IN 1952, and again in 1979, errors made by a manufacturer led to the sale of infant formula that lacked an essential nutrient. Since formulas are often infants' sole source of nutrition, and because babies' bodies and nervous systems develop so rapidly during the first few months of life, missing nutrients can have tragic effects, including, in these two cases, convulsions, growth impairment, mental retardation and cerebral palsy.
Prompted by the second incident, Congress passed a law requiring manufacturers to test every batch of formula before shipping, and tightening up the Food and Drug Administration's recall requirements so that the confusion, delay and ineffectiveness that marked the Syntex formula recall would not be repeated. That was 18 months ago.
While parts of the executive branch debated the wording, the "intrusiveness" and the necessity of FDA's proposed regulations to put these requirements into effect, and while the regulators at FDA struggled to fulfill the requirements of the Regulatory Flexibility Act, the Paper Work Reduction Act and the President's new Executive Order on Regulatory Relief, it happened again. In an eerie repetition of the 1952 blunder, the same manufacturer, Wyeth, left out the same ingredient, Vitamin B6. This time, an employee had dumped Vitamin B1 into the B6 container.
Regulatory "relief" (the administration) or "reform" (the Congress), is currently the rage in Washington. The infant formula debacle is a timely reminder that this endeavor can have some limitations and risks of its own. There is, first of all, the problem of delay. The flood of reforms that began in the Carter administration--and which now includes beside those listed above, the Vice President's Task Force on Regulatory Relief and the Regulatory Reform Act currently being considered by Congress--delays urgent regulations along with the trivial.
Only painful experience, it seems, will cure the current infatuation with cost-benefit analysis. While such analysis can be a useful regulatory tool in a limited way, it is not a magic decision-making wand. Debates over regulations, especially if they affect health and safety, appear to be about costs, what the scientific data show and other facts amenable to objective analysis. But what they are usually about are subjective judgments: How safe is safe? Which costs should be part of the price of doing business? What should be done when the facts are uncertain?
The right way to regulate depends on what is being regulated. In the infant formula case, for instance, the manufacturers complained about the specificity of the mandatory testing requirements, but wanted their recall obligations spelled out in minutest detail, down to the last required phone call.
Finally, there is the administration's generally preferred option: voluntarism. More trust between government and business is a fine thing--in its place. But regulations that affect public health and safety aren't that place.