The goal of every pharmaceutical company is to get a product to market. Therefore, it is reasonable to expect that Martex would be excited to get their antibody, Baluride, to this stage. The legal team and upper management want to safeguard their product. Validation of a new test may mean one thing to one agency and something different to another. Upper management would have justifiable concerns that satisfying a requirement of one agency could put them in jeopardy with another agency.

Everyone wants alternatives to animal testing, and there are several good reasons for this. The most obvious reason is the humane concern for the animal. But time and cost are also considerations. In vitro tests can be less expensive and less time consuming than using live animals. So there are compelling reasons, at all levels, to replace the use of live animals with the LAL test as soon as possible.

The IACUC erred when it accepted the judgment of upper management without question. It is the responsibility of the Martex IACUC to review the use of animals according to USDA regulations which state that “[p]roposed activities and proposed significant changes in ongoing activities that have been approved by the IACUC may be subject to further appropriate review and approval by officials of the research facility. However, those officials may not approve an activity involving the care and use of animals if it has not been approved by the IACUC1.” The IACUC should have reviewed these protocols without consideration for the decisions of upper management.

With appropriate justification the IACUC could approve the use of rabbits for pyrogen testing while the alternative test is being used in parallel. The scientific/technical justification and regulatory concerns should be clarified in detail in the protocol application. Scientists submitting the protocol could request parallel testing until they are satisfied that there are no scientific/technical problems with the alternative test, and that it will be accepted by all regulatory agencies.