Posted: 20 Feb 2020 10:55 PM PST
By Deborah L. Livornese —
Blog readers may be thinking, “HPM, didn’t you just blog about the Vanda case last week?” We certainly did (and had previously here and here). You will recall that Vanda Pharmaceuticals did not prevail in its quest to have the Court find that FDA’s imposition of a clinical hold due to requirements for certain dog studies that would require euthanizing the dogs was arbitrary and capricious. We have learned, however, that the company has not dropped its pursuit of change in the use of animals in preclinical studies.
In a January 23, 2020 letter to Dr. Janet Woodcock, the Center Director of the Center of Drug Evaluation and Research, and Dr. Peter Stein, Director of the Office of New Drugs, Vanda discusses not the particulars of the drug that was subject to the litigated clinical hold, but the broader need to identify and adopt better predictive technologies in the area of toxicology.
In addition to suggesting a private-public partnership to look at the adoption of such technologies, Vanda describes two technologies stating that they are adequately validated in reproducibility and predictive power for liver injury.
We have heard FDA recognize the need for and voice the desire to see ways to conduct necessary preclinical toxicologic evaluations while minimizing the need for animal studies or reduce the need to euthanize animals used in testing. Among the challenges to this shift is the need to validate proposed new approaches to preclinical testing. In 2018, then Commissioner Gottleib announced a proposed FDA study to evaluate alternative methods for evaluating certain locally acting, nonsystemically absorbed drugs in dogs in an effort to develop a model that could be used in place of testing in dogs in the future. It was also proposed that the dogs used in testing would not be euthanized at the end of testing, but would be adopted. FDA issued a White Paper and solicited input on the proposed study.
The challenges in transitioning from traditional animal studies to modeling or other alternative methods for assessing risk prior to first use in humans are real. In particular, the validation of some alternative methods has been hampered by the need to do lengthy trials or a lack of clarity about what acceptable validation data look like. Industry, the FDA and other experts working together should be able to move forward to realize the goal of eliminating or reducing the use of animals. Vanda’s letter may (re)ignite these efforts and lead to a private-public partnership, or it may shine a light on existing efforts within the Agency that may not be well-publicized. The dog-lovers among us hope so.
We should note that FDA has made some strides in reducing euthanasia of animals used in its own labs. In November of last year, FDA adopted a new policy for its research animals. Under this policy, FDA “supports the transfer, adoption or retirement of FDA-owned research study animals that have completed their assigned research study” and that meet certain criteria related to health and behavior. FDA’s policy leaves it to individual programs to establish specific procedures for the placement of the animals.
Blog readers may be thinking, “HPM, didn’t you just blog about the Vanda case last week?” We certainly did (and had previously here and here). You will recall that Vanda Pharmaceuticals did not prevail in its quest to have the Court find that FDA’s imposition of a clinical hold due to requirements for certain dog studies that would require euthanizing the dogs was arbitrary and capricious. We have learned, however, that the company has not dropped its pursuit of change in the use of animals in preclinical studies.
In a January 23, 2020 letter to Dr. Janet Woodcock, the Center Director of the Center of Drug Evaluation and Research, and Dr. Peter Stein, Director of the Office of New Drugs, Vanda discusses not the particulars of the drug that was subject to the litigated clinical hold, but the broader need to identify and adopt better predictive technologies in the area of toxicology.
In addition to suggesting a private-public partnership to look at the adoption of such technologies, Vanda describes two technologies stating that they are adequately validated in reproducibility and predictive power for liver injury.
We have heard FDA recognize the need for and voice the desire to see ways to conduct necessary preclinical toxicologic evaluations while minimizing the need for animal studies or reduce the need to euthanize animals used in testing. Among the challenges to this shift is the need to validate proposed new approaches to preclinical testing. In 2018, then Commissioner Gottleib announced a proposed FDA study to evaluate alternative methods for evaluating certain locally acting, nonsystemically absorbed drugs in dogs in an effort to develop a model that could be used in place of testing in dogs in the future. It was also proposed that the dogs used in testing would not be euthanized at the end of testing, but would be adopted. FDA issued a White Paper and solicited input on the proposed study.
The challenges in transitioning from traditional animal studies to modeling or other alternative methods for assessing risk prior to first use in humans are real. In particular, the validation of some alternative methods has been hampered by the need to do lengthy trials or a lack of clarity about what acceptable validation data look like. Industry, the FDA and other experts working together should be able to move forward to realize the goal of eliminating or reducing the use of animals. Vanda’s letter may (re)ignite these efforts and lead to a private-public partnership, or it may shine a light on existing efforts within the Agency that may not be well-publicized. The dog-lovers among us hope so.
We should note that FDA has made some strides in reducing euthanasia of animals used in its own labs. In November of last year, FDA adopted a new policy for its research animals. Under this policy, FDA “supports the transfer, adoption or retirement of FDA-owned research study animals that have completed their assigned research study” and that meet certain criteria related to health and behavior. FDA’s policy leaves it to individual programs to establish specific procedures for the placement of the animals.
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