The FDA was blindsided last year when hundreds of patients around the country developed, and dozens died from, infectious meningitis after getting injections from a drug made by New England Compounding Center (NECC). Compounders usually fall under state jurisdiction, but some of them have been manufacturing and shipping drugs around the country. Congress called the FDA on the carpet, asking why the agency hadn't been inspecting the biggest operators.
It is now, and with a vengeance. The agency this week ordered Med Prep Consulting of New Jersey to recall all of its products after 5 bags of magnesium sulfate intravenous solution were found to have mold. While there have been no reports of infections this time, and another 13 bags appeared to be free of contamination, the FDA said it was taking no chances.
The FDA also said that Med Prep Consulting had stopped making and shipping any products under an "Interim Voluntary Consent Order" with the state of New Jersey. Turns out though that this is not the first time that Med Prep has had a run-in with the FDA. It has twice been issued warning letters, once in 2001 and again in 2010 for its practice of repackaging sterile products into smaller quantities for resale.
The renewed interest in compounders stems from the the meningitis outbreak tied to a steroid NECC compounded and which doctors injected into patients to treat pain. As of early this month, 720 of the roughly 1,700 patients injected with the drug had been infected and 48 had died. When the FDA was called in to inspect its Framingham, MA, plant, it found serious sterility problems at the operation and at an affiliated operation. NECC closed down last year and filed for bankruptcy protection in December.
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| FDA Commissioner Margaret Hamburg |
While compounders are traditionally overseen by the states in which they operate, some members of Congress criticized the FDA for not preventing the crisis and FDA Commissioner Margaret Hamburg was called before two committees to explain. She said that when the FDA had previously taken a hard-line approach on compounding it had found itself embroiled in litigation. She asked Congress to pass legislation to sort out the jurisdictional issues, but didn't wait for it to be sorted out before letting compounders know there was a new sheriff in town.
The FDA last month launched inspections of 30 "high risk" compounders that manufacture sterile injectable drugs. It has already posted 15 inspection reports on its website this year. Many of those companies were cited for a variety of shortcomings, often having to do with sterility.
- here's the FDA Med Prep warning
- see the 2010 warning letter
- here's the 2001 warning letter
- read the 15 compounding pharmacy inspection reports