Saturday, January 31, 2009


Beyond the Preemption Morass

Apparently, there is interest in the Obama administration in what is called "progressive federalism" - a use of state initiatives as models some of which could lead to federal guidelines which are more just and more rational than the various efforts (through preemption) to canonize gutted regulatory agencies that we have seen in recent years.

In the "progressive federalism" model, federal agencies - FDA, for example - would retain its traditional role as providing foundational standards to which manufacturers must adhere nationally. But there would remain room for states to initiate regulatory models that could serve, eventually, as precursors for what would become federal standards.

Needless to say, this is the obverse of preemption - which would freeze existing regulations in place short of the kind of amendment to FDCA which happens very rarely. Instead, we would have some variation of minimal standards - as, in reality, we already do - out of would grow those worthy of federal mandate.

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  1. Holy crap, nobody in my corner of pharma even cares about preemption anymore. Pfizer/Wyeth getting rid of 26,000 jobs. AstraZeneca, 7400 jobs. GSK, 6000 jobs. And that's only in the last week. It's not just manufacturing. This is getting deep into R&D. As FPME likes to say, I guess there are no "sacred cows" in this economy. The funny (?) thing about all this is that it is largely unrelated to the current economic crisis. Our woes are much more related to the conservative approach at the FDA and other drug approval agencies as well as patent litegation. (generics scooping us before the patent has expired) Of course, some of it is our own fault for having expanded too fast when the times were good. The faster you rise, the harder you fall....

  2. Hi Nathan - Good to "see" you; it's been a while. Yeah, I think about people in industry every time there is another annoucement of job cuts. In Michigan, of course, we've taken the job cut prize (our pharma losses coming earlier)for a while.

    In preparation for a class, I've been rereading that Chem and Engin News article you were once surprised I read at all! It contains a pretty good analysis, I think, and predicted large job cuts as other people did - mostly related to patent expiration and pipeline issues. There is talk of "new business models" but - as for the auto industry - it remains unclear how many are really inclined to go there, and what it really means if they did.

    Anyway, it is the June 19, 2006, issue of CEn, VOL 84:25. Pretty much the whole issue is related to pharma.

  3. Nathan,

    I disagree that it's related to a conservative approach at FDA. You need to look at the data and make a decision based on the data.

    I've actually done that for drugs I've worked on. For example if a drug appears to work in 60 people but placebo works in 40 then it only works in 20 people out of 100. In contrast if the same drug kills 2 people in the first couple of weeks before you can even tell it works then but there's no deaths for placebo then you've got 2 deaths for every 20 people the drug is actually giving benefit. Now if you look at chronic toxicities and you see indications that the drug may maim or kill upwards of 100% of the people on it well I simply don't like those kind of odds, but it's not necessarily my decision alone I would prefer to present the data publicly at an AC meeting and let the public decide if they want it or not.

    In addition, over the years as we learn more about what to look for we learn to weed out the really nasty actors before they hit the market. On the other hand the more desparate companies become when they're facing patent cliffs the more they hide stuff and the more shenanigans you see going on inside of FDA. e.g. coverups, nor forwarding requests for clarifications or data to sponsors, or even threatening and firing the reviewes.

    We need to think outside the box and find someway to continue funding industry so they can come up with those new first in class products. However, covering up safety and selling unsafe drugs off-label for diseases they are ineffective for and infact result in harm which requires treatment is not my idea of what we should be doing.



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