FDA is open to replacing animals with “organs-on-a-chip” for drug testing

This week’s issue of The Economist featured an article called “Towards a-body-on-a-chip.” The article discusses advances in nanobiotechnology that enable the creation of "organs-on-a-chip" that use a combination of live cells and micro-engineering to create bio-simulacra of individual human organs suitable for drug and other experimental tests, including ones that could not safely or ethically be done with human subjects. The article broaches the topic of linking these "organs-on-a-chip" to create a "body-on-a-chip" or a "patient-on-a-chip," which could be used to pre-test proposed therapies for an individual without putting him or her at personal risk.

The article concludes by saying:  “Yet as the technology improves and becomes better understood, conservative regulators should gain enough confidence in the new technology to start replacing some mandatory animal testing with organ chips.”

So I tracked down the appropriate official at the U.S. Food and Drug Administration (FDA) and asked for a comment.  Here’s what they had to say:

“The FDA would accept such test results (from ‘organ on a chip’ testing). However, while these test results may provide some useful information about a drug, these results alone would be insufficient to support the use of a drug in clinical trials or a drug’s approval without other testing.

“Various alternative methods, including testing that involves the use of ‘organ on a chip’ technologies are currently being used to screen compounds by some researchers and drug developers. The requirement for animal testing could be eliminated when it is demonstrated that these alternative methods can provide the same information as animal testing with an acceptable degree of confidence.

“FDA is actively engaged with NIH in supporting advances in the science in this challenging area. We look forward to the time when this technology (‘organ on a chip’) allows us to use it in place of other forms of testing and until then we believe it can provide information that is useful in addition to information that is currently required to be submitted.”

By saying that, “The requirement for animal testing could be eliminated when it is demonstrated that these alternative methods can provide the same information as animal testing with an acceptable degree of confidence,” the FDA is opening the door to the widespread use of this new technology.

It seems that things are going the way The Economist suggested and that FDA, however conservative it might be, is sufficiently confident to be open to new ways of doing things.