Steroid scare: A deadly outbreak shows a need for Pa. regulation
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In this political open season on regulations, the public health arena has served up a tragic reminder of why governments have an obligation to set rules on the making and marketing of products that can cause harm as well as good.
Pennsylvania has a special reason to pay attention. As the Post-Gazette's David Templeton reported Saturday, if a Massachusetts pharmacy had not voluntarily recalled a bad batch of steroid shots linked to a deadly outbreak of a rare form of fungal meningitis, Pennsylvania could not have stopped its distribution here.
As of Tuesday afternoon, 199 cases had been confirmed in 10 states and 11 deaths had been reported. Although none of the cases are from Pennsylvania, the state was one of 23 that had received shipments of the steroid. Two pain management clinics -- one in Altoona and also South Hills Pain & Rehab Associates, with facilities in Jefferson Hills, Bethel Park, Monessen and Brentwood -- were involved.
While the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration were moving to curb the threat, with help from the Allegheny County Health Department and the state Health Department, it is alarming to find a hole in the regulatory net big enough for a pharmacy truck to drive through.
One would assume that the state Board of Pharmacy would have this covered or else the state Board of Health would have its own regulations. But the Post-Gazette reported that the state Drug Device and Cosmetic Act requires that only out-of-state businesses with sales staff here must register with the health department if they distribute drugs or medical devices.
As it happens, only Pennsylvania, Georgia and Massachusetts don't require out-of-state drug makers to be licensed to ship drugs within their borders. When so many other states have a tougher rule, that should be a hint to Pennsylvania to follow suit.
Yet this sort of regulation is the very thing that conservative politicians prune to cut the cost of doing business. It would seem sensible enough, but the lack of oversight looks a lot different after lives have been lost.
While the Massachusetts steroid manufacturer should be held accountable, we are not calling for the iron fist of regulation to fall on the pharmaceutical industry in a way that drives up the cost of drugs to patients. But some rule is needed and it doesn't have to be heavy to be reasonable -- as Pennsylvania has learned in this episode.
First Published October 10, 2012 12:00 am