For Industry

March 6, 2012

ADUFA III Negotiation Meeting Minutes

Animal Health Institute (AHI)
1325 G St. NW, Suite 700, Washington DC
March 6, 2012
10:00 am – 2:00 pm

Purpose

To discuss FDA and Industry perspectives on ADUFA III reauthorization, the negotiating process going forward, and planning for future discussions.

Participants

 FDA  Industry 
 Steve Vaughn, CVM Rich Carnevale, AHI 
 Roxanne Schweitzer, CVM Bruce Martin, Bayer 
 Petra Garosi, CVM Chan Baldwin, Abbott 
 Yanming Chae, CVM Grace Gowda, Merial 
 Alexis Nazario-Negron, OFM Kathy Vannatta, Elanco 
 Frank Claunts, Consultant Sam Veluvolu, AHI 
  Tom Schriemer, Pfizer

Recognition of Negotiating Leads

  • Steve Vaughn and David Wardrop are the co-leads representing FDA.
  • Rich Carnevale is the lead representing Industry.
  • AHI will provide a letter certifying they represent the majority of Industry.

Negotiation Ground Rules

  • The ground rules that will govern ADUFA III negotiations were discussed and agreed by both FDA and Industry.

Ratification Process

  • Both FDA and Industry negotiating teams represent their respective parties. However, both parties indicated that they have a higher level of “approvers” hereto referred as Ratifiers.

Timeline

  • FDA’s intentions are to finalize an ADUFA III final proposed agreement by June.

Stakeholder Interests

  • As outlined in section 104(d)(3) of FD&C Act (ADUFA II), FDA must conduct periodic consultation with interested stakeholders.
  • To date, FDA has met with 2 stakeholder groups – Center for a Livable Future, John Hopkins and Keep Antibiotics Working and other associated interested parties. These stakeholders were interested in expanding the amount of data reported under Section 105 and exploring possible mechanisms for collection of antimicrobial drug use data.
  • FDA has also received a few public comments from small sponsors who are concerned that user fees are a detriment to their businesses.

Industry Perspectives on ADUFA III

  • Industry briefly discussed their concerns on increasing time to approval and increasing costs.
  • Industry suggested that ADUFA III will need new incentives for product development by reducing time and overall costs of approval and other barriers to innovation.

FDA Perspectives on ADUFA III

  • FDA discussed the issues with current workload adjuster methodology and proposed modifications. FDA believes that the current methodology does not accurately portray CVM’s workload.
  • FDA presented data to demonstrate that ADUFA review workload was not decreasing (as indicated in the FY 2012 fee rate Federal Register notice) but in fact has remained the same in reality.

Establishment of Future Agendas

  • FDA and Industry agreed that the next meeting on March 16, 2012 would review the financial proposals from both FDA and Industry.
  • Ideas around ways to reduce the review time will be further explored.

 

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