According to a report in BioCentury, “A few weeks after finishing negotiations with FDA over a PDUFA V deal that seeks to tweak drug oversight with changes to the review process, BIO now plans to propose sweeping changes to the U.S. regulatory system.”
For example:
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
A revamping of the advisory committee process to ensure that conflict-of-interest rules do not prevent FDA from gaining access to needed expertise
A fixed term for the FDA Commissioner to insulate the agency from political pressure. BIO takes political independence a step further, calling for FDA to be removed from HHS and turned into an independent agency with a head who reports directly to the president, like the Environmental Protection Agency.
A refining of FDA’s mission to emphasize its role in biomedical innovation. To bolster FDA’s capacity to advance scientific innovation, BIO wants Congress to lift restrictions on funding the Reagan-Udall Foundation.
Further, BIO calls for the FDA to have a “chief innovation officer with “authority to pilot and develop strategies for implementation of promising scientific and regulatory approaches in review divisions.”
Underscoring the connection between regulatory innovation and PDUFA, a member of BIO’s board of directors will present the organization’s recommendations at a July 7 House Energy and Commerce Committee hearing about PDUFA.
Bravo BIO.
