The coronavirus pandemic led biotechnology and pharmaceutical companies to delay clinical trials for potentially life-changing drugs.
This is true for companies like Eli Lilly, which told Reuters in March that the delaying of trials would delay its developing experimental gastrointestinal disease treatment, mirikizumab.
Bristol Myers Squibb, Pfizer, and several other companies also said they would postpone new clinical trials and studies amid the pandemic. According to CNBC, some pharmaceutical companies have resumed trials, but experts say the full impact of delays may remain unknown for months.
One factor in determining the effects of the delays is the Food and Drug Administration (FDA). Former FDA Commissioner Scott Gottlie told CNBC that the delays might cause a “burst of activity” once drugmakers do complete this halted trials.
This is because once a new drug application is submitted to the FDA, it can take up to a year to determine the drug’s safety and effectiveness, per the FDA website.
With the pandemic, it could take even longer. The FDA said last month that since so many staff members are working to combat the coronavirus, “it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely.”
The FDA made a website for pharmaceutical companies to reference for information about clinical trials amid the pandemic.
“We are working around the clock to monitor and mitigate emerging coronavirus-related issues with our federal partners, international regulators, and medical product developers and manufacturers to advance response efforts to combat the coronavirus disease (COVID-19) outbreak,” an FDA spokesperson told CNBC.
“Our application review teams remain focused on their work, and we are doing everything possible to maintain continuity of operations in a very dynamic situation and will continue to be flexible and as transparent as possible.”
This article was originally published by Business Insider.
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