The Key to Better Decisions? Try Simultaneous Voting.

How can organizations make robust decisions when time is short, and the stakes are high? It’s a conundrum not unfamiliar to the U.S. Food and Drug Administration, writes Aine Doris.

Back in 2021, the FDA found itself under tremendous pressure to decide on the approval of the experimental drug aducanumab, designed to slow the progress of Alzheimer’s disease — a debilitating and incurable condition that ranks among the top 10 causes of death in the United States.

Welcomed by the market as a game-changer on its release, aducanumab quickly ran into serious problems. A lack of data on clinical efficacy along with a slew of dangerous side effects meant physicians in their droves were unwilling to prescribe it. Within months of its approval, three FDA advisors resigned in protest, one calling aducanumab, “the worst approval decision that the FDA has made that I can remember.” By the start of 2024, the drug had been pulled by its manufacturers. Of course, with the benefit of hindsight and data from the public’s use of aducanumab, it is easy for us to tell that FDA made the wrong decision then.

But is there a better process that would have given FDA the foresight to make the right decision, under limited information?

The FDA routinely has to evaluate novel drugs and treatments; medical and pharmaceutical products that can impact the wellbeing of millions of Americans. With stakes this high, the FDA is known to tread carefully: assembling different advisory, review, and funding committees providing diverse knowledge and expertise to assess the evidence and decide whether to approve a new drug, or not. As a federal agency, the FDA is also required to maintain scrupulous records that cover its decisions, and how those decisions are made.

Some of this data has been analyzed by Panos Markou, an assistant professor at the University of Virginia’s Darden School of Business, along with Tian Heong Chan, associate professor of information systems and operation management at Emory University’s Goizueta Business School.

Together they scrutinized 17 years’ worth of information, including detailed transcripts from more than 500 FDA advisory committee meetings, to understand the mechanisms and protocols used in FDA decision-making: whether committee members vote to approve products sequentially, with everyone in the room having a say one after another; or if voting happens simultaneously via the push of a button, say, or a show of hands.

Markou and Chan also looked at the impact of sequential versus simultaneous voting to see if there were differences in the quality of the decisions each mechanism produced. Their findings are singular.

Read more about the findings in the full article published here on Emory Business.

Panos Markou co-authored “How Voting Protocols Shape Committee Discussions and Outcomes: New Product Evaluations at the FDA” with Tian Heong Chan of Emory University’s Goizueta Business School.