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New research highlights how biases play a role in FDA drug approvals

Published on 25/06/20 at 11:23am
Photo by FDA/CDC

A new study has highlighted how human biases affect the regulatory approval process of the FDA.

The study was carried out by Professor Francisco Polidoro Jr an associated management professor at Texas McCombs at the University of Texas and it was published in Strategic Management Journal. Polidoro reviewed 291 FDA approved drugs over 35 years, and discovered that new drugs take longer to be approved if similar drugs already exist that target that specific condition. He highlights that new drugs take 75% longer to be approved when going up against popular pre-existing ones.

In his review of the drug approvals, Polidoro divided the drugs into 18 therapeutics classes and determined whether the new product used an mechanism that had not been approved before in that class. To assess the FDA’s knowledge of the existing drugs, he counted the number of papers published in medical journals for each class. The more research that old drugs have, the more pressure they would feel to judge new entries by the same criteria as the old drugs. This is despite new drugs often working in different ways.

He also found that the more papers that existed for a class of drug, the longer it took for new drugs to be approved. When the measure of papers increased by 32% beyond the average, the result was a 75% longer approval time.

This also helps pharmaceutical companies keep a hold over their branded and generic versions of drugs. Polidoro believes that regulators inherently “search for solutions in the neighbourhood of what they already know. They have a harder time when the next big thing emerges.”

Conor Kavanagh

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