Monday, November 26, 2012

NEJM: Bizarro Regulatory Suggestions

The two leading perspective articles in last week's New England Journal of Medicine are striking examples of the bizarre call for regulation when none is need.

The first, Kevin Outterson's Regulating Compounding Pharmacies after NECC is a lawyer's take on changes in the regulatory requirements after the New England Compounding Center fiasco in which hundreds of people were infected with rare fungal disease due to contaminated steroids.  Compounding pharmacies are an interesting entity in modern medicine.  In a time when drug companies and generic manufacturers are stamping out medicines left and right, it is the compounding pharmacy that is allowed to take existing medicines and combine them (or redose them) due to individual physician/patient needs.  Due to their unique role as the individual practice of pharmacy, they have avoided wide-scale regulation like their manufacturing counterparts.   Apparently Congress is already discussing new federal regulations.

However, as Outterson clearly points out, there are State AND FDA regulations in place (that were violated) leading up to these events.  In fact, Massachusetts and the FDA had begun investigating NECC as early as 2002.  He laments that the already overburdened FDA oversight leaves limited opportunity for proactive oversight due to elements of the current rules that were not passed.  Again, the FDA had knowledge of problems at the NECC 10 years prior to the events.  So it would seem that the problems are not a lack of regulations, but the enforcement of existing regulations.  How the passage of new regulations will do anything but punish those already in compliance with additional burdens without catching violators is beyond me.  I guess it is easy to write rules and hard to enforce them, so we might as well keep writing rules and hope that solves the problem.

In a second, Cerreta et al's Drug Policy for an Aging Population - The European Medicines Agency's Geriatric Medicine Strategy reports on the EU's Medicines Agency strategy for evaluating (and theoretically changing) its regulatory strategy in the "development, approval and use of medications."  This process, which started in 2006 produced a strategy 5 years later recognizing that:

  1. The elderly use most of the medicines
  2. Chronological Age alone is inadequate for characterizing frailty ("young old" vs. "older old")
  3. Investigators tend to cherry pick patients often making the results non generalizable
  4. Patients have different preferences and clinical scenarios leading to individual risk/benefit decisions
  5. Hard to open packages are hard to open
  6. Package inserts are hard to read
  7. Drug-Drug interactions are only likely to be picked up after the drug is in use
These are shocking conclusions, certainly worthy of such time and investment.  Furthermore, does this not all fit entirely within information that any producer of a product would like/need to know, and improve upon where possible?  In the backwards world of medicines, product innovation is best preceded by a "regulatory framework."  Because top down innovation has such a clear track record of success.  What could have been done if manufacturers (and new entrants!) had spent the last 5 years free to innovate based on the assumptions above, none of which are particularly ground breaking, nor dangerous enough to require evidence before action.  From the regulators seat, it must be preferable to spend years and untold amounts of money while preventing possible good for millions in order to prevent embarrassing and scandalous possible harm for a few.

And we wonder why our health care is bureaucratized, inefficient, inhuman and unable to innovate itself in over 50 years...

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