600 Meningitis-Linked Shots in California Slipped Through Regulatory “Black Hole”

Wednesday, October 10, 2012

A deadly outbreak of meningitis has been traced back to medicine produced by a specialty pharmacy that the federal government does not regulate. To date, eight people have died and 105 have become ill from a steroid, methylprednisolone acetate, used to treat back pain and joint disorders.

More than 600 people in California have received the shots, although no deaths have been reported in the state. Nearly 400 of the suspect vials were used at a clinic in Visalia.

The drug maker, the New England Compounding Center in Framingham, Massachusetts, reportedly sold more than 13,000 vials, unknown numbers of which were contaminated with a fungus. The vials were shipped to pain clinics located in 23 states.

So far, most of the meningitis cases have appeared in Tennessee, Michigan, Virginia, Indiana, Florida, Maryland, Minnesota, North Carolina,  and Ohio.

Compounding pharmacies mix different drugs together. They have become popular with some doctors and clinics because they offer lower prices than large pharmaceutical companies. But the government has not yet imposed oversight over them.

“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” Kevin Outterson, an associate professor of law at Boston University, told The New York Times.

Massachusetts Democratic Congressman Edward Markey said compounders fall into a federal regulatory “black hole.”

–Noel Brinkerhoff and Ken Broder


To Learn More:

Meningitis Outbreak: 13,000 Got Suspect Steroid Shots (Associated Press)

Scant Oversight of Drug Maker in Fatal Meningitis Outbreak (by Denise Grady, Andrew Pollack and Sabrina Tavernise, New York Times)

In Outbreak, Meningitis Is Reported in 5 States (by Denise Grady, New York Times)

600 Calif. Patients Received Recalled Back Shot (Associated Press)

Meningitis-Linked Steroid Shots Given to 13,000 U.S. Patients: CDC (by Tim Ghianni, Reuters)

More Tainted Vials Possible in Meningitis Case (by Lewis Griswald, Fresno Bee)

FDA Allows Manufacturers to Self-Regulate Safety of New Ingredients (by Noel Brinkerhoff, AllGov)

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