FDA and advisory panels mostly on the same page

Share this article:
FDA and advisory panels mostly on the same page
FDA and advisory panels mostly on the same page

A McKinsey Center for Government analysis shows that in the period 2001-2010, FDA approved 88% of NDAs and BLAs that were supported by advisory committees and did not approve 86% of those not endorsed by the committees.

“When the approval decision made by FDA differed from the recommendation of the advisory committee, FDA did so at the same rate regardless of whether the panel endorsed approval,” the report says.

The McKinsey team found that in 87% of committee meetings, the result was a clear “yes” or “no” vote, possibly due to committee members' expertise in their field that allows them to readily address areas of uncertainty in an application. Another possible explanation, the report says, is a “herding” effect in which influential members convince others of their point of view.

McKinsey says its results have important implications for companies preparing for potential advisory committee meetings. “We believe that the use of bodies akin to advisory committees could be considerably expanded by industry,” the report says.

“Companies currently use mock advisory panels to help rehearse and prepare for advisory committee meetings,” it notes. “Given the sensitivity and specificity of the approach, companies may be better served by incorporating the approach into decision-making, not merely preparation.”

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

Email Newsletters

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?