Meningitis Tragedy Highlights Need For Proper Regulation
In a state that rightfully boasts the global renown of its health care industry, as well as being ahead of the rest of the nation in providing health care for all, the fact that a deadly nationwide meningitis outbreak originated in Massachusetts is a global embarrassment.
The tragedy that began at the New England Compounding Center (NECC) in Framingham was due in part to a failure of federal and state government oversight. According to published reports, state pharmacy regulators were either indifferent in their oversight of NECC or just plain missed critical flaws in its production process. In testimony before state lawmakers earlier this month, according to State House News Service, Patrick administration officials said they're not sure who made the decision to relax sanctions recommended by the state pharmacy oversight board against NECC back in 2006. At the time, NECC was cited for producing contaminated steroids similar to those linked to the outbreak that has claimed more than 30 lives and sickened many more. That kind of excuse by the state is too little too late, and shows a galling lack of accountability in the system.
Certainly, state and federal authorities, with the clarity of hindsight, could have performed their jobs better to prevent — first — the illnesses and loss of life, and — second — the additional scrutiny that will almost surely follow the entire industry.
In that same hearing, two officials with the Board of Registration in Pharmacy noted that resources have been stretched thin, preventing inspectors from being as proactive as they could have been, and instead responding mostly to complaints. "At this time we have additional resources, but in past years leading up to this it was very difficult," said Samuel Penta, the board's supervising inspector. In an industry that's on the front lines of public health, that's beyond unacceptable and must be corrected to prevent similar tragedies from occurring.
Yes, that means better regulation, and while that's often a dirty word in business, even business executives who live and breathe the free-market mantra can concede there is a proper and necessary role for government oversight. This is, clearly, one of those cases.
There has at least been initial action. Last month, Gov. Deval Patrick said the pharmacy board will start conducting unannounced inspections — at least annually — of compounding pharmacies that prepare injectable medications. And, the pharmacies will be required to submit annual production, volume and medication distribution reports.
Since the U.S. Food and Drug Administration is responsible for the oversight of drug manufacturers, it needs to help define the states' jurisdiction so that both federal and state regulators are on the same page. When it comes to the public health, there should be no ambiguity of roles and rules.
D.C. WORK ORDER
A highly contentious campaign season is now over, yielding little change in Congress and none in the White House. But one message became crystal clear, no matter who won your vote this month: Business needs a deal on the “fiscal cliff" — and soon — if we are to fully recover back into growth mode post-Great Recession.
Judging from recent statements by both sides, it's at least creeping toward a compromise. But there is still plenty of room for the more ideological sides of both parties to scuttle a compromise. Even before the election, more than 80 CEOs from major U.S. corporations urged Congress, or rather, pleaded with it, to find a bipartisan solution, going so far as to say that raising taxes is unavoidable.
A recent study by Bank of America said small-business owners in the Boston area are optimistic about 2013. While that doesn't equal prosperity, attitude can go a long way, and Washington must do all it can to maintain that momentum by forging a deal.
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