Outsourcing-Pharma with Lisa Kramer 19 November 2018
The US Food and Drug Administration (FDA) last week proposed the study that could potentially provide an avenue for animal drug developers to conduct some trials without the use of dogs.
The goal is to conduct a single study to help establish a non-animal based model, said FDA Commissioner Scott Gottlieb explained in a statement.
Though focused on the development of animal drugs, the proposed study is part of the FDA’s broader e orts to reduce reliance on animals used for all types of research.
“While we understand that in certain situations the use of animals in research is needed, we’re committed to exploring ways to help FDA scientists and product developers reduce reliance on this practice,” said Gottlieb, noting that the proposed study is “a big part of that e ort.”
The agency earlier this year established an Animal Welfare Council to oversee all animal research activity. It also has voiced support for the development and use of alternative methods – such as assays and organs-on- a-chip – and has formed working groups for modeling and simulations as well as toxicology.
“As we continue to advance new innovations for animals and people, we’re interested in learning about other new technologies that can reduce, replace and/or re ne the need for animal testing,” said Gottlieb.
Elizabeth Baker, Esq., pharmaceutical policy program director for the Physicians Committee for Responsible Medicine, said such transparent initiatives led by regulators will help replace animal tests “even faster.”
“We applaud the FDA for its transparency in this e ort and request the agency to determine whether new dog testing is truly needed for this study, or whether existing data would allow for validation of this approach,” Baker told us.
If successful, the study will lead to a signi cant reduction in animal use for drug development, said Erin Hill, president of the Institute for In Vitro Sciences (IIVS). “It is imperative that the measurements of success are clearly de ned so that the FDA and industry can gain the most they can from this limited study,” she told us.
In the future, as the industry better understands biological pathways and is better able to model these pathways, Hill said, “we will have the opportunity to protect human health without the need for animals.”
Lisa Kramer, PhD, professor of nance, University of Toronto, told us she would encourage the FDA to “apply more broadly the approach of using species-speci c data to make within-species predictions, with an eye to eradicating the practice of using non-human animal data to make predictions about human responses.”
According to Kramer – who spoke at AAPS PharmSci 360 from a business ethics perspective – it would not be an exaggeration to say that predictive outcomes for humans would improve if decisions about which drugs to advance were made by “ ipping a coin,” rather than using results from non-human animal models.
“Data from one species are simply uninformative overall with respect to other species’ responses, and it’s promising to see this aspect of science incorporated in the FDA’s proposal,” Kramer added.
The FDA is accepting public comment on a white paper outlining the proposed study.