By Katie Booth
The FDA Law Blog has just published a semi-serious study by Kurt Karst on the growth of Title 21 of the United States Code (“USC”) compared to Title 21 of the Code of Federal Regulations (“CFR”) over the past twelve years. Title 21 governs food and drug law. Karst used the PDFs of the USC and CFR available on the Government Printing Office website to compare the number of pages in the USC and CFR from year-to-year. A graph of his results is available on Karst’s post, “The Obesity Epidemic: FDA’s Growing Waistline!”
Unsurprisingly, Title 21 of both the USC and the CFR grew in length between 1999 and 2011. More interestingly, however, the USC grew by 50% while the CFR grew by only 10%. If the purpose of regulations is to interpret and flesh out statutes, common sense would suggest that food and drug regulations would grow at a greater rate than food and drug laws (or at least at the same rate). Karst’s explanation for his findings is that the “FDA has been issuing far fewer regulations, and instead, has been implementing the law through guidance and other policy documents.”
There may be something to this. Issuing regulations can be time intensive and costly. It makes sense that the FDA might prefer to achieve the same result through less formal means. A similar study of the balance between statutes and regulations in another section of the USC, such as OSHA, might provide insight into whether this phenomenon is confined to FDA law.
If the FDA is issuing guidance instead of promulgating regulations in some areas, a further question is whether this matters. The FDA’s standard disclaimer on its guidance documents states that the documents “do not establish legally enforceable responsibilities” but only “describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.” This disclaimer suggests that guidance documents have less weight than regulations, at least in some circumstances. Whether companies treat guidance and regulations differently in practice is another question.
At the same time, publishing guidance isn’t a cakewalk. It’s possible that the FDA is promulgating fewer regulations and issuing less guidance than we might expect given the growth in the USC. Either way, Karst’s study raises a number of interesting questions that deserve further study.
Katie: stimulating post and study. I think it’s worthwhile to consider the focus on non-binding guidance through the lens that Marcia Angell provides (most recently in her series of articles in The New York Review of Books), where she describes FDA officials who refer to industry as “clients” rather than as regulated entities. In my experience working and speaking with in-house counsel at life sciences companies, FDA guidance is followed only insofar as it serves the interests of the company. Regulatory capture at its finest?
I don’t know – maybe it’s a little dated now, but in my experience in private practice representing pharma companies, they definitely felt and perceived that the agency treated guidance (and even drafts) as binding, disclaimers or not.