FDA says scale of compounding problem is unclear

The FDA has scrambled to get on top of the compounding pharmacy sector in the wake of the fungal meningitis outbreak, but last week it admitted it still faces a fundamental issue--it is unsure of the scale of the problem.

The confession was made by Center for Drug Evaluation and Research (CDER) Director Janet Woodcock at a Senate committee hearing to discuss draft legislation meant to improve oversight. When put on the spot by Massachusetts Senator Elizabeth Warren, Woodcock said: "I think the real problem is that we don't know [how many patients have been harmed]." Woodcock sees the lack of certainty as a consequence of compounding pharmacies facing no obligation to tell the FDA who they are and what they produce. "We have learned that the law is not well-suited to effectively regulate this evolving industry," Woodcock said.

Woodcock backed draft legislation--which draws on recommendations made by Margaret Hamburg--to plug the gaps in regulatory oversight, but she pushed for still greater powers. Specifically, Woodcock wants the FDA to have easy access to compounding pharmacies' internal records. Without this power, the FDA can have to go through local courts for a search warrant if it wants to see documents. In October, FDA investigators obtained a search warrant for the New England Compounding Center site linked to the meningitis outbreak.

The call for access to documents put Woodcock at odds with representatives of the pharmacy industry. Head of the National Association of Boards of Pharmacy Dr. Carmen Catizone backed the current draft but warned against giving the FDA the power to seize documents. The fear is the FDA will seize and withhold documents, making it hard for state investigators to pursue pharmacies. State and federal officials working at cross-purposes have caused problems in the past. Senator Warren said "a lack of coordination between state and federal oversight" had contributed to the failure to properly monitor activities at compounding pharmacies.

- read the RAPS article
- check out the AP piece
- watch a hearing video clip