Fungal Meningitis Outbreak Leads To Calls For More Regulation

Congressional investigators looking into the deadly fungal meningitis outbreak have discovered that the FDA previously tried to close down the New England Compounding Center — the specialty pharmacy responsible for the outbreak.

Inspectors sought to close the NECC about 10 years ago until it was able to clean up its operations, reports CBS News. The latest report released has caused officials and the public to call for more regulation on the compounding industry.

As of the latest count, 428 people have been diagnosed with fungal meningitis stemming from a steroid injection they received for pain. The steroid shots, which came from the New England Compounding Center, have been identified as the cause.

Since the outbreak began in September, 32 people have been killed from the shots while an additional 10 cases of fungal joint infections have been reported by patients who received the injection in their knee, hip, shoulder, and elbow.

The massive fungal meningitis outbreak has put the pharmacy at the center of a congressional probe, which opened this week, as well as calls for greater regulation of compounding pharmacies, which have long operated in a legal gray area between federal and state laws.

Reuters notes that the chief public health officer of Massachusetts has called on Congress to immediately bolster federal oversight of the lightly regulated compounding industry, which is mainly overseen by state pharmacy boards.

Dr. Lauren Smith, the interim commissioner of the Massachusetts Department of Public Health, stated, “It is clear that the patchwork of disparate state regulations is not enough to keep the public safe.”

A US House of Representatives oversight panel will review the extensive report released by the FDA regarding the outbreak and problems discovered at the New England Compounding Center in an investigation after the fungal meningitis outbreak began.

Lawmakers are looking to shed light on why regulators did not act against the NECC despite multiple problems with the specialty pharmacy dating back to 1999. They will also focus on whether new legislation is needed to grant the FDA clear authority over the drug compounding industry. The federal agency’s statement to Reuters reads:

“FDA’s authority over compounding pharmacies is more limited by law and needs to be strengthened. We look forward to working with Congress to prevent this from happening again.”

FDA Commissioner Margaret Hamburg and Smith are set to testify before the panel on Wednesday to talk about the fungal meningitis outbreak and whether the FDA needs legislation to regulate the compounding industry.