Legal responsibilities of the pathologist

Pharmaceutical companies exist today in a hostile legal and regulatory environment. The threat of product liability in the pharmaceutical industry has risen to the point where it stifles research and development, especially for contraceptive and psychotropic drugs. Regulatory sanctions against the industry are more likely now than in the past since the Food and Drug Administration (FDA) has placed significant emphasis on regulatory inspection and enforcement. Industrial pathologists play a critical role in defending their company in product liability litigation and from regulatory sanctions. In-house and contract pathologists should be prepared to give expert testimony in court and ensure that an effective document retention policy is implemented. Pathologists should know the limits of the FDA's inspection authority and be aware of the "pitfalls" of the FDA's new Fraud Policy. In addition to keeping abreast of science, industrial pathologists today can best serve the pharmaceutical industry if they maintain an awareness of legal issues that pose a threat to the future success of the industry.