By Kurt R. Karst –
One recent afternoon we returned to our office from a meeting to find the new (2012) nine-volume set of Title 21 of the Code of Federal Regulations (“CFR”) placed on our desk chair. There’s a special place on our desk reserved for the CFR (and the FDC Act) because we use it on a daily (usually hourly) basis. So we replaced the old 2011 CFR set with the new 2012 set. Lo and behold, one bookend moved to the right quite a bit to accommodate the space needed for the new edition – from about 7.5 inches of space to 9.0 inches! Could the CFR have grown 1.5 inches in just a year? Well, it turns out that the paper stock used for the 2012 edition is thicker than the 2011 edition paper stock and that’s primarily what resulted in the need to occupy a greater portion of our scarce desktop real estate. But the experience got us thinking . . . .
How has Title 21 of the CFR – and for that matter, Title 21 of the United States Code – grown over the years? If we were to conduct such a study, it would need to be adequately designed, well-controlled, and minimize bias. In other words, we would need to find a resource that would allow us to compare apples to apples. It turns out that such a resource is readily available. The Government Printing Office website has pdf versions of the CFR that date back to 1996, as well as pdf versions of the United States Code that date back to 1994. And they are similarly formatted so that a good comparison can be done.
So we went ahead with the study and evaluated the year-over-year change in Title 21 of the CFR from 1999-2012 and the year-over-year change in Title 21 of the United States Code from 1994-2011. We did not include the 1996-1998 CFRs in our analysis, because those volumes include Part 400 dealing with insulin and antibiotics, and as a result of changes to the law made by the 1997 FDA Modernization Act, were removed from the CFR beginning with the 1999 edition. Including them would have skewed the results. The 2012 United States Code is not yet available, but as a result of the recent enactment of the FDA Safety and Innovation Act, the FDC Act will once again grow significantly.
We knew before the study that there would be growth in both the CFR and the FDC Act, but the question we did not know the answer to was: How much growth? We were a bit surprised by the results once we put the data in tabular format.
As shown in the tables below, between the period of 1999 and 2012, the CFR grew by a total of 423 pages (10%), although there was a short dieting period between 2003 and 2004. Between the period of 1994 and 2011, the FDC Act grew by a total of 324 pages (84%). While most of the CFR volumes had modest growth, volume 8 (medical devices, mammography, radiological health, and tobacco products) and volume 9 (DEA and ONDCP) experienced the greatest growth in pagination (about 100 pages each) 1999 and 2012. Between 1999 and 2011, which is the shared time period for which we have data, the CFR grew by a total of 398 pages (9.8%) and the FDC Act grew by 238 pages (50%).
What’s odd, of course, is that our study shows that although there has been significant growth in the FDC Act, the CFR, which implements the law, has not kept up. Usually, “if you build it, they will come;” that is, the statutory framework will give rise to a crowd of regulations. But we have a theory for this seemingly odd result: FDA has been issuing far fewer regulations, and instead, has been implementing the law through guidance and other policy documents. Take a look at the list of guidance documents for FDA’s Center for Drug Evaluation and Research alone. Just the list of guidances is 48 pages in length! FDA guidances spanning all centers total hundreds – and probably thousands – of pages. The guidances are not binding like the statute or regulations, but, well, the way they are sometimes applied by FDA makes it seem as though . . . . I think you catch our drift.
Are more laws, regulations, guidances, policies, etc. needed? We’re not making any suggestions one way or the other. But it sure is interesting to watch FDA’s waistline grow as the Agency ages.