One of my absolute favorite things about being a law professor is helping students who are writing articles for publication. I don’t mean student notes — working with students writing notes can be fun, but isn’t always, both because the form is very Procrustean and because some of the people who write notes here are just doing it to make Law Review, and don’t intend to make the extra effort needed to have their work published. I mean the students who write a full-scale article. Doing a publishable article is scads more work than doing a regular paper, and usually involves several additional drafts. Most students just don’t have the time or interest. But I get a few who do, maybe one or two a year, and working with them is a particular joy.
Thus, I’m especially pleased to announce that Christine M. Humphrey, a December 2003 graduate of UM Law, has just published her article The Food and Drug Administration’s Import Alerts Appear to be “Misbranded”, 58 Food & Drug L.J. 595 (2003). The FDLI does not put full-text online, but you can expect an online abstracts for 58:4 Real Soon Now, and Ms. Humphrey informs me that her firm will be hosting the text soon (I’ll update this item when it does). Meanwhile, if you have access to Westlaw, you can view the full Westlaw version. Ms. Humphrey did the work on the article while a student here — and a lot of work it was, too as I think she did more than half a dozen drafts for me, at least two after she’d already received her final grade. (The Buckley Amendment does not Allow me to Announce her grAde.)
Although the subject is a little specialized, the article is important. It argues, I think very persuasively, that the FDA is illegally circumventing the Administrative Procedures Act (APA) to issue “Import Alerts” — decisions that effectively bar the importation of whole classes of products but that the agency says are merely “guidance” documents. The article juggles the intricacies of the FDA regulations and the complex underlying APA rules and shows how they are in tension. The issue is sure to be litigated soon unless the FDA cleans up its act.