DOGE cuts cause FDA to delay decision on hereditary disease drug
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The Food and Drug Administration will miss a deadline this week deciding whether to approve a drug for a potentially life-threatening genetic disorder because of "heavy workload and limited resources," manufacturer KalVista Pharmaceuticals said.
Why it matters: It appears to be the first time an FDA review had to be extended because of DOGE-directed cuts to staff at the agency.
The big picture: Health industries pay billions developing and shepherding drugs, devices and tests through the regulatory process, including user fees that help ensure there's enough staff to evaluate products on a predictable timeline.
- Drug companies previously expressed concerns that the timeframes for these sorts of decisions would begin slipping because of staff and budget cuts.
KalVista said the FDA notified the company it would miss its decision date of June 17 for a new drug application for the oral drug, called sebetralstat, that targets hereditary angioedema.
- The condition is a rare genetic disorder that causes debilitating attacks of tissue swelling in various locations of the body.
- The agency did not request any additional data or studies or raise concerns about the drug, the company said. It indicated it expects to deliver a decision within approximately four weeks, the company said.
What they're saying: "One delay does not a trend make," wrote Chris Meekins, a Raymond James analyst and health official in the first Trump administration.
- "While it is certainly possible this delay is the canary in the coal mine, there are many potential reasons why this delay could be a one-off event," he added. "For example, are staff who failed to do their job now using the cuts as an excuse for their own failures, or is the delay a result of normal staff being out on leave?"
