Today’s WSJ carries a story about the mysteries of the FDA’s process for approving new drug names.
The FDA’s scrutiny, an odd corner of the federal bureaucracy where language meets safety, is a growing problem for drug companies. They spend as much as $1 million per product making up, checking and registering words like Lipitor, Prozac and Zyprexa. In the 2004 fiscal year, the agency’s name-safety reviewers turned down 123, or 36%, of the proposed names they received. That was up from 90, or 29%, the year before, and 86, or 31%, in 2002. The rejection rate now may be even higher. The FDA recently toughened its procedure by requiring that possible names be checked against overseas brands because of concerns about U.S. drugs that have names identical to some used abroad, but very different uses.
To find out whether a drug works, a manufacturer runs studies, with the guidance of the FDA. The agency then decides whether the product merits approval. With a proposed name, the agency does its own internal tests to see whether the name is likely to be confused with that of an existing drug. The tests involve writing the names on mock prescriptions to check how they would look in real-world conditions, conducting Web searches and using a proprietary software program that the agency has never released.
Since I’m teaching trademark law this Spring, this strikes a “trademark” kind of chord with me, rather than a “property” kind of chord. The question is: What kinds of naming rules do we have out there, and does the variety of naming rules tell us anything interesting and useful about which naming rules are used when? I want to leave the answer to that question open-ended (there’s a law review article topic, if anyone wants it). Here are the items that prompt me to think about the question:
Naming regimes are “public” and “private,” and marketized and non-marketized, to different degrees.
There are, of course, public trademark regimes around the world. There are related legal regimes, which operate adjacent to trademark law: There is “right of publicity” and “right of privacy” law, and the First Amendment in the United States, and for pharmaceuticals, FDA review of new drug names. Trademarks and publicity rights and even drug names can be bought and sold and licensed, but only under certain circumstances, and sometimes only with government approval.
There are purely private regimes for names: Under many circumstances, you can choose your own name, without any government blessing. The rules of the Screen Actors Guild prevent SAG members from acting under names that are confusingly similar to one another. By and large, thought publicity rights allow you to license your name, you can’t sell it or exchange it outright.
And there are mixed regimes — partly private and partly public — such as the domain name system, where creation of the name and protection from appropriation is semi-private, and there is a thriving market in names.
As I noted above, a little bit of the “virtual property” scholarship has touched on this theme. Perhaps we shouldn’t think of these as “exclusion” and “ownership” issues. Are these cognitive problems? Consumer protection problems? Goodwill problems? This project, if someone turns it into a project, is a something along the lines of Vic Fleischer’s “explain the anomaly.” Would a rose, by any other name, smell as sweet?