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FDA Begins Qualifying Non-Animal Testing Options

Lab mouse

(tiburi, Pixabay)

4 Dec. 2020. The Food and Drug Administration began a pilot program for assessing alternative technologies to test drugs, biologics, and devices without animals. The Innovative Science and Technology Approaches for New Drugs or Istand initiative, announced on 30 Nov., plans to evaluate a few of these non-animal testing technologies each year to determine their feasibility and public health impact.

Istand is part of FDA’s drug development tool qualification program that authorizes testing methods for new drugs, biologics, and medical devices. Those tools today include animal models, molecular indicators called biomarkers, and reviews of clinical outcomes. Testing methods falling outside these three categories were previously considered on a case-by-case basis by FDA as part of its review new medical products.

Istand offers a way for drug makers, biotechnology companies, and health technology developers to propose these alternative testing methods on their own. FDA anticipates reviewing techniques such as artificial intelligence algorithms to design clinical studies or evaluate patients for trials, clinical outcome evidence from remote telemedicine sessions, digital photo evidence of dermatology treatments, microfluidic tissue chip devices that test for safety or efficacy, non-clinical pharmacology or toxicity tests, and sensors for measuring adherence to prescribed treatments.

FDA lays out a three-step process for qualifying new testing technologies that mirrors the same process employed for currently authorized techniques. A letter of intent outlines the proposed need, Istand applicability, drug or device development context, technical description, and any previous interactions with FDA or other regulators. If FDA accepts the letter of intent, developers may proceed to a qualification plan, and with FDA acceptance, a full qualification package. FDA also provides an alternative review pathway — such as meetings with FDA staff, white paper, or new FDA guidance — if the technology does not fit into the main three-step qualification process.

So far this year, drug and device developers and regulators signaled a growing acceptance of these techniques. A paper published in the journal ALTEX – Alternatives to animal experimentation in July 2020 spells out the case for microfluidic, or lab-on-a-chip, devices as reasonable alternatives to animals for testing new drugs and medical devices. The paper also identifies challenges to adopting these techniques, namely lack of evidence qualifying these devices in specific contexts and communication gaps among stakeholders.

The paper’s 46 authors include representatives from academia, drug makers, consumer product manufacturers, and stakeholder groups worldwide, as well as FDA. A paper published in April authored by FDA staff in the journal Regulatory Toxicology and Pharmacology indicated the agency’s openness to new non-clinical technologies for assessing drugs and devices.

The Physicians Committee for Responsible Medicine, a Washington, D.C. advocacy group, lobbied for a program like Istand for at least five years. Elizabeth Baker, the group’s pharmaceutical policy program director, and one of the ALTEX paper co-authors, calls Istand a “monumental step” in a Physicians Committee statement. “Istand provides a much-needed avenue,” notes Baker, “for the FDA and industry to integrate new approaches that will improve drug development outcomes for humans without harming animals.”

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