Wednesday, September 18, 2013

Time for feds to sort out compounding pharmacies

How many Michiganders ought to die of tainted medication before somebody in Congress considers it a problem?

Well, the toll is evidently 19 and counting, according to a recent Gannett Michigan story. Todd Spangler of the Detroit Free Press reported last week that a U.S. House bill offered in response to the meningitis outbreak tied to tainted drugs that killed 19 Michiganders — and affected hundreds of other people across America — seeks to clarify federal authority over certain pharmaceutical providers. Eight of the Michigan deaths are from Livingston County.

Not only is this sort of action overdue, it’s necessary. Pronto.

The government does not exist to confer rights. The government is there to protect rights. Consumers deserve the right to seek medical treatment without wondering if the promised cure will be worse than the disease. State boundaries need not be factors in this equation, but the opposite has been the case so far.

Right now, in the meningitis outbreak, whether treatment is worse than the alternative is a provocative question. The tainted drugs were steroid injections used to treat pain, and have been linked to a Massachusetts compounding pharmacy that was not regulated by the federal Food and Drug Administration. Instead, it was regulated at the state level.

If medication flowing out of Massachusetts is heading to health-care providers in Michigan and many other states, then it only follows that the FDA ought to have a hand in the process to ensure safety across state lines. If not, then the medication shouldn’t cross a border.

That’s part of what’s troubling about the ongoing response to the steroid injections. Congress seems hesitant to draw a firm line between respecting state guidance and allowing the FDA to have a guiding hand in what is allowed to be put on the market. As if public safety has to follow dotted lines on a map, in other words.

Congress also seems leery of giving the feds power over compounding pharmacies when the FDA had notice of problems at the Massachusetts place linked to the meningitis outbreak and did not shut it down. A fine point.

On the other hand, much is to be said for to the road ahead. No bill is ever going to save lives in retrospect. Forward-thinking legislation that addresses a contemporary conflict is on the table, and it deserves serious consideration. With its silence on this meningitis outbreak, Congress speaks volumes about its priorities, which don’t seem to involve eight Michiganders who went into pain treatment and ended up dead.

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