WASHINGTON, DC (WUSA) -- The death toll from a fungal meningitis outbreak is 20. As of Thursday, there are 257 cases nationwide. The cases are linked to contaminated steroid injections from the New England Compounding Center in Massachusetts.
Dr. John Dombrowski, Director of the Washington Pain Center and the Chair of theASA Committee on Communications, tells 9News' Anita Brikmanthat thelack of oversight contributed to this crisis.
John Dombrowski, MD says, "If my understanding is correct, FDA was in this lab, in this pharmacy in 2006, and they found they had a problem in 2006. That's 6 years ago. So where was the follow-up with respect to them?"
Dr. Dombrowski is referringaninvestigation of the New England Compounding Center that began in 2004. In 2006, the FDA sent a warning letter to NECC covering multiple alleged violations.
FDA agents raided the NECC facility late Tuesday. On Wednesday, a Congressional panel asked the FDA for documents related to the NECC investigations dating back to 2004. The House panel gave the FDA until October 31st to turn over its documents.
When asked if the compounding centers need more oversight Dr. Dombrowski says, "We just need better oversight, I mean the laws are on the books, they are there. They just need to be enforced. Now whether you need more manpower to enforce it or whatever the case might be, you know, more laws I don't know necessarily help if you don't enforce them."
Compounding pharmancies dramatically increased distribution over the past 10 years due to medication shortages.
Dombrowski says, "So where it was 1 or 2 vials for a particular patient and now becomes thousands of vials, tens of thousands of vials are out there so they are trying to fit a need. But, unfortunately there's, you know, that oversight that the FDA should have."
"We already have the laws on the books, they were there in 2006 is our understanding, so it would be great to have the follow-up that's appropriate."
The American Society of Anesthesiologists (ASA)held an emergency panel during its conference in Washingtonthis week on the fungal meningitis outbreak. They expect to see even more cases in the coming days.
FDA Spokesman Steven Immergut released a statement late Wednesday reacting to these allegations saying:
"The FDA's regulatory authority over compounding pharmacies is more limited by statute than it is for typical drug manufacturers. Compounding pharmacies and pharmacists are responsible for the quality and safety of the drugs they produce for patients. The FDA will continue to act within its existing authorities to protect public health and help ensure the safety of medical products. Once the immediate crisis is contained, the FDA is committed to working with Congress, compounders, the states, and all other stakeholders to strengthen the system to prevent tragedies like this in the future."