Premarket review and postmarket controls

The first issue to consider is how to develop an approach to pre-market review of new tests that is not unduly burdensome. Pre-market review can have a number of functions. For the most high-risk tests, regulators will use pre-market review to set out in detail the types of clinical studies they require a test developer to perform, as in the FDA's Pre-Market Approval process for Class III tests. Such an approach can require test developers to mount costly clinical trials and delay their entry to the market. There is uncertainty in this process about whether the test developer will be able to provide sufficient data to convince the regulator of the test's safety and effectiveness. For moderate-risk tests, a less burdensome approach to pre-market review can be taken, one which focuses on ensuring truth-in-labeling (as in the FDA's 510 k process for Class II devices). In this model, a more modest amount of data may be required to gain regulatory approval. Indeed, companies will often rely on the existing scientific literature to demonstrate the clinical validity of their tests, rather than mounting studies of their own. The focus here is on ensuring that any claims made for a test's performance are supported by scientific evidence; where there are problems, the regulator can moderate the company's claims rather than requiring them to mount fresh clinical studies.

The burden could further be controlled by limiting pre-market review to appraisal of data on analytic validity (how well the test identifies the gene/s) and clinical validity (the relationship between the gene/s and clinical status). This model would allow companies to reach market fast and to begin to attempt to recoup their investment. At the same time, it allows regulators to fulfill the most pressing obligation placed on them—addressing asymmetries of information by ensuring that companies do not make unsubstantiated and overblown claims for the tests they sell and that they provide test users with accurate and comprehensive information on their tests. However, this approach may allow tests onto the market with only limited evidence of their safety and effectiveness. Even where clinical studies have been mounted prior to market entry, routine clinical use of a new test is the only way to gain a full understanding of its safety and effectiveness. A least burdensome approach to pre-market review should be accompanied by more effective use of post-marketing controls. Similar arguments have been made about the merits of enhancing post-market rather than pre-market controls in drug regulation (Reed et al., 2006).

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