Could deaths and illnesses in a fungal meningitis outbreak associated with contaminated epidural steroid injections been prevented with better federal oversight? A new commentary published online in The New England Journal of Medicine (NEJM) argues that it’s possible.

According to the U.S. Centers for Disease Control (CDC), 414 cases of fungal meningitis have been reported in people who received steroid shots prepared by the New England Compounding Center (NECC) to treat back pain, while 14 peripheral joint infections have been reported in patients who received the injections in knees, hips and other joints. Some meningitis victims have also developed a second infection, epidural abscesses, at the site of their steroid injection, despite being treated with powerful antifungal drugs.

Compounding pharmacies like NECC are lightly regulated by the federal government, and among other things, are not bound by the U.S. Food & Drug Administration‘s (FDA) good manufacturing practices standards. For the most part, oversight is left to the states. After the meningitis outbreak was linked to NECC steroids, an FDA inspection turned up unsanitary conditions, including mold contamination, at the NECC facility in Framingham, Massachusetts. The state and federal probe of NECC has also found evidence that it may have been operating as a large-scale drug manufacturer. NECC and other compounding pharmacies are only licensed to manufacture custom medications for individual patients.

The new commentary in the NEJM was authored by Boston University law professor Kevin Outterson, who specializes in healthcare law, according to The Los Angeles Times. Outterson posits that the outbreak could have been prevented if a 1997 law that would have given the FDA regulatory authority over compounding facilities had not been overturned by the U.S. Supreme Court. Among other things, the law – an amendment to the Food, Drug and Cosmetic Act known as Section 503A -forbid compounding pharmacies from advertising the drugs they sold. It was based on the rationale that because compounding pharmacies are only permitted to manufacture individual, customized drugs, such advertising was unwarranted. But a group of compounding pharmacies challenged the law, arguing it violated the First Amendment. Five of nine justices on the Supreme Court agreed, and the rest of the law’s provisions were left in “regulatory limbo,” according to the Times.

“If Section 503A had not been struck down, both the FDA and Massachusetts would have been more directly involved in regulating NECC for more than a decade,” Outterson wrote.

“Regulators need a strong mandate to protect the public health,” the commentary asserts. “Too many patients have suffered and died as a result of compounding errors, which should be made a thing of the past.”

According to The Los Angeles Times, the NEJM is throwing its support behind a new bill sponsored by Democrats in Congress that would make pharmacies like NECC that “operate as drug manufacturers” accountable to FDA regulations.

Several meningitis lawsuits have already been filed against NECC by alleged victims of the company’s recalled steroids. If you or a loved one developed meningitis or another fungal infection following a steroid injection, you may be eligible for compensation for your pain and suffering. To learn more about filing a fungal meningitis lawsuit, please contact an attorney at Bernstein Liebhard LLP by calling 1-877-779-1414 today.

Published November 9, 2012 by