To approve or not to approve? That is the question. Ethical concerns over the regulation of immunohistochemical stains.

Over the past two decades, immunohistochemical stains have evolved to become an essential part of the practice of surgical pathology. An extensive literature documents significant diagnostic and prognostic applications, and the pathology journals add new applications and new tests almost on a daily basis. The antibodies that provide the basis of immunohistochemical stains fall under the purview of the Food and Drug Administration (FDA). The vast majority of these antibodies have not been submitted for FDA approval or clearance, but nonetheless are widely employed in practice. The FDA, therefore, faces a major dilemma in attempting to fulfill its legislative mandate. Lack of adequate regulation may permit the use of unproven or poor quality reagents. On the other hand, overzealous regulation will preclude the use of large numbers of stains that are now integral to the diagnostic process. If ethical considerations truly are governed by following the course that leads to the greatest good for the greatest number, then the evidence suggests that overzealous regulation should be avoided. The argument is presented that immunohistochemical stains should be treated no differently from other special stains already in use in surgical pathology. With all tissue stains, including immunohistochemical stains, the pathologist makes the diagnosis by interpreting morphologic features and staining patterns: the stain alone is of no value to clinician or patient, rather it is the pathologist's report that establishes the diagnosis. It is suggested that a certification process that ensures quality and technical validity, somewhat analogous to that already in existence for biological stains, would be sufficient to meet the needs of the pathologist, providing ongoing benefits to patient care, with minimal risk.