Good Reprint Practices

According to the Gray Sheet (January 19), Henry Waxman has called for re-examination by the Obama administration of FDA’s Good Reprint Practices guidance document. Its no surprise to hear the congressman’s reaction. You’ll recall that he expressed very public objections to the draft version of this Guidance when it was leaked before being published by FDA last year (actually I think the leak happened in 2007). Waxman has been critical not only of the idea of the policy itself, but also of the way in which it came to be in the first place. Further, the Guidance document has been held up as an example of “midnight regulations,” those regulations (or in this case guidance) that are finalized or enacted by an outgoing administration just prior to the changing of the guard (hence the term “midnight”).

For my part, I can’t comment on any of the procedural issues related to the drafting or finalization of this guidance document. I wasn’t involved, wasn’t asked to be involved, and likely won’t be asked to be involved in anything in the future. But, that won’t stop me from doing my own “re-examination.”

Over the coming days (or weeks perhaps depending on how busy I am), I will provide a part-by-part examination of this guidance document (starting with the first part, of course, and ending with the last part). Just so you know, I don’t have all that much of a problem with this guidance document (see my other posts). Nonetheless, the guidance document doesn’t necessarily represent what I would have written (if I were king). On the other hand, going in I am of the perspective that the plain language and meaning of the document (and of the relevant laws and regulations) is not the golden fleecing some have made it out to be, and it retains for FDA significant authority to enforce against bad behavior. Maybe the exercise will give me some epiphany. I doubt it, but we’ll see.

Yours truly,

John

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