Comment from Joy Laufle
AnonymousSupportIndividual
Summary: The commenter supports the guidance by advocating for the reduction of animal testing in favor of a "Weight of Evidence" approach. They request that the FDA clarify what constitutes a strong evidence package, promote consistent review, and reduce barriers to using existing scientific data.
In development of a new drug or treatment, there are currently two ways to answer important safety questions.
Option 1: Conduct another animal study. According to the NIH, more than 90% of drugs tested on animals successfully translate to human trials and this has been the case for decades. So this method seems outdated, pointless, needlessly cruel, and a waste of taxpayer money.
OR
Option 2: Submit a strong Weight of Evidence (WoE) package that brings together all of the available scientific evidence to show another animal study isn’t necessary.
If FDA accepts that evidence…
…those animals’ lives are spared.
I am writing today to ask you to do the following:
- clarify what a strong Weight of Evidence package looks like
- measure whether this guidance is making a difference and publicly report this information
- promote consistent review.
- help sponsors strengthen the evidence.
- reduce barriers to using existing evidence.