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ICCVAM Biennial Report 2018-2019

ICCVAM Biennial Report 2018-2019
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Policies and Guidance for Implementation of Alternative Methods

To encourage adoption and use of NAMs, the Strategic Roadmap calls on agencies to provide clear guidance on use and acceptance of data from these approaches. During 2018 and 2019, several agencies issued guidance on the use of NAMs in the areas of testing for skin sensitization and carcinogenicity, as well as for the testing of medical devices and vaccines.

Measuring Success in Implementation of Alternative Methods and Reduction of Animal Use

In September 2019, the U.S. Government Accountability Office issued a report, “Animal Use in Research: Federal Agencies Should Assess and Report on Their Efforts to Develop and Promote Alternatives.” The report describes how the U.S. Department of Health and Human Services, USDA, and EPA ensure researchers consider the use of alternatives to animals and examines the steps the agencies have taken to facilitate the use of alternative research methods and to assess the effect of their efforts on animal use. The report recommended that ICCVAM establish a workgroup to develop metrics that ICCVAM member agencies could use to assess progress made toward reducing, refining, or replacing animal use in testing. Furthermore, the report recommended that such metrics be incorporated into ICCVAM Biennial Progress Reports. ICCVAM approved the establishment of a metrics workgroup in November 2019, and the workgroup will develop objectives and a timeline for planned activities during meetings in early 2020.

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Draft Science Policy on Non-animal Methods for Skin Sensitization Testing

In an April 2018 news release, EPA announced a draft science policy to reduce animal use in testing strategies that evaluate chemicals for their ability to cause an allergic reaction, inflammation, or sensitization of the skin. The draft policy was the result of national and international collaboration among ICCVAM, NICEATM, Cosmetics Europe, the European Union Reference Laboratory for Alternatives to Animal Testing, and Health Canada’s Pest Management Regulatory Agency.

Guidance on Microsampling Techniques in Toxicokinetics Studies

In May 2018, FDA announced availability of final guidance on the benefits and limitations of the use of microsampling techniques in toxicokinetics studies. Benefits of these techniques include reducing the numbers of animals needed for these studies. “S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling—Questions and Answers” is available on the FDA website. This international guidance was developed through FDA participation in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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Guidance on Nonclinical Testing of Cancer Drugs

In June 2018, FDA released a Q&A to help stakeholders interpret international guidance on nonclinical evaluation of cancer drugs. The Q&A includes statements about reduction of animal use or use of in vitro alternatives in these studies. S9 Nonclinical Evaluation for Anticancer Pharmaceuticals – Questions and Answers – Guidance for Industry” is available on the FDA website. This international guidance was developed through FDA participation in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The guidance discussed in the Q&A is being implemented by the U.S., the European Union, Japan, Brazil, Singapore, Canada, South Korea, China, Switzerland, and Taiwan, thereby increasing global impact on the 3Rs.

Guidance on Nonclinical Studies of Microdose Radiopharmaceutical Diagnostic Drugs

Small doses of radiolabeled drugs can be used for diagnostic purposes. Such microdoses are defined as 1/100th or less of the dose that would be expected to have a pharmacological effect.

In August 2018 FDA published final guidance on “Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations” that provides recommendations for nonclinical studies of such drugs. The microdose evaluated during early clinical trials is less than or equal to 100 micrograms. Because such low doses are used, the guidance recommends an abbreviated nonclinical program. This guidance is intended to help sponsors facilitate the timely conduct of clinical trials, reduce the use of drug development resources, and reduce the use of animals by specifying study types for which in vitro methods may be used.

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Guidance on Nonclinical Studies and Labeling for Oncology Therapeutic Radiopharmaceuticals

In August 2019 FDA published “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” This guidance provides recommendations for nonclinical studies for therapeutic radiopharmaceuticals for the treatment of cancer, and specifically describes instances where studies are not needed, potentially reducing animal use.

  • When there is experience with the radionuclide or the ligand components of the radiopharmaceutical being developed, the nonclinical program can be abbreviated as needed, and the first-in-human dose can be based on clinical data as appropriate.
  • In general, no toxicity studies are warranted before a first-in-human study when the radiopharmaceutical is a neat radionuclide.
  • In addition, no genetic or reproductive toxicity or carcinogenicity study with the pharmaceutical, in either radiolabeled or nonradiolabeled form, is warranted during drug development or for approval.

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Guidance on Reproductive Toxicity Testing and Labeling Recommendations for Oncology Pharmaceuticals

The FDA guidance document “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations” was finalized in May 2019 and provides information for the development of pharmaceuticals that are intended to treat patients with cancer. The guidance notes that, in some cases, a weight-of-evidence approach showing potential for reproductive toxicity may eliminate the need to conduct a dedicated embryofetal development study. Such weight-of-evidence approaches can consider data from alternative assays, such as fit-for-purpose in vitro, ex vivo, or nonmammalian in vivo assays. The guidance also illustrates other cases where certain developmental and reproductive toxicity testing may not be warranted.

Guidance on Nonclinical Development of Pharmaceuticals for Hematologic Disorders

The FDA guidance document “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals” was finalized in March of 2019. This guidance is intended to streamline the development of pharmaceuticals used to treat patients with serious noncancer hematologic disorders such as sickle cell disease, hemophilia, and aplastic anemia. The guidance notes scenarios when use of animal studies can be reduced by eliminating or delaying certain nonclinical studies.

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Medical Device Development Tools Qualification Program

The FDA Center for Devices and Radiological Health is continuing to expand acceptance of alternative information and non-animal testing to support biocompatibility evaluations of medical devices. The Center’s guidance on Qualification of Medical Device Development Tools explains how new tools can be developed and qualified for a specific context of use, so that qualified tools can be used to support regulatory submissions to the Center. The policy outlined in the guidance is applicable to in vitro models to replace animal testing where appropriate. Slides, an audio presentation, and a transcript of a webinar presented to answer questions on the guidance can be found on the FDA website. To date, biocompatibility or toxicology tools have not yet been qualified under the Center’s Medical Device Development Tool program. Once qualified, these tools will be published in the Medical Devices section of the FDA website.

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