The Lighter Side of Food & Drug LawJuly 30, 2007
Every so often something comes across our desk that is so comical that we feel compelled to share it with others in the food and drug community who will also appreciate it. One such story comes from a case involving Biovail and FDA in the U.S. District Court for the District of Maryland concerning certain Hatch-Waxman issues. The following is an excerpt from the transcript of a December 21, 2006 oral argument before Judge Roger W. Titus in that case. Gerald C. Kell from the Department of Justice argued the case for FDA.
THE COURT: The [Federal Food, Drug, and Cosmetic Act] itself uses the term “strength.” It references the drug with respect to which the certification is made. The certification will mention the listed drug which includes the strength; correct?
MR. KELL: That’s correct, Your Honor.
THE COURT: All right. There’s a special place in Hell where they torture people who write things like this. For 14 years I was on the Rules Committee of Maryland’s Court of Appeals that didn’t have as many subsections as this, so I would flunk the person who gave me this as a draft rule. I would say this is 50 rules.
Anyway, I wanted to wander into the right place of this endless section. When I first went to Westlaw and said, just give me section 355, it had to tell me it was going to be 85 pages. I said, no, no, no, no. Let’s try (j), and I get this huge thing here.
MR. KELL: Well I hope that our brief lays out the precise subsections, Your Honor. I believe it does. But that is the sum of my argument, unless the court has any further questions.
THE COURT: No. You’ve been very helpful. I’m glad to have somebody here who knows what they’re talking about.
MR. KELL: So am I, Your Honor. It’s just not me. Thank you.
THE COURT: Thank you.