On Aug. 14, 2018, the Animal Drug & Animal Generic Drug User Fee Amendments of 2018 (H.R. 5554) was signed into law to reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) programs administered by the U.S. Food & Drug Administration.

These two user fee programs enhance FDA’s ability to maintain a predictable and timely animal drug review process, foster innovation in drug development and expedite access to new therapies for food-producing and companion animals, FDA said.

In addition to reauthorizing ADUFA and AGDUFA, the bipartisan legislation includes several additional provisions, including a limited expansion of the conditional approval pathway for certain new animal drugs, a requirement to post on the agency’s website the number of pending petitions for food additives intended for use in animal food and a requirement to report on FDA’s progress in bringing all approved medically important antimicrobial animal drugs under veterinary oversight, the agency said.

The reauthorizations also coincide with the 50th anniversary of the establishment of section 512, “New Animal Drugs,” in the Federal Food, Drug & Cosmetic Act, as part of the Animal Drug Amendments of 1968.

Conditional approvals. According to FDA, conditional approval previously was limited to animal drugs intended for use in minor species — i.e., those other than horses, dogs, cats, cattle, pigs, turkeys and chickens — or for minor uses in major species (MUMS drugs). This alternative pathway to approval provides the drug sponsor with additional time (up to five years) to fully demonstrate effectiveness, and in the interim, the sponsor can market the drug provided that a reasonable expectation of effectiveness has been demonstrated and the sponsor has satisfied all other requirements for a full animal drug approval, such as safety and manufacturing requirements.

FDA said the reauthorization legislation has expanded the conditional approval pathway to allow certain additional drugs to qualify that are not MUMS drugs, but this expanded pathway is limited to drugs intended to treat serious or life-threatening diseases or conditions or address unmet health needs and for which effectiveness demonstration would require complex or particularly difficult studies. The legislation stipulates that the new conditional approval pathway cannot be used for antimicrobial drugs, FDA said.

In addition, the legislation mandates that the expansion of conditional approval sunset after 10 years, to coincide with the reauthorization of the animal drug user fee programs in 2028.

Veterinary oversight. The legislation also includes a requirement for FDA to submit a report to Congress by Sept. 30, 2019, identifying how the agency will incorporate veterinary oversight for all approved medically important antimicrobial drugs administered to animals that are not already subject to veterinary oversight.

Although all medically important antimicrobials used in feed or water for food-producing animals are currently under veterinary oversight, some other dosage form products, such as injectables and tablets, remain available over the counter, FDA said.

Food additive petitions. The provisions in the legislation regarding animal food additive petitions (FAPs) require FDA to post to the agency website no later than one year after enactment of the reauthorization legislation (i.e., by Aug. 14, 2019) the number of pending FAPs, how long each FAP has been pending, including any extensions, the number of study protocols under review by the agency for more than 50 days and the number of protocol reviews that receive an extension from the agency. If FDA requires any additional studies from the petitioner, the agency must provide the scientific basis when making such a request.

The legislation also directs FDA to issue within 18 months from enactment of the reauthorization legislation draft guidance to assist petitioners in engaging with the agency in a voluntary pre-petition consultation process for animal food additives and to finalize, withdraw or reissue the guidance within one year after the end of the period for commenting on the draft guidance, FDA said.

Although most animal drug sponsors currently submit their applications electronically, the legislation mandates electronic submission for all animal drug applications and submissions under section 512(b) or section 571(a) beginning on Oct. 1, 2018. FDA has engaged in significant outreach to assist animal drug sponsors in learning to successfully use the electronic portal, including holding a series of webinars to walk sponsors through the process and answer any questions that may arise.

FDA’s Center for Veterinary Medicine has also set up an electronic submissions support team to provide timely assistance to animal drug sponsors.

Label statements. FDA said the new reauthorization legislation also mandates that, by Sept. 30, 2023, all approved animal drug products carry the statement "Approved by FDA under (A)NADA #" and list their New Animal Drug Application or Abbreviated New Animal Drug Application number. Conversely, products that are listed on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species are no longer required to carry the statement “Not approved by FDA.” Instead, they will carry the statement “LEGAL STATUS — In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved or Indexed by the Food & Drug Administration. THIS PRODUCT IS INDEXED — MIF # (followed by the applicable minor species index file number). Extra-label use is prohibited.”

FDA explained that indexed drugs go through a different review process that is restricted to uses in non-food animal minor species or uses in the early, non-food life stage of certain food-producing minor species.