Outcome Orientation

A robust regulatory system focuses on product safety outcomes, not on the details of how to arrive at the outcomes. That is not to say that a strong system is not concerned with process. On the contrary, strong regulatory systems often stipulate manufacturing standards and inspection processes. Rather, the outcome-oriented system issues regulations that do not get in the way of innovation. Furthermore, in an outcome-oriented system, industry has a clear avenue to petition the regulatory authority to use alternative processes, and this process is not unduly onerous. An outcome-oriented regulatory agency has the scientific expertise to be abreast of changes in food and medical product technology and the modern equipment to analyze it.

Predictable

The regulatory agency has a clear framework guaranteeing that the regulators’ decisions are neither arbitrary nor capricious. Predictable regulatory systems make their procedures readily available to the public. The rules are applied consistently, enforced fairly, and are based on the best scientific evidence available at the time of the decision. Predictability assumes a level playing field and describes a function in the regulatory system that is vigilant against bias. A fair and predictable system does not work for or against large industry or small industry; regulations are applied the same way to imported and domestic products.

Proportional

A proportional or risk-based system allocates controls based on threat to public health: product lapses with serious health consequences are monitored stringently, while those with few or insignificant risks receive less attention. Products with similar risks are regulated in similar ways. Proportionality depends first and foremost on the ability of the regulatory agency to assess risk. It also assumes that the agency will consider a cost-benefit analysis when measuring the impact of potential risk management options. A proportional regulatory system actively sets priorities ensuring that the agencies’ programs give the most attention to the most pressing public health threats.

Independent

Regulatory policies are the combination of scientific decisions and societal expectations. This is especially true of the system’s legislative oversight. However, once its legal authority is set, the agency functions best when it



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