As promised, FDA misses deadlines

October 20, 2008 — 10:01am ET |
By Tracy Staton

Is the FDA dragging its feet these days? Well, it’s certainly missing lots of deadlines. We all know by now that the agency didn’t decide the fate of prasugrel, the Eli Lilly and Daiichi Sankyo blood thinner, by Sept. 26 as promised; in fact, FDA still hasn’t decided almost a month later. Today, the news is that the drug watchdog won’t meet its October target date on TAK-390MR, a Takeda candidate for treating gastric reflux. The company announced that the delay will last at least three months.

And those are just a couple of the latest examples. Here’s a list of the rest of FDA’s delays this year:

  • Promacta, a GlaxoSmithKline treatment for a clotting disorder; FDA missed the Sept. 19 deadline and has not yet made a decision
  • Nplate, Amgen’s clotting disorder med, was supposed to get the agency’s yea or nay July 23, but the approval didn’t come until Aug. 22.
  • Telavancin, a Theravance antibiotic, was scheduled for a decision by July 21; now, it’s scheduled for an FDA advisory panel hearing Nov. 19.
  • Entereg, a GSK/Adolor drug for complications from bowel surgery, was approved May 20, 10 days after the deadline.
  • Cimzia, a Crohn’s disease treatment from UCB, was supposed to get FDA’s ruling March 30, but the drug was finally approved April 22.
  • Lexiscan, a heart-imaging candidate from CV Therapeutics and Astellas Pharma, was due for a decision March 14; it was approved April 10.
  • Kynapid, an atrial fibrillation med from Cardiome Pharma and Astellas, was scheduled for a yea or nay by January 19. The companies announced in August that the FDA had requested more info for the application.
  • And finally, another recent example: The FDA has said it will miss the Oct. 27 deadline on Takeda’s diabetes treatment alogliptin.

You’ll recall that earlier this year, the FDA warned that it would probably start missing deadlines because of a staffing crunch. And observers have commented that the agency seems to be hesitant at the approval trigger, perhaps because it’s gun-shy after a variety of high-profile drug safety problems. Meanwhile, the agency has been scrambling to fill vacant positions and bring on additional help. Only time will tell whether the additional workers can speed up the process.

– read Takeda’s release
– see the post at Pharmalot

Related Articles:
September FDA news in review
Study reaffirms safety flags for last-minute approvals
An early look at FDA trends
Study: Last-minute drugs less safe
On-deadline drug data disputed

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