FDA Between a Budgetary Rock and a Hard Place


Photographer: Joe Raedle/Getty Images

Nov. 20 (Bloomberg) — Nearly 500 cases of meningitis and more than 30 deaths in 19 states from tainted steroids are unsurprisingly leading to calls for greater oversight of the compounding pharmacies that make these drugs.
     But calling for more oversight of compounding pharmacies is easy and unlikely to encounter disagreement. The bigger problem is how to pay for it.
     My Bloomberg Government colleague Brian Rye has no doubt that the FDA could credibly and vigorously regulate the compounding pharmacy industry in the U.S. But doing so comes with a cost to tax payers, pharmacists and patients.
     Rye points out that our fiscally austere times are about to get worse, especially if you are a government agency. The FDA has many responsibilities but limited funds. Regulating compounding pharmacies – a laudable goal – means money will have to be re-directed from food safety, drug facility inspections, or some other important public health task.
     Whether or not we collectively tumble off the fiscal cliff or reach a budget deal, or both, there are limits to what the FDA can do without additional money.
     This problem is symbolic of the hard choices facing elected officials as negotiations over the budget take place. Priorities will have to be set and sacrifices will have to be made.
     Whether the risks posed by compounding pharmacies rise to the level that Congress feels it needs to act – to protect public health or their political posteriors – is the multi-million dollar question.

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