U.S. Senators Bob Corker and Lamar Alexander are leading the investigation into the fungal meningitis scandal, where tens of thousands of vials of a steroid were contaminated and distributed across the U.S.
As the Digital Journal reported, a steroid product, made at a compounding pharmacy, was distributed across 23 U.S. states to reduce the inflammation triggered by arthritis. The steroid was contaminated during the preparation with a fungus.
The contamination related to sealed vials of methylprednisolone acetate injection, made by the New England Compounding Center’s (NECC) Framingham, Massachusetts site.
Before the contamination was realized, over 13,000 vials had been distributed and many administered into patients (via an injection into the spinal cord). For many of those injected, fungal meningitis developed. This has led to fifteen deaths and some 198 people are reported as sick, according to figures issued by the Center for Disease Control (CDC).
The contamination represents one of the most serious medicinal product infection issues ever. Currently, the CDC, together with with state and local health departments and the Food and Drug Administration (FDA) are investigating this multistate fungal meningitis outbreak.
According to the FDA: "FDA is continuing to actively investigate this situation. It is our goal to contain the health risk as quickly as possible. FDA considers this to be one of our top priorities and we are dedicating many resources to this investigation."
There are however questions about both the New England Compounding Center and the regulatory oversight of compounding pharmacies. Compounding pharmacies are pharmaceutical companies which take medicines and repackage them. This can involve moving the medicine from one container into another.
In response U.S. Senators Bob Corker and Lamar Alexander, sent a letter to FDA Commissioner Margaret Hamburg, on October 12, asking for clarity regarding existing laws governing oversight of compounding pharmacies. The senators also requested information about any inspections of NECC. Given that the FDA inspected the site in 2006, and issued a warning letter in relation to quality control, the senators have asked if the FDA followed up the actions.
The questions that the senators are keen to have answered are:
a) What authority does the FDA have over compounding pharmacies under current law? To what extent does the FDA exercise this authority?
b) What is the nature of the FDA’s relationship with state boards of pharmacy? How does the FDA coordinate with these boards to regulate compounding pharmacies?
c) How does the FDA define a compounding pharmacy? Is this definition used by the state boards of pharmacy when granting licensure?
d) Has the FDA ever inspected NECC’s facility? If so, what dates did such inspections occur?
e) What actions have been taken since your agency sent a warning letter to NECC in December 2006? To your knowledge, what actions has the Massachusetts Board of Pharmacy taken since that letter?
These questions are of importance in trying to find out the root cause for the contaminated medicines and may lead to stricter controls being put on U.S. pharmacies in the future.