Risk Assessment and the FDA

The March 1, 2006 issue of Genetic Engineering News features a column by Shep Bentley under the heading of FDA News & Analysis titled:  Finding a Balance in Assessment of Risk. The essential question impacting the drug industry is who should decide when a product is unsafe, and by what standards ?  The most critical problem appears to be the absence of  any remotely standardized expression of benefit within the paradigm of risk/benefit analysis. Value ascribed to  a drug or a process may be vaguely inferred, but rarely clearly stated and quantified.

This "biomedical" analysis differs from risk assessment involving toxicological and analytical chemistries, although both are forced to address inherent uncertainties. In the latter, the ever lower threshold of instrumental detection limits has often left uncertainty factors to the imagination (and potential manipulation) of the beholder.  In the medical realm, the "First Do No Harm" principle runs the risk of being extrapolated into a precautionary principle that may  preclude the accommodation of reasonable (calculated) risk.

Probably under-appreciated is the reality that the common denominator for evaluating risk is society's values. A pain-averse society uses a quality of life measurement that teeters on a delicate balance of function and comfort. Pre-market drug submission that includes less risk-related data and more quantitative expression of product benefit would be the new paradigm. But the fact is that although risk mitigation is a zero-sum exercise, there is always some residual risk.

More information can be found at www.genengnews.com.