If Congress does with FDA user fee bills this year what it did in 2007—and in all likelihood it will—the prospects for a huge new products-review backlog are “frightening,” according to FDA Matters editor Steven Grossman. “As a general precaution,” he wrote in a January 30 commentary, “FDA left many staff positions vacant during 2007, just in case the user fee monies were not renewed. As required by law, FDA eventually issued layoff notices to employees it could not pay if user fee monies were not available on October 1, 2007.”
This led to a review backlog starting in the second half of 2007, Grossman writes. “It seems more than a coincidence that the problems started at the same time as the disruption caused by the new law.”
This year, he says, Congress must handle twice as many bills before July 1—drug and device renewals, and bills for generic drugs and biosimilars/interchangeable biologics. “If 2012 becomes a repeat of 2007, then FDA will find itself under withering criticism this year for not reviewing innovative drug applications in a timely fashion.”
Grossman concludes that “Congress needs to commit to speed up the process, minimize amendments, and make new provisions effective six months or a year after enactment. ”
From the March 01, 2012 Issue of MM+M - Medical Marketing and Media
