Posted: 01 Jul 2018 11:08 PM PDT
By Jeffrey N. Gibbs and David A. Gibbs* –
FDA’s premarket approval (PMA) advisory panels are high visibility events. Both FDA and companies invest heavily in preparing for these meetings.
Thus, when the rules governing PMA panel meetings change, it should be big news. Yet, when FDA revised its procedures on how panels voted in 2010, it didn’t create much of a stir. After all, the changes – going to simultaneous blind voting and asking for separate votes on safety, effectiveness, and benefit-risk – seemed like minor procedural alterations.
Yet, procedural changes can influence outcomes. Thus, we asked what impact these changes had? To do so, we looked at 37 panel votes before the change and 52 votes after the change. The results of the analysis were recently published.
One might have expected the switch to blinded voting to lead to more divided outcomes, since panel members would not be swayed by early voting patterns or dominant voices. The data did not show that. Obviously, other forces could be in play, such as better applications going to panels, and better PMAs presumably would lead to more uniform votes. Still, the results are intriguing and unexpected.
The study found some other interesting patterns. To see what they are, read the article.
Of course, the panel vote is only one part of the process. What’s most important is the ultimate outcome. Our analysis of the data also evaluated the relationship between panel votes and FDA’s final answer: approval or not. These results will be published in a forthcoming article. Stay tuned. You may be surprised by what we found.
*David A. Gibbs is a research analyst at the World Resource Institute in Washington, D.C.
FDA’s premarket approval (PMA) advisory panels are high visibility events. Both FDA and companies invest heavily in preparing for these meetings.
Thus, when the rules governing PMA panel meetings change, it should be big news. Yet, when FDA revised its procedures on how panels voted in 2010, it didn’t create much of a stir. After all, the changes – going to simultaneous blind voting and asking for separate votes on safety, effectiveness, and benefit-risk – seemed like minor procedural alterations.
Yet, procedural changes can influence outcomes. Thus, we asked what impact these changes had? To do so, we looked at 37 panel votes before the change and 52 votes after the change. The results of the analysis were recently published.
One might have expected the switch to blinded voting to lead to more divided outcomes, since panel members would not be swayed by early voting patterns or dominant voices. The data did not show that. Obviously, other forces could be in play, such as better applications going to panels, and better PMAs presumably would lead to more uniform votes. Still, the results are intriguing and unexpected.
The study found some other interesting patterns. To see what they are, read the article.
Of course, the panel vote is only one part of the process. What’s most important is the ultimate outcome. Our analysis of the data also evaluated the relationship between panel votes and FDA’s final answer: approval or not. These results will be published in a forthcoming article. Stay tuned. You may be surprised by what we found.
*David A. Gibbs is a research analyst at the World Resource Institute in Washington, D.C.
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