Saturday, January 21, 2012

Diagnosis: Muddled thinking


An earlier post, 'Help on the way?', had noted that Senator Amy Klobuchar of Minnesota was among the worthy Senators who "... pop up in the news every time a drug shortage occurs and hits the newspapers..." Well, it's either for publicity, to be seen doing something about a national problem, or because she cares about this subject and has developed some sort of expertise regarding this thorny problem...

Her earlier efforts in this regard - S296, the 'Preserving Access to Life-Saving Medications Act' - seemed to this blogger to not be a very useful... For example, the 'advance notification' of planned down times doesn't really address any of the root causes of drug shortages; rather than partnering with manufacturers to develop a multi-faceted approach to addressing the multiple causes of drug shortages, she seems to prefer an adversarial and punitive approach (warning drug companies that they have to do X or face civil monetary penalties, etc. ); etc.

OK, so her efforts perhaps are not because of the former (i.e just leveraging the problem for free publicity), it could just be an early effort/attempt to begin addressing the problem.

However, reading Klobuchar Warns Drug Makers Over Tactics That Limit Supplies, it appears that she is now conflating two issues that have no relation to one another i.e. "pay to delay" and drug shortages. The former is a practice that Klobuchar, correctly, is against. This blogger is in agreement. However, while "pay to delay" has an adverse financial impact on consumers by delaying price decreases to legend drugs (by delaying the increased competition by generics), it has practically nothing to do with drug shortages. Data on the causes of drug shortages (e.g. from the FDA) do not assign any meaningful number of shortages to issues related to "pay for delay."

Throw this in, and now this blogger is inclined to believe she hasn't taken the time to delve into this issue, that she is not really serious about, and perhaps the free publicity is the draw...

Previous blog entries on drug shortages:
Polarization? - Dec 2nd, 2011
Help on the way? - Jul 31st, 2011
Random charts - Apr 6th, 2011
The why's of drug shortages - Mar 3oth, 2011

Final note: The article also includes this: "... Pay-for-delay tactics can aggravate overall drug shortages, said Stephen Schondelmeyer, an expert in pharmaceutical economics at the University of Minnesota. If generic drugmakers know they can reap multimillion-dollar settlements for trying to replicate top brand-name drugs, they'll feel no urgency to invest in needed but low-profit medications, he said..." I'm not sure who this "expert" is, but if this is an exact quote (see bolded), then it makes no sense whatsoever!

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