Document ID: FDA-2011-N-0656-0037
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-07-02T04:00Z

Summary of views and comments received regarding proposed recommendations for ADUFA V

Docket No. FDA-2011-N-0656
 June 2021

Introduction

The Animal Drug User Fee Act (ADUFA) authorizes the Food and Drug Administration (FDA) to collect user fees for the review of animal drug applications.  The reauthorization of ADUFA IV expires on October 1, 2023.  FDA began the reauthorization process, in preparation for ADUFA V, with a public meeting held on May 20, 2021.  A docket was opened and will remain open until December 1, 2022, for the public to submit written comments. 

Background

The statutory language of ADUFA states:

   ``(d) REAUTHORIZATION. --  
       ``(1) CONSULTATION. -- In developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for the process for the review of animal drug applications for the first 5 fiscal years after fiscal year 2013, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with --  
          ``(A) the Committee on Energy and Commerce of the House of Representatives; 
          ``(B) the Committee on Health, Education, Labor, and Pensions of the Senate; 
          ``(C) scientific and academic experts; 
          ``(D) veterinary professionals; 
          ``(E) representatives of patient and consumer advocacy groups; and 
          ``(F) the regulated industry. 
       ``(2) PRIOR PUBLIC INPUT. -- Prior to beginning negotiations with the regulated industry on the reauthorization of this part, the Secretary shall --  
          ``(A) publish a notice in the Federal Register requesting public input on the reauthorization; 
          ``(B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a); 
          ``(C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and 
          ``(D) publish the comments on the Food and Drug Administration's Internet Web site.

Summary of Public Comments

As of June 20, 2021, FDA has received three comments: two from consumer advocacy groups and one from regulated industry.  Commenters noted the importance of the ADUFA program to ensuring continued strong commitment to the safety and efficacy of new and existing new animal drugs.  
One consumer advocacy group (1) stated their support of the implementation of the FDA's judicious antimicrobial use guidance documents #209 and #213; and (2) commented that the reauthorization process should not be used to advance post-market approval activities that could potentially threaten successful Congressional reauthorization of ADUFA.  
Another consumer advocacy group (1) asked FDA to consider ADUFA funding to monitor the unethical and illegal marketing of veterinary drugs; (2) stated that NARMS and efforts to collect sales and use data of antimicrobials fall under activities included in the process for the review of animal drug applications and therefore should receive funding; and (3) stated that FDA must ask Congress to support the use of ADUFA funds to inform science-based decision making. 
Regulated industry commented that they will strive for enhancements in ADUFA V to strengthen FDA/sponsor interactions, increase productivity, promote consistency, and create accountability to bring safe and effective products to the market.  They are in support of the goals laid out in the Foods and Veterinary Medicine Strategic Plan and will work with FDA to use ADUFA V to help move the program closer to achieving these results.  Regulated industry would also like to collaborate with CVM to adopt a more "risk-informed" and "risk-appropriate" approach to the animal drug review process.  They stated that a priority for ADUFA V should be to protect animal and human health by establishing a risk-appropriate and efficient review and approval process, like that of other regulatory authorities.  They feel this process must allow for safe and effective innovative therapies to be brought to market in an expeditious manner to address a wider range of animal health needs.

Conclusion

The process for the reauthorization of ADUFA has benefited from opportunities for
stakeholders to provide input on recommendations with respect to the goals of ADUFA V.  FDA greatly appreciates the substantive and thoughtful input provided by stakeholders at the public meeting in addition to the docket comments described above.  This input will help FDA better understand and incorporate stakeholder perspectives and priorities and will contribute to a stronger set of proposed recommendations.