FDA paused trials for experimental drugs more often in recent years
Abigail Adcox
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The Food and Drug Administration has increasingly exercised its power to delay drug companies’ testing of experimental drugs in recent years, a possible byproduct of newer medical technologies that offer promise but may pose additional risks.
The agency, which has to sign off before drugmakers can conduct human trials, placed a clinical hold for experimental medicines an average of 664 times each year from 2017 to 2021, up over a hundred from the average of the five years preceding 2017, according to a Wall Street Journal review of FDA data.
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In 2022, the number of holds the FDA placed jumped up to 747 by mid-December.
The agency outlines that grounds for suspending testing of an experimental drug can include a risk of illness or injury to human subjects, clinical investigators failing to meet requirements, or a drugmaker’s study being deficient.
Last year, the FDA put a clinical hold on Vertex’s Type 1 diabetes medication for several months after noting that the data to support its dosing with the product were “insufficient.” The drugmaker has since resumed human trials on the stem cell therapy aimed at treating diabetes.
Last month, the agency lifted a partial hold on BlueBird Bio’s sickle cell treatment for patients under 18 years old that had been in place for a year after an adolescent patient developed anemia following treatment.
An FDA spokesperson told the Wall Street Journal that the rise in clinical holds can likely be attributed to more clinical trials for gene and cell therapies.
“The FDA continues to work with medical product developers and researchers to facilitate the development of new potential treatments,” the spokesperson said. “This includes ensuring that study participants will not be subjected to unreasonable risks in early clinical testing and that study designs address their objectives.”
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Lesser-proven technologies, such as the mRNA technology used in the COVID-19 vaccines, have shown potential but could also pose their own set of risks that could require additional review or further testing.
Researchers in the field have noted that a suspension of trials does not necessarily affect the drug’s approval down the line and is sometimes necessary to safeguard patients and produce safer medicines.