FDA Law: More Statutes Than Regulations?

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.

kbooth

kbooth

Katie Booth Wellington was a Student Fellow during the 2012-2013 academic year. At the conclusion of her fellowship, she was a third-year law student at Harvard Law School with a focus on health care law. She attended Yale University, where she majored in English. Prior to law school, Katie worked for two years as a management consultant for pharmaceutical, biotech, and agribusiness companies. Katie was the joint Editor-in-Chief of the Harvard Journal of Law and Technology, which focuses on intellectual property law, health law, and technology law issues. During law school, Katie interned in the Health Care Fraud Unit of the United States Attorney’s Office in Boston and in the Health Care Group at Ropes & Gray. During her fellowship, Katie researched the problem of cyberattacks on wireless medical devices, focusing on the current U.S. legal and regulatory structure.

0 thoughts to “FDA Law: More Statutes Than Regulations?”

  1. 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?

  2. 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.

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