Meningitis Outbreak Prompts Questions about FDA Authority Over Compounding Companies

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Meningitis Outbreak Prompts Questions about FDA Authority Over Compounding CompaniesOverview: Both Republican and Democratic Senators said that they planned to give the U.S. Food and Drug Administration (FDA) authority over compounding companies following the nationwide fungal meningitis outbreak that stemmed from contaminated steroid injections, according to a report in ABC News. Although the specifics are still up in the air, both political parties in the Senate said that the FDA needed to have more authority over compounding companies, who have traditionally side-stepped the agency’s regulations.

  • Senate plans to give FDA more power over compounding pharmacies, who are not subject to rigorous review because they are not classified as manufacturers
  • The FDA and the Massachusetts Department of Health were criticized for not doing more to stop the New England Compounding Center (NECC), who is being held responsible for the fungal meningitis outbreak
  • NECC is known to have unsanitary facility conditions as early as 2002; its sister company Ameridose was also found to have inadequate conditions  

Senate Hearing

At the close of a Senate hearing last week, FDA commissioner Margaret Hamburg was questioned about why the agency didn’t do more to stop NECC from selling the contaminated injections that caused the fungal meningitis outbreak, especially since the company has a poor track record. Hamburg stated, as she has previously, that the FDA’s power is “limited, unclear, and contested” when it comes to compounding pharmacies. Unlike manufacturers, who are subject to FDA regulations, compounding companies are monitored by state boards of pharmacies. Still, the Senate report concluded that “There were a number of authorities and mechanisms for both federal and state regulators to address this issue, but bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health,”

Fungal Meningitis Outbreak Kills 33 people

So far, the fungal meningitis outbreak has killed 33 people across 19 states. The source of the outbreak is reportedly contaminated vials of steroid injections typically used to treat back pain. At the discovery of the outbreak, the New England Compounding Center (NECC) recalled 17,000 suspect vials. NECC has been known to have unsanitary factory conditions in the past. According to recent reports, NECC’s sister company Ameridose has also been shut down following an investigation that revealed unfit conditions at the facility.