Additional concerns emerge as fungal meningitis outbreak expands

The fungal meningitis outbreak, linked to contaminated steroids produced and distributed by New England Compounding Center (NECC), has grown to 214 cases and 15 deaths. Health officials are working with medical professionals in 23 states to reach out to the more than 14,000 patients who may have been exposed to meningitis through contaminated injections. There are currently 214 confirmed cases in 15 states including Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

Last week, two companies also owned by the owners of NECC, Ameridose LLC and Alaunus Pharmaceutical LLC, suspended operations while state and federal officials inspect the facilities and regulators investigate the companies’ business relationship. Despite email communications from NECC employees referring to Ameridose as “our sister company,” company officials maintain that the companies are separate entities with “distinct operational management.”

On October 11th, the first lawsuit was filed over the deadly fungal meningitis outbreak in a Minnesota federal district court. Two more cases were filed this week in Tennessee and Michigan.

The company is facing intense scrutiny from officials in multiple states. Officials in Massachusetts are investigating claims that NECC provided prescription drugs to doctors and health care facilities without receiving the individual patients’ names and prescriptions. Officials in Michigan suspended NECC’s license and launched an inquiry into whether the company violated terms of its license by shipping large quantities of drugs for general use. The company is also being investigated in Indiana, Minnesota and Ohio and at least two other states have administration hearings scheduled regarding possible violations of state license regulations.

Across the country, members of Congress have vowed to introduce legislation that would provide the Food and Drug Administration (FDA) greater authority to license and regulate compounding pharmacies. Compounding pharmacies combine, mix, or alter ingredients to create customized medications in order to meet the specific needs of an individual patient. In response to the growing demand for cheaper prescription drugs, the number of compounding pharmacies has increased drastically over the last few years. According to the International Academy of Compounding Pharmacists, compounding is a $3 billion a year business with more than 7,500 compounding pharmacies in the U.S. Under the current regulatory structure, oversight of compounding pharmacies is shared between the FDA and state agencies. However, federal legislation gives the FDA very little authority over compounding pharmacies when compared to the agency’s more comprehensive regulatory oversight of large drug manufacturers. The medications, creams and solutions created by compounding pharmacies are not approved by the FDA for safety and effectiveness.

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