In January, President Obama issued an executive order demanding that government agencies, including FDA, submit a plan for reviewing existing regulations. Their aim, he said, should be to examine rules that could be outmoded, ineffective, insufficient or excessively burdensome, and to "modify, streamline, expand or repeal" them based on accumulated knowledge.
According to an article in Government Executive magazine, over 132,000-plus government rules have passed over the last 30 years, and 1,200 of them have an impact of more than $100 million each. Another 43 major regulations became final last year, and their potential cost could exceed $2.65 billion, according to the Heritage Foundation .
The order will, according to reporting by various news sources, require each agency to:
(1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify);
(2) tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations;
(3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt;
As consultant and PAT expert Ken Leiper notes, this could be bad news for QP's, or "Qualified Persons", whom he defines (as Emil Ciurczak does the GMP priesthood) as "those who have acquired a divine right to release batches of pharma product to the market. "
But now the question: Which ones should go? Any votes? And what could all this mean for the drug industry?
AMS
