My Note, Bound Guidance: FDA Rulemaking for Off-Label Pharmaceutical Drug Marketing, has recently been published in volume 60 of the Case Western Reserve Law Review, pages 531-558. The Note discusses an FDA guidance document that establishes when pharmaceutical companies can provide doctors with reprints of journal articles promoting off-label uses of their drugs. It considers both the regulatory framework authorizing the FDA’s guidance, and the First Amendment rights triggered by the FDA’s attempt to restrict a company’s commercial speech.
Allowing doctors the freedom to prescribe drugs for a use other than the narrow purpose initially authorized by the FDA can unquestionably save lives. However, it is also essential to ensure that doctors have the information they need to make an informed decision before prescribing a drug for a purpose for which it was not originally intended.
The following interview with Patrick Carman was posted at ARGNet on May 17, 2010.
MA: What lead you to start writing transmedia novels? (Also, is there another term you prefer for the format?)
PC: I’m just going to come right out and say it at the top: Transmedia, as a unifying term, is beyond lame. And it points to a challenge we’re facing in this space: coining a term is a tricky business. What the heck do we call what we’re doing? I tried vBooks (also lame), others have tried Diginovel, iStories, Vook, cross-platform – the list goes on, and I think they all fail to inspire at a level that will bring everyone under one tent. You guys did better with ARG – Alternate Reality Game – it stuck. How’d you do that?
To our credit (and by ‘our’ I mean everyone trying to explode books into the 21st century landscape) we’re talking about a brand new way of telling stories. We’re probably supposed to fumble around in the dark for awhile, but I think we’re getting closer. My two cents as of today is that we’re basically talking about something that’s been around for a long time, namely multimedia. And really, that’s a pretty good term to describe what’s happening to with these books; they’re becoming something broader, encompassing different medias. It’s interesting that movies and TV shows and web sites don’t have the same challenge. Creators of those mediums aren’t sitting around debating what they should call something when a movie has an ARG and spawns a TV show. It’s simply multimedia. The difference with a project like Skeleton Creek or TRACKERS is that I’m committed to a simple premise those other examples aren’t interested in: for me, the destination is always the book. That means the videos, the games, the web sites – they have a job to do, which is to get young readers turning pages. At PC Studio, where we make all these assets, a video is only as good as the pages it pushes a reader to turn.
Long winded already and I haven’t even exited question number one. The short answer is MULTIMEDIA. That’s what it’s called, that’s what it is.