Regulatory process, agencies

But the picture may not be all that bleak, at least from the viewpoint of the individual firm. The very fact that government agencies are usually uninformed about the industries they regulate, that their priorities and procedures for targeting are so ill defined, and that their enforcement processes so arbitrary creates major opportunities for the regulatory process to be influenced to the advantage of the firm. 

The reason for adopting this broad definition of regulation is that any narrower concept (e.g. one limited to legislation and Federal agency rules) is not realistic and would impute more causality to a single government action than is in fact the case. In short, the regulatory process is complex, and should be viewed as such. 

In Europe, the OTC regulatory landscape is still fragmented despite the Mutual Recognition Procedure (MRP) and Directive 921261 EEC (18,19, 45-47). Directive 92/26/EEC intends to provide a uniform framework for the classification of the medicinal products into prescription and non-prescription and facilitates the switch process (46,47). However, its application is left with the regulatory approval agency of the individual country at the time... 

The Chemical Industry Position As this paper has shown, cost-benefit analysis has now been incorporated into the regulatory process of many, though not all, agencies dealing with health, safety and the environment. The American chemical industry is, of course, profoundly affected by those agencies, since their rules deal with its operations, its products, its wastes and its relation to the conmunities in which chemical plants are located. It is therefore worthwhile to examine what the position of the industry is toward cost-benefit analysis in regulatory impact determinations. 

In interviews and informal discussions with company regulatory personnel and clinical researchers, OTA learned that many people involved in the process believe at least some reviewers in ODER use the application not complete notice to manage workloads. These sources claim that ODER staff can always find some additional information is necessary, so the agency can manipulate the starting date of its statutory time limit. To investigate this claim is beyond the scope of the study, but the very existence of this rather widespread belief suggests it is almost impossible to separate out delays in the approval process due to companies inadequate applications from those due to the regulatory process. 

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