The US Food and Drug Administration (FDA) is increasingly finding itself at the center of a burgeoning crisis involving steroid injections compounded by a Massachusetts pharmacy that have so far killed 12 and sickened dozens with meningitis.
Two prominent members of the US House of Representative's Energy and Commerce Committee-the House's legislative vehicle for overseeing FDA and the pharmaceutical industry-have aimed their sights squarely on FDA, calling on the agency to produce additional information regarding what it knew and when.
The legislators, Ed Markey (D-MA) and John Dingell (D-MI), independently sent letters to FDA Commissioner Margaret Hamburg on 10 October.
"How and when did FDA become aware of the extent and scope of New England Compounding Center's (NECC) activities?" asked Markey in his letter. "Did NECC ever assert to FDA that it was not engaging in any of the nine different activities that FDA flagged as having the potential to lead to FDA enforcement actions?"
Dingell's questions-15 of them-focused on many of the same issues as Markey's.
"When was the contamination first reported to FDA?" asked Dingell. "What does FDA consider to be legitimate forms of pharmacy compounding? What volume does FDA consider to be legitimate uses of pharmacy compounding?
"Does FDA have the authority to inspect compounding pharmacies? If yes, when was the last time FDA officials inspected NECC's facility? What were the results of that inspection?"
Does FDA Have Enough Authority to Inspect-and Regulate-Compounders?
Both letters implied that the crux of the issue is FDA's authority to regulate the compounders, which currently exist in a patchwork of regulatory oversight government partially by states, the federal government and nothing at all.
"Does FDA have sufficient authority to oversee compounding pharmacies, such as NECC, now?" asked Dingell. "Does FDA need additional authority to oversee compounding pharmacies?"
A letter by Markey the previous day asked, "Does FDA have the statutory authority it needs to ensure the safety of consumers with respect to drugs made by compounding pharmacies? Does FDA believe that new legislation is needed to strengthen federal oversight over compounding pharmacies?"
Despite the potential for FDA to call for new authority-and funding-for its regulatory mission, it could nevertheless find itself in the firing line of legislators bent on assessing blame for the scandal.
FDA: Between a Rock and a Hard Place
FDA may find its ability to avoid blame complicated by a December 2006 warning letter it sent to NECC stating that it believed it has, "Agency jurisdiction over 'new drugs,' including compounded drugs."
"FDA maintains that, because they are "new drugs" under the FDCA, compounded drugs may not be introduced into interstate commerce without FDA approval," it said at the time.
Since the outbreak of meningitis was first observed, FDA has remained uncharacteristically silent on its authority in the matter, saying only that it has been "working closely" with the Centers for Disease Control and Prevention (CDC), state health departments and the Massachusetts Board of Pharmacy.
FDA has previously maintained that it is willing to accept small-scale compounding, but that large-scale compounding that "exceeds the scope of traditional compounding" would be seen as circumventing federal regulations. Given that understanding, most notably established during the agency's lengthy legal battle with KV Pharmaceuticals, it may be difficult for it to maintain that it believed it did not have sufficient authority to remove NECC's products from the market.
Such concerns were raised by Dingell in his letter. "I am concerned that NECC was operating at such a volume to be outside of what may be considered traditional pharmacy compounding," he said. "Further, I am concerned that a facility with a long history of sterility complaints was allowed to operate at such margins and endanger the lives of thousands of patients."