Showing posts with label 2013 | By Nick Paul Taylor Read more: FDA says scale of compounding problem is unclear. Show all posts
Showing posts with label 2013 | By Nick Paul Taylor Read more: FDA says scale of compounding problem is unclear. Show all posts

Monday, May 13, 2013

FDA says scale of compounding problem is unclear May 13, 2013 | By Nick Paul Taylor Read more: 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 New England Compounding Center (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 her colleague 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.


Read more: FDA says scale of compounding problem is unclear - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-says-scale-compounding-problem-unclear/2013-05-13#ixzz2TEiWS5vk
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