Meningitis outbreak nears 400 infected as lawmakers push for tougher regulation

More than 400 infections have now been tied to an outbreak linked to contaminated steroid shots from the New England Compounding Center, the Centers for Disease Control and Prevention announced Friday.

As of Nov. 2, 395 people have developed fungal meningitis, including 29 deaths. Another nine patients have fungal joint infections from steroid injections they may have received in areas such as the knee, hip, shoulder and elbow.

The ongoing 19-state outbreak of fungal meningitis has been linked back to three lots of methylprednisolone acetate (MPA) steroid injections made by the Compounding Center of Framingham, Mass. The injections were shipped to 23 states and officials have said up to 14,000 patients may have received the contaminated shots, mostly for back pain treatments.

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On Thursday, the Food and Drug Administration had announced that it found bacterial contamination in two other types of drugs made the New England Compounding Center, betamethasone - used to various skin conditions and inflammation - and cardioplegia solution, which is given during heart surgery. No illnesses however have been reported in people who used these drugs.

The agency said the findings bolster concerns about a lack of sterility at the now-closed company. Investigators there have already found standing water from a leaking boiler, filthy floor mats and records indicating drugs were shipped before sterility tests were returned.

The FDA test results were released hours after an announcement Thursday by U.S. Rep. Ed Markey that he'll introduce legislation to strengthen the federal oversight over compounding pharmacies, which custom-mix solutions that generally aren't commercially available. They aren't regulated by the FDA.

Also Thursday, Massachusetts enacted emergency regulations that, like Markey's bill, aim to prevent compounding pharmacies from being regulated like mom-and-pop drug stores if they're actually large drug-making operations.

"Somehow, the New England Compounding Center fell into a regulatory black hole, until it caused the worst public health disaster in our country in recent memory," Markey said.

Markey announced his legislation in a parking lot outside the NECC building in Framingham. A tainted steroid made there, and used to treat back pain, has caused a fungal meningitis outbreak that's spread to 19 states, sickening 377, 28 of whom have died.

Under Markey's legislation, to be introduced Friday, compounding pharmacies would be regulated by the FDA if, like a drug manufacturer, they produce bulk quantities of a medication for general distribution. Officials say that's what NECC was doing, though its state license allowed it only to produce drugs for individual patients with valid prescriptions.

Markey, who sits on a committee with oversight over the FDA, said the company was posing as something it was not to avoid more stringent oversight.

A spokesman for NECC said the company intended to follow the law in whatever state it was licensed in. He didn't comment on Markey's legislation.

The bill also prevents compounding pharmacies from producing copies of commercially available drugs. It requires pharmacies to label compounded drugs to show they haven't been tested by the FDA. And it requires the FDA to compile a list of drugs that aren't safe or effective when compounded.

The legislation is modeled on a 1997 law that was struck down after the U.S. Supreme Court ruled its restrictions on how the companies marketed their drugs violated First Amendment rights.

Markey said his bill avoids that problem by not addressing any marketing restrictions, though he said he still expects the compounding industry to fight it.

David A. Ball, a spokesman for the International Academy of Compounding Pharmacists, said the group was still reviewing the legislation.

"We plan to work closely with members of Congress and their staff in the development of new legislation and/or regulation that will ensure the safest possible practice of compounding," he said.

In Massachusetts on Thursday, the state Board of Registration in Pharmacy passed emergency rules focused on ensuring that compounding pharmacies produce drugs only for patient-specific prescriptions.

The emergency rules require compounding pharmacies to submit biannual reports on how many prescriptions they dispensed and where. They're also required to sign, under the penalty of perjury, affidavits stating that they are only mixing and dispensing prescriptions for individual patients.