By Elise Viebeck - 10/09/12 06:56 PM EDT
Leading House Democrats are calling on the GOP to investigate a national meningitis outbreak that has killed eight and sickened more than 100.
Reps. Henry Waxman (Calif.), Frank Pallone Jr. (N.J.) and Diana DeGette (Colo.) — all leading Democrats on the Energy and Commerce Committee — wrote to the panel's GOP leaders Tuesday with a call for action.
Health officials suspect the outbreak was caused by steroid injections tainted by fungus. The shots were given to thousands of patients for back and joint pain, though it is unclear how many of the injected are at risk of contracting meningitis.
The drugs came from the New England Compounding Center (NECC), a Framingham, Mass.-based pharmacy that reprocesses drugs on a large scale to fit patients' needs, such as dividing standard medications into doses fit for children.
The NECC sent about 17,700 single-dose vials of the steroid injection to 23 states, according to reports. The highest number of meningitis cases have been reported in Tennessee, also the site of the first diagnosis linked to the NECC.
Critics are wary of compounding pharmacies because they are subject to fewer Food and Drug Administration (FDA) rules than regular drug makers. On Tuesday, Democratic lawmakers raised this concern with Republican leaders, writing that Congress intended compounding to be restricted to "limited instances."
The law "did not intend for a compounding pharmacy to be permitted to operate as a small drug manufacturer," they wrote. "Yet it appears that this is exactly [what] NECC did: it appears it was able to essentially operate as a manufacturer, producing large quantities of the drug, shipping it to hundreds of pain clinics in dozens of states …. all with no oversight from the FDA."
Tuesday's letter is the second time an Energy and Commerce Democrat has demanded answers on the meningitis outbreak this week.
Rep. Edward Markey (D-Mass.) wrote to the FDA on Monday asking about the compounding and regulatory practices that might have led to the outbreak. Compounding pharmacies "currently fall into a regulatory black hole," Markey wrote.
NECC recalled all of its products on Saturday and has surrendered its state license.