Good Reprint Practices

Why the FDA did what they did?

As a former Regulatory Review Officer at FDA (DDMAC), I wanted to offer my thoughts on why the FDA drafted and finalized the Good Reprint Practices guidance document. The answer can be summed up with the following analogous short story:

Once upon a time, in a land pretty far away (for me anyhow), out West to be sure and during a time of rapid expansion of the US population to this territory, we had plenty of lawless activity going on with very little oversight and enforcement of the same. In today’s terms, it would be like driving on a road without a speed limit every day, all day. The problem with the great West expansion is that the “Law” couldn’t keep up with the criminals and the criminals seem to pay no mind to the law. In today’s terms, it is like having 30 people speeding on a highway (with a posted speed limit) with only 1 police officer to pull them over.

Herein lies the problem, the FDA was in a serious predicament. For just about 10 years (1997-2007), we were in a period of grave uncertainty in terms of what to do about reprints. In other words, no speed limit really, at least on the highway. Of course we had those who would choose a more direct and definitely safer route who traveled on country roads through small towns and those are the same folks that followed Section 401 to a T. Let’s just say the FDA really liked these people for complying with what was clearly a voluntary process for the pre-review of reprints prior to dissemination. They had their say in what the companies were doing and this made them happy. Let’s not forget about the small fee (not so small actually) attached to filing of an sNDA (for the use that was the subject of the reprint) that was mandatory under the elective FDAMA safe harbor.

For those still traveling on the highway and in some cases, at high rates of speed, the FDA was seemingly powerless to act. Not only were there too many speeders on the road, the FDA’s police car had a dead battery (courtesy of the WLF court cases) and could only refer cases to other entities, maybe like a cop in the next town, or the DOJ. While many companies took a pseudo FDAMA-like approach (by disclosing the off-label use and adding a couple of other disclaimers), they did not, in large part, do so under the guidance or pre-review of the FDA. In all honesty, a good majority of companies had sound internal review processes in place and disseminated only those reprints that met certain standards –the same standards that they hoped would be amenable to the FDA. They were not concerned about the police officer on the side of the road and did not care whether or not they had a dead battery. They were, afterall, confident that they were complying with the law. Others though, fell prey to the lure of whiskey and fast times in a seemingly lawless world. They slapped a cover page on a reprint, no matter where it was published and what it said about their drug, and “let it ride.” These are the same folks whose reprints were probably not the only thing that was being improperly disseminated and succumb perhaps to a subpoena, an investigation, or even a settlement for off-label promotion, and the reprint(s) were just another piece of evidence.

Under FDAMA and now under the Good Reprint Practices guidance document, the FDA has more of a say in the matter – with the new guidance document, they are setting a speed limit and letting you know that they have the staff, the police cars, and their batteries charged ready to pounce. For the lawless individuals out there, it provides notice – something that wasn’t readily apparent before. For WLF fans and fans of the First amendment in general, it says, we hear you and we heard the judge, and here is our response. The new guidance document is not an over-reaching abuse of power or intended to be an encroachment on the freedoms we sometimes take for granted, but it is to be sure, a rectangular document that is white with black lettering (much like a speed limit sign) that sets some boundaries on what could otherwise be a really tragic situation if left alone to the good judgment and morality of the masses. The guidance document was not intended for the 99% (completely fabricated) of folks who are lawful but the 1% who want to create their own laws or ignore the ones starring them in the face. The FDA needed to act to set forth some clear standards (we will discuss this on another day) and bring power back to where they believe it belongs. They did so, miraculously, in short order on the heels of an expiration of a political administration. I’ll let John do the political analysis and blogging on this coincidence and what seems as if it is the shortest time from start to finish for a guidance document to make it through the system. John is more adept at these political matters than I am. For me, I will be commenting on the good, the bad, and the ugly with the new guidance document in the weeks to come. For now, I hope you enjoyed the story and understand why the FDA did what they did.

M. Misocky

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