As the impact of the deadly meningitis outbreak grows, questions about FDA’s authority to regulate pharmacy compounding have arisen.
New England Compounding Center Inc.’s (NECC) tainted, injectable steroid, methylprednisolone acetate, is now linked to 461 infections, including 32 deaths. In testimony this week before the House Energy and Commerce Subcommittee on Oversight and Investigations, FDA Commissioner Margaret Hamburg stated, in no uncertain terms, that her Agency needs additional authority to regulate compounding pharmacies.
As we noted in a prior blog post and, according to Dr. Hamburg’s testimony, FDA has deferred to State Boards of Pharmacy for regulation of traditional compounding (i.e., for a single patient pursuant to a clinician’s prescription). Indeed, as noted by Dr. Hamburg, under the Food and Drug Administration Modernization Act of 1997 (FDAMA), compounding is exempt from several regulatory requirements: (1) premarket approval for new drugs; (2) compliance with current good manufacturing practice (cGMP); and (3) adequate directions for use. As part of these conditions, compounding must be performed in response to a specific prescription for a specific patient. Otherwise, as K-V Pharmaceuticals made clear in briefing and oral argument in federal court earlier this year, non-customized “compounding” of drugs is unlawful manufacture. How then is it that FDA does not have authority to regulate non-customized compounding as seen in the case of the tainted steroid produced by NECC?
Some lawmakers questioning the Commissioner seemed skeptical that FDA lacked statutory authority. They sharply questioned Dr. Hamburg’s testimony that clear statutory lines between traditional (i.e., customized, single-patient) and non-traditional compounding are needed. FDAMA appears to do this.
Despite its statements to the contrary, it appears that even FDA knew it had the power to regulate NECC. After all, it seems odd that a federal agency, especially one as strapped for resources as FDA, would waste time sending enforcement letters to entities over which it has no authority. FDA sent a Warning Letter to NECC in December of 2006. In addition, both FDA and the Massachusetts Board of Pharmacy investigated NECC just after complaints began to roll in – as far back as 1998 and, in the case of FDA, as far back as 2002 – the same year that FDA reissued its Compliance Policy Guide (CPG) 460.200: Pharmacy Compounding (reissued May 29, 2002).
Although a 2011 federal court ruling (U.S. v. Franck’s Lab, Inc., M.D. Fla.) is consistent with the notion that FDA lacks the authority to regulate pharmacy compounding, that decision was recently vacated. The appellate hearing scheduled for Nov. 1st before the Eleventh Circuit was, accordingly, mooted on grounds far afield from the merits (i.e., Franck’s is out of business). Without the Eleventh Circuit to determine Franck’s (and his compounding brethren’s) regulatory fate, for now, we are left with yesterday’s somewhat contentious showdown on Capitol Hill.
So . . . does FDA have the authority to regulate pharmacy compounding of drugs when it is not customized for a particular patient? Given the magnitude of this outbreak, time (and we may not need much) will tell.