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Oftentimes prior to the U.S. Food and Drug Administration (FDA) making a regulatory decision regarding potential approval of a new drug, the clinical data will be reviewed and debated by an advisory committee. That committee can then recommend approval or rejection.

While the advisory committees’ recommendations are not binding, the FDA typically follows those endorsements when it comes to final approval of a new drug. A recent study conducted by the Milbank Quarterly found that the FDA followed the guidelines of the scientific advisory committees 78% of the time. To come to that conclusion, researchers examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015.

Over the course of the years examined by the researchers, there were 376 voting meetings that were held by advisory committees. During that time, the researcher found evidence that showed the FDA only deviated from the recommendation of the advisory committee 22% of the time. Of those decisions that were discordant, the researchers said 75% resulted in the FDA approving a drug with more restrictive decisions following favorable committee recommendations. The other 25% resulted in the agency making less restrictive decisions after unfavorable committee recommendations.

https://www.biospace.com/article/a-look-at-the-relationship-between-fda-advisory-committees-the-agency-and-drug-approvals/