People in Every Walk of Article Critique

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Instead, the research shows that the faster pace of the review process was due to where financial resources went -- to FDA staffing -- not where it came from. The more funding for review scientists there is, the more scientists are on staff, and more work gets completed at a faster rate. The study found that the decrease in turnover time from application submission to completed review began a few years before the passage of the Prescription Drug User Fee Act, thus before the collection of those user fees started (Carpenter et al., 2003).

The question for us to consider is whether the increased efficiency observed by Carpenter et al. means that the FDA is moving back toward a Type I error orientation from the Type II orientation observed by Miller et al. Viewing the drug review process along the dimension of rate of review alone might suggest that a Type I error orientation is taking hold again in the agency. Drugs are being approved faster, suggesting less examination for potentially harmful side effects.

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However, if the number of qualified review scientists is increasing due to greater resources being put toward staffing, then there is an increase along the manpower/man-hour dimension to take into consideration. Increased manpower results in higher man-hours of work per unit of time, meaning more evaluation and analysis is taking place because more workers are employed to handle these tasks.

The exact answer would depend on just how the workload is distributed among the staff. If there are more scientists handling more reviews, thus speeding up the process for each review, then the error orientation has shifted toward Type I. On the other hand, if the staff were used in a manner that performs multiple analyses of the same drug concurrently, then there would still remain a Type II error orientation, yet now achieved with a smaller investment of time. From a consumer's perspective, one would prefer the latter scenario......

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