When I started reading Kurt Karst’s blog post entitled “Code Orange – The Orange Book Archives Have Arrived” this morning (here), I thought, well, the FDA must have developed an archive of all of the old Orange Books (OB) and Kurt is announcing FDA’s good deed? Wrongo, beaver breath! It was Kurt and the folks at Hyman, Phelps and McNamara that undertook a labor of love and scanned every edition of the OB and its supplements (save a few they could not locate) and put them on their firm’s webpage!
The best part about this massive undertaking is that the entire dataset is searchable. I cannot tell you the number of times I have had to flip through back issues of the OB to research an issue on older products, patent and exclusivity issues, changes to the preface, and on and on. There were times I had 4 or 5 different editions open at one time trying to compare sections or see where and when a change was made. I stopped ordering the hard copy of the OB from the US Government Printing Office in 2013, the year after I retired from full-time work at Lachman and I miss not having the last 8 years’ editions.
Every time my wife comes into my office, she says “when can we get rid of these things, they take up too much room!” Well, the answer is now – but I am sure it will take a few years before I can even begin to overcome the thought of discarding them and my separation anxiety will be like a remake of “High Anxiety” by Mel Brooks.
So, for those of you who are Hatch-Waxman junkies, or for those of you who just love the OB, its history is now in a single location on the internet and can be accessed by anyone, as a public service from Kurt and his OB team at his law firm, with just a click of your mouse!
