Fiscal 2013 user fee payments by industry may be inaccessible to FDA if
planned budget cuts take effect. While the user fee program largely supports
drug and device reviews, it requires that FDA receive a baseline amount of
taxpayer funds before FDA can use any of that industry money.
The purpose of this baseline “trigger” is to ensure that the user fees are
supplementary to congressional appropriations. However, as a result of the 2011
Super Committee’s failure to cut $1.2 trillion from the federal deficit, the
across-the-board cuts to the FDA’s budget may reduce the taxpayer funds below
the baseline amount. If the trigger is not reached, the government may choose to
sequester the user fees and the FDA would be unable to use the money.
Because an estimated 90 percent of user fees go toward personnel costs, it is
projected that FDA will be forced to lay off employees, the time for review and
approval of drugs and devices will increase and ultimately the market will
suffer the loss of medical product innovation programs.
Anna Edney, “FDA
Drug Review Deal Set to Unravel as Fiscal Cliff Looms”