate the new animal drug approval process (NADA):

  • FDA-2020-D-1396 for draft GFI #265 “Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs”
  • FDA-2020-D-1400 for draft GFI #266 “Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs”
  • FDA-2020-D-1402 for draft GFI #267 “Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs”
  • FDA-2020-D-1401 for draft GFI #268 “Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs”

These draft GFI documents come on the heels of FDA’s recent attempt to assert federal regulatory authority over the state-controlled practice of animal drug compounding (GFI #256, previously covered by this Reed Smith team in this blog post).

Authors: Rachael G. Pontikes Emily L. Hussey David T. Hartmann Kelly J. Kearney

The four GFI documents stem from the Center on Veterinary Medicine’s (CVM’s) July 16, 2019 public meeting entitled “Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs.” As part of FDA’s mandate to innovate the NADA process pursuant to section 305 of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, this forum solicited comments from industry stakeholders and other interested parties on various topics, the lion’s share of which ranged from novel investigation designs and the use of data from foreign countries, to the incorporation of real-world evidence, biomarkers, and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs. The four GFI documents cover distinct topics that – if finalized – are intended to assist animal drug sponsors in navigating newly established tools in the NADA process, and, according to FDA, will encourage animal drug sponsors to use innovative approaches in the quest for approval.

Draft GFI #265, “Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs,” would permit sponsors to incorporate data from foreign countries under certain circumstances in order to support the demonstration of effectiveness of new animal drugs. Additionally, FDA provides guidance as to how sponsors could obtain feedback from CVM about the use of foreign-sourced data in investigations and study protocols for new animal drugs. According to CVM, this GFI reinforces the agency’s commitment to minimizing the need to conduct duplicative domestic studies when foreign data may suffice.

Similarly, draft GFI #266, “Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs,” would allow sponsors to utilize “real-world data” and “real-world evidence” – including ongoing surveillance activities, observational studies, and registry data – into proposed clinical investigation protocols and applications as part of the NADA process. This guidance further describes how CVM intends to evaluate real-world data and real-world evidence in submissions to demonstrate the effectiveness of new animal drugs, as well as how sponsors would obtain feedback from CVM on technical issues related to the use of such data in anticipation of submission.