The prominent consumer watchdog group Public Citizen is calling for an investigation into practices at the FDA that allowed a compounding pharmacy to cause a deadly fungal meningitis outbreak that has resulted in life-threatening infections in 17 different states.
In a letter (PDF) sent to U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius on October 24, Public Citizen called for the Office of Inspector General to open an investigation into the FDA’s failure to take action against the New England Compound Center (NECC) in Framingham, Massachusetts, which mixed epidural steroid injections and other medications linked to the outbreak.
NECC distributed more than 17,500 doses of potentially contaminated epidural steroid injections to 76 facilities in 23 different states, causing more than 300 confirmed cases of fungal meningitis, including at least 24 deaths.
The letter notes that the FDA knew there were problems at the compounding pharmacy, but never enforced is authority or moved to ensure that the drugs NECC sent out were legal and safe. The letter also calls the FDA to task for remarks by some officials saying that the FDA did not have clear authority to take action.
“The claims by agency officials that the FDA lacks authority to properly regulate compounding pharmacies is contradicted by a long history of remarkably consistent statements and enforcement actions asserting the agency’s legal authority over such pharmacies,” wrote Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group.
At issue is what legal capabilities the FDA has to move against compounding pharmacies that might be endangering the public. Several years ago the Supreme Court shot down many of the regulations used to rein in the compounding pharmacy industry.
NECC Dodge Compound Pharmacy Restrictions
Compounding pharmacies are supposed to be small operations that supply drugs to local hospitals for very specific patient needs.
In some states, including Massachusetts, a compounding pharmacy must have a prescription from an individual patient in order to create a drug. However, NECC shipped its recalled epidural steroid injections with no such prescriptions.
Since the outbreak, NECC has surrendered its license and now faces a criminal investigation from Massachusetts, potential federal charges and a number of personal injury lawsuits and class action suits over the meningitis outbreak.
Public Citizen suggests that the pharmacy’s actions could have been stopped years before. In 2006, the FDA sent a warning letter outlining many of the problems are believed to have contributed to the current outbreak. The pharmacy was sending out drugs without prescriptions, which the FDA warned made it a drug manufacturer under full FDA jurisdiction. The pharmacy reached a settlement with state and federal agencies that allowed it to dodge a public reprimand and other sanctions.
“While no one relishes being viewed as culpable for a public health crisis, the FDA’s attempt to dodge responsibility in this matter is outrageous,” Public Citizen’s letter states. “The FDA clearly is incapable of conducting an objective evaluation of its own policy, oversight, and enforcement decisions, which clearly contributed to this ongoing preventable tragedy.”
Public Citizen wants the investigation to identify all FDA officials who contributed to the failure to take action against NECC.