Generalization, safety research results

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

For two decades, the Ethyl Corporation had controlled the worldwide market for the tetraethyl lead additive discovered by Thomas Midgley, Jr. (Chapter 6). Ethyl s 2 million annual advertising budget identified tetraethyl lead with baseball, football, and the American Way of Life. The company funded almost all the research about tetraethyl lead s effect on human health. As a result, research on tetraethyl lead had focused on safety in the factory workplace rather than on the health of the general population. 

Focus of the development process for a new pharmaceutical is an essential aspect of success, but is also difficult to maintain. Clinical research units generally desire to pursue as many or as broad claims as possible for a new agent, and frequently also apply pressure for the development of multiple forms for administration by different routes. These forces must be resisted because they vastly increase the work involved in safety assessment, and they may also produce results (in one route) that cloud evaluation [and impede Institutional Review Board (IRB) and regulatory approval] of the route of main interest. 

The publication of the results of clinical trials and preclinical research has resulted in the general understanding that biopharmaceuticals can be toxic as well as beneficial in humans and animals and that many aspects of their toxicity can be studied with relevance in animals. Toxicology as a science has benefited from this experience in many ways by improved and widely applicable understanding of basic biological mechanisms of health and disease and the introduction of novel methods to detect and assess effects. Case-by-case assessment based on science encourages scientific advancement in toxicology and infuses excitement and quality research into safety assessment. 

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