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FDA: Help wanted

FDA: Help wanted
FDA has been approving record numbers of new drugs and has lots of tools in its toolkit now to get important new treatments onto the market. Recent gains in regulatory efficiency cannot be sustained, however, if the agency’s persistent challenge in building and maintaining its workforce isn’t addressed pronto. The 2016 to-do list enumerated by the FDA’s Center for Drug Evaluation and Research Director Janet Woodcock in a recent presentation is exciting yet overwhelming, and her center alone is short more than 600 staff. Changes in federal hiring policies and practices are urgently needed to allow FDA to effectively compete for the highly specialized staff it needs. The drumbeat of concern about this issue began almost a decade ago; time is now of the essence as we expect more innovation like the recent spate of activity in immunotherapy to come barreling through the pipeline at FDA. This team needs more players on its roster, a point the likely incoming FDA Commissioner Dr. Rob Califf - a Duke basketball fan - will surely appreciate.
Academic research: The Next Generation or final frontier?
The state of the academic research workforce is another issue that has been the subject of concern for some time but seems to be reaching a state of crisis. Many are familiar with the statistic that NIH grantees are now on average 42 years old at the time of their first R01 grant. Nature published a stunning graphin 2015 showing that researchers under age 35 received more than 20 percent of R01 grants in 1980 but receive fewer than 5 percent today. Bruce Alberts and colleagues claimed in a PNAS article in 2014 that we’ve produced an “unsustainable, hypercompetitive” system and that we’re producing too many researchers for the number of positions available. Conversely, many senior academic researchers are concerned that they don’t have junior faculty to whom to “pass the baton.” Forums like Future of Research are springing up to give young researchers a voice in their own futures. Could 2016 be the year we begin to see some serious experimentation at academic institutions with “the way we’ve always done things” - upending the system of eternal post-docs, publication, tenure, the stigma of spending even part of one’s career outside of academia? We certainly hope so.
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