Congressional Hearings into Fungal Meningitis Crisis Reveal Potential Missed Opportunities to Prevent Outbreak

The first Congressional hearings into the fungal meningitis outbreak have already begun.  The House Energy and Commerce Committee has followed the release of a 25 page report on the history of the outbreak that began at the New England Compounding Center (NECC.)  Today's hearings allowed members of Congress to quiz the U.S. Food and Drug Administration (FDA) Chief Margaret Hamburg.

According to the Associated Press (AP,) Representative Cliff Stearns, R-Fla, asked, "After a tragedy like this, the first question we all ask is: could this have been prevented? After an examination of the documents provided by the Massachusetts Board of Pharmacy and the FDA — the answer here appears to be yes."

Missed Opportunities- the Anatomy of a Crisis

Representatives of the House presented a timeline in the hearings focusing on a history of both FDA and Massachusetts Board of Pharmacy inspections over sterility issues.  According to the report, the the Massachusetts Board of Pharmacy investigated 12 separate complaints dating back to the NECC's establishment.  The FDA, in contrast, reportedly investigated 3 separate times since 2002 for sterility issues.

Said the Chair of the House Energy and Commerce Committee, Rep. Fred Upton, R-Mich, "I was stunned and angered to learn that an inspection of the NECC by the FDA and the Mass Board over 10 years ago identified contamination in the very same drug at issue in the current outbreak."

According to the report and the current Congressional hearings, the NECC had a history of troubles with contaminations and sending medication without a prescription.

In her prepared speech to the House Energy and Commerce Committee, the AP reported Chief Hamburg called for laws to further define the jurisdiction over these nontraditional pharmacies.

Are Consumers Still At Risk?

After an estimated 14,000  people received the tainted steroid shots, according to the AP.  An estimated 440 consumers developed nonfatal fungal meningitis and another 32 people died from the infection. 

Early reports were that if consumers passed a month incubation period without symptoms, they could be free from worry over contracting fungal meningitis.  However, recent increases in cases reported have caused regulators to reconsider whether or not that window was truly over.  Consumers who feel ill are encouraged to seek the help of a physician.

Symptoms to be aware of:

  • Fever
  • Headache
  • Stiff neck
  • Nausea and vomiting
  • Photophobia (sensitivity to light)
  • Altered mental status
If you experience the above symptoms, contact your doctor today.  You may also want to contact a skilled product liability attorney to discuss the legal remedies available to you.