Species Animal Health Act

Slide 1:Overview ofThe Minor Use / Minor Species Animal Health Act

International Workshop on Minor Use and Minor Species (MUMS): A Global Perspective Andrew J. Beaulieu, DVM Center for Veterinary Medicine, FDA October, 2004

Slide 2:Components of an FDA New Animal Drug Approval

Effectiveness Target Animal Safety Human Food Safety Environmental Safety Manufacturing Labeling Freedom of Information Summary

Slide 3:Minor Use/Minor Species

Usually supplements to existing  approvals for major species (horses, cattle, pigs, chickens, turkeys, dogs,  or cats) No need to repeat basic toxicology  information, manufacturing information,  or other information common to both  claims

Slide 4:Minor Use/Minor Species

Still required to demonstrate effectiveness and target animal safety Must show antimicrobial safety, if an antimicrobial Environmental - often a categorical exclusion, but an EA is needed for an aquaculture drug Other requirements remain the same

Slide 5:Historical Perspective

The Animal Drug Availability Act (ADAA) of 1996 required FDA to address minor species animal drug needs FDA published a report outlining proposals to address the problem (10/10/98) A coalition of interested groups drafted legislation to implement the proposals CVM provided �technical assistance� during passage of MUMS Animal Health Act of 2004

Slide 6:Provisions in the New Law

Definitions � minor use/minor species (MUMS) Residue depletion studies provide exclusivity Major species approvals not at risk

Slide 7:Provisions in the New Law

Conditional drug approval process Index for legally-marketed unapproved drugs Designation � increased incentives Unapproved drugs easier to remove Office of Minor Use/Minor Species Animal Drug Development

Slide 8:Definitions

Major species � means cattle, horses, swine, chickens, turkeys, dogs, and cats Minor species � means animals, other than humans, that are not major species Minor use � means the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals, or in limited geographical areas and in only a small number of animals annually

Slide 9:New Exclusivity Provision

Residue depletion studies now considered �significant new data� for granting of 3 or 5 years of marketing exclusivity for Minor Species or Minor Use approvals Currently, only effectiveness and target animal safety studies qualify to get this marketing exclusivity

Slide 10:Scope of Review

for MUMS applications � assurance to industry that a MUMS supplement to an existing approval will not subject existing approved claims to new scrutiny this fear can discourage sponsors from supporting MUMS projects this assurance does not constitute reaffirmation of the parent application nor does it prevent FDA from reopening any application for cause

Slide 11:MUMS Conditional Drug Approval

Would not call for change in data standards � full NADA approval requirements Marketing allowed while effectiveness component is completed (up to 5 years) provided there is a reasonable expectation of effectiveness and all safety components are complete Labeling must indicate conditional status

Slide 12:MUMS Indexing

No other practical means to legally provide drugs for these species � zoo animals, pocket pets, lab animals � Legal extra-label use not meeting needs no approved products or useful formulations Legally-marketed, but NOT approved Better than either no drugs or no control

Slide 13:Indexing continued

2-step process CVM reviews requests for indexing and OKs a proposed expert panel Outside expert panel assesses the safety and effectiveness of the product CVM endorses expert panel decision and �indexes� safe & effective products Product can be easily removed from the index if problems emerge

Slide 14:Indexing continued

Benefits animals, pet owners, farmers, veterinarians, pharmaceutical companies, zoo and wildlife biologists, FDA and other government agencies by making drugs for which safety, effectiveness and labeling have been assessed by experts legally available

Slide 15:Designation

For unique MUMS products Modeled on human �orphan drugs� Extended periods of marketing exclusivity(7 years) Grants for studies to support approval Potential tax breaks� not in current law

Slide 16:Remove Illegal products

Illegal products compete unfairly with products that have gone through the approval, conditional approval or indexing process A level playing field encourages sponsors

Slide 17:Which products are legal?

NADA approved Conditionally approved Indexed Subject to a regulation establishing Generally Recognized as Safe/Effective (GRAS/GRAE) Allows easy identification of illegal products for regulatory action

Slide 18:MUMS Office

Created an Office of MUMS Animal Drug Development reporting to Center Director Personnel to administer grants, review designation and indexing requests Liaisons to MUMS community and the regulated industry

Slide 19:Importance of the Law

Encourages participation in an array of MUMS drug review processes � animal drugs should be demonstrated to be safe and effective prior to marketing Provides a legal alternative to the formal approval processes for products for very small and/or specialized markets (zoo, lab, exotic animals) Simplifies removal of illegal products from the market

Slide 20:Encourage Approvals

The designation process and its incentives should encourage MUMS approvals The MUMS Office will provide assistance and guidance Conditional approval will allow sponsors to recoup some investment prior to complete approval Protection of existing approvals encourages supplements

Slide 21:Legal Marketing

The Indexing process will provide an alternative to the full approval process for certain MUMS products Gives FDA additional information and control of these products Provides consumers with better information and confidence in these products Limited to products with no human food safety concern

Slide 22:For More Info

Contact Meg Oeller at FDA/CVM(301) 827-3067 or moeller @cvm.fda.gov Contact Andrew Beaulieu at FDA/CVM (301) 827-2954 or abeaulie @cvm.fda.gov

Slide 23:www.fda.gov/cvm

Check CVM�s Website for the most current information