The Impact of FDA Advisory Committee Votes

REUTERS/Mario Anzuoni (UNITED STATES)

U.S. Food and Drug Administration (FDA) Advisory Committees consist of individuals, recognized as experts in their field, that gather upon FDA request. They generally review new or novel products subject to New Drug Applications (NDAs), Biologics License Applications (BLAs), supplemental New Drug Applications (sNDAs) and supplemental Biologic License Applications (sBLAs). They usually provide marketing approval recommendations that the FDA may or may not choose to follow. This article focuses on the impact of Advisory Committee votes on the FDA decisions between 2008 and 2012, breaking it down by Review Type.

Advisory Committees usually vote on questions related to Safety, Efficacy, and/or Approval. The FDA carefully considers this when making a decision on a product application. Therefore, it is interesting to try and correlate Advisory Committee votes and FDA decisions.

Using one of the new Cortellis Regulatory Intelligence Analytics tools, FDA Advisory Committee Meetings, we analyzed the data of the 169 product-related meetings that occurred between 2008 and 2012 where a FDA decision has been made, plotting their votes on approval questions against the FDA final decision.

5-Year Meeting Quick Facts:

  • 169 Total Meetings
  • 121 Products Approved by the FDA
  • Average Meeting per Year = 33
  • 103 were related to NDAs
  • 31 to BLAs
  • 26 to sNDAs and 9 to sBLAs

A high percentage of products reviewed by FDA advisory committees were granted a Priority designation

Upon acceptance of an application, the FDA grants a review status, defining the speed of the whole decision cycle, ending with the agency’s approval or rejection of the submitted file. We noticed more than 77 applications were granted a Priority status (45.5%), while 77 applications (45.5%) were assigned a Standard designation and 15 (9%) an Orphan designation. Figure 1 shows the annual breakdown by designation type of the applications reviewed by advisory committees that have been approved.

Figure 2

Figure 1

Figure 1: Annual Breakdown of Products by Review Type where the FDA made a Positive Decision on Marketing Approval following an Advisory Committee Meeting, 2008 to 2012. Source: Cortellis Regulatory Intelligence Analytics

Of the 121 products that received FDA approval, 88% (99/121) of committee votes were positive. Of the 48 products that were not approved (not shown), 30 (62.5%) had negative committee votes.

Committee voting predictive power is higher for special designations

A committee predictive power can be derived by calculating the percentage of its “Yes” votes in correlation with the subsequent FDA approval decision, for a product:

Predictive Power = (Committee “\”Yes\” votes / FDA approval decisions for that product cycle) x 100″

It is interesting to note that for Orphan products, the committee voting predictive power is 100%, meaning the FDA always followed committee recommendations. In fact, correlation between committee voting and FDA market approval decision is very high, reaching 90% for products given Priority status and 82% for a standard 10-month review.

Review Type Committee “Yes” Votes FDA Approval Decisions (and predictive power %)
Standard 45 (58.4%) 37 (82%)
Priority 59 (76.6%) 53 (90%)
Orphan 9 (60%) 9 (100%)

Figure 2: Correlation between Committee votes and FDA marketing approval decisions, broken down per review type. Source: Cortellis Regulatory Intelligence Analytics

Focus on the Oncologic Drugs Advisory Committee

Of the 21 products that received FDA approval, 90% (20/21) of ODAC votes were positive. Of the 8 products that were not approved, 6 (75%) had negative committee votes.

Review Type ODAC “Yes” Votes FDA Approval Decisions (and predictive power %)
Standard 5 (22.7%) 4 (75%)
Priority 15 (68.2%) 15 (100%)
Orphan 2 (9.1%) 2 (100%)

Figure 3: Correlation between ODAC votes and FDA marketing approval decisions, broken down per review type. Source: Cortellis Regulatory Intelligence Analytics

The predictive power for meetings reviewed by ODAC is below average for Standard designations, however it is fully predictive for Priority and Orphan products. This may be valuable information for companies that have an upcoming ODAC meeting in 2013.

Find out more about Cortellis Regulatory Analytics here >>

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