AUSTIN, Texas - The standards used to review drug applications may delay the approval for new drugs that could prevent and treat COVID-19.
New research conducted by UT Austin Associate Manager Professor, Francisco Polidoro Jr, has shown that when the Food and Drug Administration has more information about an existing drug, the longer it took for the agency to approve new drugs for the same condition.
“Sometimes knowledge can become a hindrance, and too much of a good thing can become a bad thing,” Polidoro said.
Polidoro reviewed 291 drugs that have been approved over the last 35 years. He found that when there was more information about older drugs, more than half of the newer drugs took more than 20 months to win approval. According to Polidoro, only 20% of new drugs took that long approve when less information was available about the drug. UT Austin says that delays in drug approvals cost their creators an average of $1 million a day.
Hopeful news for a potential COVID-19 treatment was also found in Polidoro's study. He found that when the FDA had to review several innovative drugs in a "relatively short time" of three years, the delays in approvals got shorter.
“As it struggles with innovations, the organization becomes better able to deal with them,” he said. “It gets more used to breaking routines and creating new ones.”
Polidoro defines an innovative drug as one that uses a new mechanism of action to attack a disease.
Concerning COVID-19, Polidoro believes that regulators should be thinking ahead about new standards by which to test drugs.
“It will be difficult to compare these solutions with each other because they have different safety and efficacy profiles,” he said. “They’re not like apples to apples. Recognition of these differences can help ensure timely approvals.”
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