User-fee inaction could cause logjam

Share this article:

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. ”
Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Features

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Is your marketing strategy stuck in 2005?

Is your marketing strategy stuck in 2005?

It is not enough to just have a killer black book or Rolodex. The market needs agile, swift marketing

Is guidance stifling social media?

Recent FDA draft guidance was meant to help companies create FDA-compliant tweets and handle third-party misinformation on the web. What other obstacles lie in the path of effective social media use?

FDA social media guides draw flak

FDA social media guides draw flak

Two FDA guidance documents on how health product manufacturers may participate in social media have drawn criticism from industry and consumer groups.