Number of FDA’s Regulatory Requirements Increased 15 Percent, 2000-2012
The Regulatory Affairs Professionals Society (RAPS), using data from our friends at the Mercatus Center, have concluded that the Food and Drug Administration’s regulatory requirements have increased 15 percent in just over a decade:
While regulatory professionals working with FDA needed to know just 16,329 requirements in 2000, they needed to know 18,777 in 2012, according to the data.
The analysis uses two measurements of regulatory burden: “Requirements”, defined as any instance in the U.S. Code of Federal Regulations containing the words “shall”, “must”, “may not”, “prohibited” or “required”; and the number of words in the regulations. Both grew at about the same rate.
This is a deadly affliction. The FDA’s overregulation kills people. And the problem is getting worse.
One complaint I’ve heard is that the FDA goes after low hanging fruit rather than basing enforcement on risk. Firms that potentially can harm patients with poor quality have the resources to fight FDA compliance actions. By contrast, small firms that pose little if any health risk often are targets of enforcement.
That would be an interesting thing for us to research.