ADUFA Stakeholder Meeting
February 23, 2017
10:30 a.m. – 11:30 a.m.
Rockville, MD and via WebEx
Section 740A(d)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that at least every 4 months during negotiations with regulated industry FDA will hold discussions with public stakeholders, including representatives of veterinary, patient, and consumer advocacy groups, at which the public may present its views on the reauthorization, including specific suggestions for changes. The purpose of the meeting was to update stakeholders on the progress of the ADUFA IV negotiations and for FDA to gather input from stakeholders on their views on the reauthorization and recommendations for the program. This meeting satisfies the requirement for periodic consultation with public stakeholders in section 740A(d)(3) of the FD&C Act.
- Roxanne Schweitzer, Center for Veterinary Medicine (CVM)
- Steve Vaughn, CVM
- William Flynn, CVM
- Cassie Ravo, CVM
- Sharon Tarbell, CVM
- Petra Garosi, CVM
- Lori Talley, Office of Chief Counsel
- Steve Roach, Food Animal Concerns Trust
- John Curtis, Therio LLC
- Karin Hoelzer, The Pew Charitable Trust
- Nora Wong, The Pew Charitable Trust
- Adrianne Massey, Biotechnology Innovation Organization
- Thomas Gremillion, Food Policy Institute, Consumer Federation of America
- Kathy Vannetta, Elanco
- Angela Anderson, Elanco
FDA provided a brief history of ADUFA performance and financials. FDA provided stakeholders with a timeline for the current ADUFA negotiations. FDA provided an update on the performance enhancements and financial proposals under discussion in the current ADUFA negotiations.
Adrienne Massey from the Biotechnology Innovation Organization stated that she appreciated the willingness to maintain the Barriers to Innovation waiver as this waiver is of great importance to the emerging technology industry.
Steve Roach from the Food Animal Concerns Trust appreciates the enhancements in reporting antimicrobial sales and distribution information and is looking forward to the inclusion of species-specific information in the data that FDA collects from animal drug sponsors. He is looking for an expansion of the program to look at Veterinary Feed Directive distribution data and sales data. He is interested in seeing ADUFA funding used for post approval activities such as NARMS and collection of sales data. Mr. Roach inquired about the work on Animal Drug Availability Act (ADAA) combinations. FDA stated that the discussion on the ADAA combinations is exclusively related to the review process and would in no way change any of the standards for approval.
Thomas Gremillion from the Consumer Federation of America and Safe Food Coalition expressed concern about the inappropriate use of antibiotics, food safety, and foodborne illness. Mr. Gremillion would like to see expanded data collection under Section 105 of ADUFA that would enable us to better gauge where to focus future data collection and determine targets of public health concern. He would like FDA to consider a prohibition on disease prevention claims and include durations of use on antibiotics of human medical importance.
Continued Open Comment Period
Public comments will be accepted through December 2017, electronically via the Federal eRulemaking Portal https://www.regulations.gov, or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20952. All comment submissions received must reference Docket No. FDA-2011-N-0656 for ADUFA.