It's Election time. Time for another terrific "white paper" from a Blue Ribbon panel of experts outlining several recommendations as to how the federal Government (e.g. FDA and others) can speed drug approvals.
A White House White Paper On Drug Approvals // Pharmalot.
Like most such august panels, their recommendations in a robust 110 page report is long on advice and short on specifics. Some of these include:
- More funding for National Center for Advancing Translational Sciences (Francis should be happy)
- Create "broad-based" partnership to improve clinical trials and provide the FDA with more input on developing a pathway for "innovative medicines"
- Have the FDA do more to grant accelerated approval for drugs meeting the standard for addressing an "unmet need" for a serious life threatening condition
- Create a new pathwy for initial approval of drugs aimed at specific subgroups, dubbed Special Medical Use approvals
- Have the FDA run pilot studies to look at "adaptive approval mechanisms". Congress should pony up $40 million annually to pay for this
- FDA should enact a "range of reforms', including the use of pre-market review leaders to oversee drug applications from investigative stages to final approval
- USDHHS should commission a study of economic incentives to promote innovation, i.e stimulate companies to chase drugs like treatments for Alzheimer's or antibiotics
So all we have to do is follow the advice -- blah blah blah blah -- and figure out how to put it into concrete actions.
White paper + Blue Ribbon panel = Red Herring. Will it get the Green light?
Posted by Bruce Lehr Sep 29th 2012.
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