FDA failed to take steps to prevent fungal meningitis - WSLS 10 NBC in Roanoke/Lynchburg Va

FDA failed to take steps to prevent fungal meningitis

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ROANOKE -

A deadly infection is the last thing Ferman Wertz, Cave Spring student Zach Foutz, or Doug Wingate ever expected after receiving a routine spinal injection to help with back pain.

That simple shot proved to be contaminated, creating a fungal meningitis outbreak.

It led to a long, painful battle for Wertz and Foutz.

Nearly a year later Carilion Memorial Hospital and LewisGale Medical Center are still treating two patients each with symptoms of meningitis.

But others weren't so lucky.

According to the Centers for Disease Control, 63 people nationwide died from fungal meningitis because of those contaminated shots, including Doug Wingate.

Scott Sexton is the attorney representing Wingate's family in a $25 million lawsuit against the drug's manufacturer New England Compounding Center (NECC) and Insight Imaging in Roanoke, the company that gave Wingate the contaminated shot.

"You make certain assumptions that (it's) a safe drug, that there's a government agency that's regulating that," Sexton said. "Every single one of the people that we dealt with that was effected by this outbreak was shocked to find that no, that wasn't the case."

By the middle of November, less than two months after the first reported case of meningitis, the U.S. Senate's Health, Education, Labor, and Pensions Committee released a report detailing the outbreak and how it happened.

The report found the NECC was first suspected of producing a drug that caused a form of meningitis in at least two cases more than a decade ago.

The Food and Drug Administration began investigating the company back in August 2002.

Of the samples that were studied in that initial inspection, the reports said "5 of the 16 vials were contaminated with bacteria".

But instead of taking action, the FDA left the enforcement to the Massachusetts Board of Pharmacy.

Compound pharmacies like the NECC tend to fall between the cracks when it comes to regulations.

Pharmacies are regulated by the state and drug manufacturers are regulated by the FDA.

But compound pharmacies manufacture and distribute drugs, meaning there is no one agency they answer to.

In the NECC's case, no action was taken until January 2006, nearly four years after the initial cases of meningitis were found.

We checked to see what sort of discipline the company did in fact face and found only a required inspection by a third party agency.

The NECC was later warned again by the FDA, this time for selling compound drugs without a specific prescription and for selling misbranded drugs.

According to the U.S. Senate report, the FDA then re-asserted its authority to the NECC.

The agency said it would take "enforcement action, including seizure of the firm's products and/or injunction against the firm and its principals".

Despite the warnings, the FDA did not take any action against the NECC until after last fall's outbreak.

"I believe that the FDA didn't act the way that they could have acted," said Salem Republican Congressman Morgan Griffith.

He said there needs to be clarification on how compound pharmacy regulations are enforced.

However, Griffith said the FDA did have the authority to act in this situation.

"I want to make sure that we create the right framework to make sure this doesn't happen again," he said. "There were all kinds of warning bells and whistles going off. We could have saved lives."

We reached out to the FDA about the issue.

A spokesperson e-mailed WSLS 10 a statement saying "NECC is still part of an ongoing investigation, and we are not in position to address specifics about our role with the firm."

The statement continued saying the "FDA has been taking a critical look at our surveillance and enforcement approach to compounding pharmacies to find ways to use our existing authorities more effectively to protect consumers."

The agency also said the laws in place are not clear on how to regulate compound pharmacies.

The NECC declared bankruptcy in December 2012 and issued a recall of all of its drugs.

Coming up Thursday on WSLS 10 at 6 p.m. and on www.wsls.com, we'll explain what's being done to change the laws in place to monitor compound pharmacies.

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