Suitability Petitions Dr. Ken Harshman, Director Division of Generic Animal Drugs Center for Veterinary Medicine AAVPT Workshop Veterinary Drug Regulatory Life Cycle (A to Z) March 2, 2011 Suitability Petition (SP) A suitability petition is a means for a person to request FDA approval to be able to submit an abbreviated new animal drug application (ANADA) for a proposed generic new animal drug that differs from a reference listed new animal drug (RLNAD). Approved SP = permission to seek approval of the proposed generic drug with the requested change Provided for under the Federal Food, Drug, and Cosmetic Act, section 512(n)(3) Suitability Petition What & Where? A type of citizen petition submitted in compliance with 21 CFR 10.30 requesting FDA to approve or disapprove a specific change The request and FDA s response are publicly disclosed Submitted to Division of Dockets Management* *Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 www.fda.gov/regulatoryinformation/dockets/default.htm 1
Suitability Petition Why? Provides a means for innovation with generic new animal drugs within specific defined limits SP is a request to submit an ANADA for a proposed generic new animal drug that is not identical to a RLNAD SP must be approved prior to submitting an ANADA Suitability Petition When? Permissible changes Change in route of administration; Change in dosage form; Change in strength (concentration); or Change in one of the active ingredients in a combination new animal drug; (same pharmaceutical class) OR Change in one of the Type A medicated articles in a feed use combination new animal drug. More than one change can be requested at one time. Suitability Petition How? Petition must contain information to show: Identification of the proposed generic product and a description of the permissible change(s) being requested; Identification of the RLNAD, including dosage form; strength, & active ingredient(s); and Comprehensive statement of grounds (justification) for the proposed change from the RLNAD being requested. 2
Suitability Petition How? Draft labeling for the generic new animal drug that is the subject of this petition and currently approved labeling for the RLNAD. Request for a categorical exclusion from the requirement to prepare an environmental assessment. Certification that this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition. FDA will approve or disapprove a suitability petition no later than 90 days after the date such petition is submitted. FDA will approve a suitability petition unless: Investigations must be conducted to show the safety or effectiveness of the proposed generic new animal drug because of the proposed permissible change(s); or Investigations must be conducted to show the safety for human consumption of any residues in food because of the proposed permissible change(s); or FDA has determined that the RLNAD has been discontinued from sale for safety or effectiveness reasons; or RLNAD has been voluntarily withdrawn from sale and the agency not yet determined whether the withdrawal is for safety or effectiveness reasons; or 3
The petition seeks to change an active ingredient in a proposed generic new animal drug that contains a single active ingredient; or The petition seeks to change more than one active ingredient in a proposed combination generic new animal drug; or Any of the proposed changes from the RLNAD would necessitate significant labeling changes and jeopardize the safe or effective use of the product. Suitability Petition Sponsor Action Post SP approval action: Call to discuss next steps in project development plan Begin drug approval process Open a generic investigational new animal drug (JINAD) file Submit an ANADA Post SP approval action: FDA may, at any time during the course of its review of an ANADA, request additional information to evaluate the change approved in the petition. FDA may withdraw approval of a suitability petition if FDA receives any information demonstrating that the petition no longer satisfies the conditions under which FDA approved it. 4
Suitability Petition Common Problems Failure to contact CVM prior to submitting the SP Not required To determine whether the RLNAD is appropriate To ensure all components of the petition are included Failure to provide adequate justification for the proposed change(s) Suitability Petition Additional References CVM Policy Letter No. 2: Format and content for suitability petitions www.fda.gov/ohrms/dockets/dailys/03/dec03/121 203/03n-0324b-sup0001-17-Tab-16-vol2.pdf Opens to a blank page; scroll down to reference 21 CFR 314.93: Petition to request a change from a listed drug. Contact Information Dr. Ken Harshman, Director Division of Generic Animal Drugs 240-276-8197 john.harshman@fda.hhs.gov 5