Nov 20, 2014

It's Not Just You: FDA Regulatory Requirements Really Are Increasing

The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year.

According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.

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.

Regulatory professionals trying to keep up with the increase in regulations would have needed to do a substantial amount of reading during those 13 years as well. Mercatus' data shows that sections of the Code of Federal Regulations dealing with FDA increased a total of 166,892 words between 2000 and 2012—an average increase of 11,920 words per year.

To put the increase into perspective, the 166,892-word increase is longer than J.R.R. Tolkien's "The Hobbit" (95,356 words), Charles Dickens' "Oliver Twist" (155,960 words), and just barely shorter than John Steinbeck's "The Grapes of Wrath" (169,481 words).

However, it is unlikely that any one regulatory professional would need to know every single change made by FDA. Changes to the code reflect requirements for pharmaceuticals, medical devices, biological products, food product, radiological devices and tobacco products. Few, if any, regulatory professionals deal with products in every single FDA-regulated area.

This article is related to the Whitepaper: 21 CFR Part 11 Industry Overview - Ready for an FDA Inspection? To get the full details, please download your free copy

The center's data defines "requirements" as any instance in the US Code of Federal Regulations containing the words "shall", "must", "may not", "prohibited" or "required."

Copyright 2014, Regulatory Affairs Professionals Society's Regulatory Focus. Reprinted with Permission.

Alexander Gaffney is a health policy professional who manages the regulatory intelligence group at RAPS, the leading global association of regulatory affairs professionals. He is also the lead writer for Regulatory Focus, a widely read publication covering the regulation of pharmaceuticals, medical devices, biotechnology products and the US Food and Drug Administration (FDA). 

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