FDA Agency Update December 2015

As 2015 comes to a close for the FDA, it remains an agency in transition. The agency should soon see a new commissioner and may be the subject of legislative overhauls. We have recently reported on the FDA's new patient engagement advisory committee, anticipated biosimilars naming guidance, PDUFA reauthorization, and continued issuance of warning letters.
FDA funding, drug approvals: key concerns
RAPS reported FDA Acting Commissioner Ostroff's recent comments, describing the importance of biomarkers in drug development, inspection policies, and patient-centric approaches. With so much talk of FDA reform, his comments on the agency's role as a regulator may be of importance to industry. "We have to preserve FDA's role as the protector of the American public […] We must not shortchange the standards that have provided safe and effective medical products."
This comes as a coalition of universities, businesses and nonprofits that encourages funding for medical research is pushing for at least $2.8 billion in funding for the FDA next year, an increase of roughly $200 million. Research America published its November 11 letter to Congress, stating it expects "the FDA to assure that these products meet the high standards Americans deserve, and, because lives may hang in the balance, to do so as quickly as possible. The FDA needs adequate resources to meet those expectations."
The Hill also notes that Congress is looking at options to speed up FDA drug approval. In particular, t...

Source: Policy and Medicine - December 3, 2015 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs