Last month @Paul Giffen from AstraZeneca presented the ECHA proposal to ban all PFAS molecules before our Open Scientific Discussion about Biodegradability in Pharma by Dr. Sebastian Foertsch, Senior Scientist from iff.
ECHA has taken a blanket approach to classification of PFAS (any molecule with a CF3 motif) arguing that all result in environmental accumulation of toxic trifluoracetic acid in water/soil, etc., and leading to human health issues. They, therefore, classify all PFAS as persistent, bio-accumulative, and toxic. This is a broad position.
Legislation may impact the acceptance of fluorinated gases as propellants in inhaled pMDI products. APIs are excluded from the proposal given their undoubted health benefits.
Should excipients also be exempt? They are essential to drug delivery and efficacy. Excipients are heavily regulated in terms of safety. This would affect excipient manufacture, storage, container closure systems and medical devices. In lieu of a virtual Open Scientific Discussion for July, please share your thoughts of how to influence this process or formal response in this thread. The visual and ~ 8 minute audio recording is attached.
We would like to schedule an virtual Open Scientific Discussion in August and open to partnering with another community.
Excipients Leadership
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Allison Radwick Ph.D.
Sr Regulatory & Policy Comms Mgr
USP
Rockville MD
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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