Outbreak Spurs Calls for New Controls

At the Wall Street Journal:

As many as 13,000 patients may have been exposed to fungal meningitis from tainted spinal steroid injections, authorities said Monday, as some lawmakers called for bringing certain specialized pharmacies under greater regulatory scrutiny.

The oversight of compounding pharmacies, which create customized versions of medicines, is gaining greater attention as the death and illness tolls in the outbreak continue to rise. On Tuesday, the Centers for Disease Control and Prevention said 11 people had died and 119 people in 10 states had been sickened by fungal meningitis, a rare but potentially deadly inflammation to the brain or central nervous system.

New Jersey is the 10th state to report at least one illness, the Associated Press reported. The other states involved in the outbreak are Tennessee, Michigan, Virginia, Indiana, Florida, Maryland, Minnesota, North Carolina and Ohio.

The CDC said a majority of the thousands exposed to the tainted injections had been contacted and weren't ill. The number of meningitis cases could still rise in the coming days and weeks, but it isn't possible to forecast how many might ultimately get sick, the CDC said. Patients have come down with the illness one-to-four weeks after receiving the injections.

State regulators, federal agencies and the pharmacy industry all share some responsibility for monitoring compounding pharmacies like the New England Compounding Center, the Massachusetts facility that shipped the contaminated steroid tied to the meningitis outbreak. But health officials and lawmakers say these facilities essentially slide through the cracks because no one entity has full responsibility for overseeing them.

"Compounding pharmacies currently fall into a regulatory black hole," Rep. Ed Markey (D., Mass.) wrote in a letter to Margaret Hamburg, Food and Drug Administration commissioner, on Monday.

Sen. Richard Blumenthal (D., Conn.), called for the FDA's oversight authority of the facilities to be extended if necessary, saying that compounding pharmacies' "relative immunity from standards of safety and effectiveness seems anomalous and unacceptable." Mr. Blumenthal is on the Senate committee that oversees how much jurisdiction the FDA has.

If the FDA had full oversight of these pharmacies, it could treat their compounds as new drugs and require the pharmacies to submit clinical trials before the drugs are allowed on the market. It also would have more powers to inspect facilities.

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