Green Cross Corporation
Gaining Food and Drug Administration approval on a potential drug is a long and arduous process in which a company must abide by numerous regulations. When the company is publicly traded, complexities ratchet up a notch. When it is also not U.S.-based but has investors here, the situation becomes more challenging. And when the product in question is an artificial blood, well, that is a whole different story. Tokyo-based Green Cross Corporation’s Fluosol-DA fulfilled some functions of biological blood and provided an alternative to transfusion, which helped avoid risks of disease transmission, as well as address the donor shortage and concerns of Jehovah’s Witnesses and religious objections to receiving transfused blood. Because of numerous hot buttons surrounding the topic in general and the anticipation surrounding Fluosol, we had to walk a fine line between communicating the potential of Fluosol and maintaining strict adherence to FDA guidelines. We also had to meter speculative reporting on its financial impact while also acting as company spokespeople to the media and individual investors. Our work paid off: Fluosol-DA was the first oxygen-carrying blood substitute approved by the FDA and remains the only oxygen therapeutic ever fully approved by that organization.