August 17, 2018
On August 14, 2018, H.R. 5554, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 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 and Drug Administration. These two user fee programs enhance the 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.
The bipartisan legislation reauthorizing ADUFA and AGDUFA builds on the success of previous authorizations and 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 the FDA’s progress in bringing all approved antimicrobial animal drugs that are medically important under veterinary oversight. The reauthorizations also coincide with the 50th anniversary of the establishment of section 512, “New Animal Drugs,” in the Federal Food, Drug, and Cosmetic Act, as part of the Animal Drug Amendments of 1968.
Conditional approval has previously been limited to animal drugs intended for use in minor species (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 additional time (up to 5 years) to fully demonstrate effectiveness and, in the interim, the sponsor can market the drug provided 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. The pathway requires annual review of the conditional approval to determine whether the sponsor is making sufficient progress toward meeting the effectiveness standard for full approval.
The legislation has expanded the conditional approval pathway to allow certain additional drugs that are not MUMS drugs to qualify, 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.
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. In addition, the legislation requires that the Government Accountability Office conduct a study to ensure that expanded conditional approval is being utilized appropriately, so that Congress, the FDA, and stakeholders can evaluate the expanded conditional approval pathway prior to its sunset.
The legislation also includes a requirement for the FDA to submit a report to Congress by September 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 (e.g., injectable, tablet) remain available over-the-counter.
The provisions in the legislation regarding animal food additive petitions (FAPs) require the FDA to post to the agency website no later than one year after enactment of the reauthorization legislation (i.e., by August 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 the FDA requires any additional studies from the petitioner, the agency must provide the scientific basis when making such a request. The legislation also directs the agency 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.
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 October 1, 2018. The 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. The FDA’s Center for Veterinary Medicine has also set up an electronic submissions support team to provide timely assistance to animal drug sponsors.
The legislation also mandates that, by September 30, 2023, all approved animal drug products carry a statement stating, “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 and Drug Administration. THIS PRODUCT IS INDEXED--MIF #' (followed by the applicable minor species index file number and a period) Extra-label use is prohibited.” Indexed drugs have gone through a different review process which is restricted to uses in non-food minor species or uses in the early, non-food life stage of certain food-producing minor species.
Congress first approved the user fee program for new animal drugs under the Animal Drug User Fee Act of 2003, and the user fee program for generic new animal drugs under the Animal Generic Drug User Fee Act of 2008. Both programs must be reauthorized every five years. With the enactment of H.R. 5554, these programs are now reauthorized for fiscal years 2019 through 2023.
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