Animal Drugs Initiative Elizabeth Luddy, DVM Deputy Director Office of New Animal Drug Evaluation Center for Veterinary Medicine Animal Drugs Initiative Publically launched December 20, 2010 drugs webpage Letters to Veterinary and Pharmacy Professionals Federal Register notice Animal Drug Initiative Based on available information, FDA determined that some of these animal drug products did not raise safety concerns Many are the subject of enforcement discretion or compliance policy guides 1
Animal Drug Initiative Consistent supplies of quality drugs are needed to meet animal health needs Need stable, legal pathway for certain currently marketed unapproved animal drugs, e.g. injectable vitamins, various topical solutions and first aid products, shampoos, electrolyte and glucose solutions, antidotes Animal Drugs Webpage http://www.fda.gov/animalveterinary/guidancecomplianceenforcem ent/complianceenforcement/animaldrugs/default.htm Animal Drugs Webpage What are unapproved animal drugs? FDA s concerns about unapproved animal drugs Animal drugs illegally marketed as animal devices 2
What are Animal Drugs? Animal drugs illegally marketed in the United States that have not been approved by the Food and Drug Administration (FDA) animal drugs have not been reviewed under FDA's approval process Legal Marketing of New Animal Drugs To be legally marketed, a new animal drug must be the subject of an approved new animal drug application (NADA) an approved generic application [abbreviated new animal drug application (ANADA)] a conditional approval or an index listing FDA s Concerns About Animal Drugs No pre-approval review No post-approval monitoring May unfairly compete against approved animal drugs 3
Animal Drugs Illegally Marketed as Devices Circumvents the pre-approval drug review process and post-approval monitoring No pre-market review for devices No requirement for post-approval reporting If it relies on a chemical action occurring in or on the animal s body to work, the product is a drug, not a device If it needs to be metabolized by the animal s body to work, the product is a drug, not a device Questions About Jurisdiction Drug vs. Device Contact Vernon Toelle Division of Compliance 240-276-9238 Drug vs. Biologic or Drug vs. Pesticide Contact Vitolis Vengris Division of Surveillance 240-276-9063 Letters to Veterinary and Pharmacy Professionals http://www.fda.gov/animalveterinary/safetyhealth/productsaf etyinformation/ucm182036.htm 4
Letters to Veterinary and Pharmacy Professionals Letters to veterinarians and pharmacists alerting them to recent product approvals Currently letters for trilostane, phenylbutazone and domperidone with others to be added These drugs are approved and available for veterinary use in the US and the drugs should not be imported from other countries or compounded from bulk The drugs can only be legally compounded by using FDA-approved product as the starting material Federal Register Notice Solicit comments from stakeholders, including the regulated industry, veterinary professionals, and the public Focus is not on revising the current new animal drug approval process Federal Register Notice Explore additional mechanisms that use FDA s existing regulatory framework as well as novel strategies not currently used to increase the number of approved or otherwise legally marketed animal drugs Also requesting comment on the use of limited enforcement discretion as an element of the overall strategy 5
Federal Register Notice The continued availability of a number of these products is important to meet the health needs of animals Necessary to continue to exercise enforcement discretion for certain essential unapproved animal drugs or categories of products as the Agency works to develop new ways to increase the availability of products that are approved or otherwise legally marketed Next Steps The comment period ended February 18 possible extension FDA will consider all comments Look for additional updates on the Drugs Webpage THANK YOU Elizabeth Luddy, DVM elizabeth.luddy@fda.hhs.gov 240-276 276-8312 6