Published on
Monday, June 27, 2011
The Biotechnology Industry Organization, the National
Venture Capital Association, and patient advocacy group the National Health
Council are making the rounds on Capitol Hill with FDA innovation proposals.
Some of the key ideas are listed below.
|
•
|
Create
a progressive approval pathway to get new therapies for unmet conditions to
patients rapidly; with intensive surveillance and limits on off-label
prescribing if necessary - BIO
|
|
•
|
Revamp
the advisory committee process to ensure that conflict-of-interest rules do
not prevent FDA from gaining access to needed expertise - BIO, NVCA
|
|
•
|
Create
a fixed term for the FDA Commissioner to insulate the agency from political
pressure - BIO
|
|
•
|
Provide
six or 12 months of data exclusivity to drug companies if they collaborate on
development of a companion diagnostic - NHC
|
|
•
|
Refine
FDA's mission to emphasize its role in biomedical innovation - BIO, NVCA
|