It seems like the answer is now ‘yes’. EndPoints reports:
Stealth BioTherapeutics said the FDA would not meet its Tuesday deadline for approving or rejecting the company’s drug, elamipretide. It had been seeking regulatory clearance of elamipretide for a rare disease called Barth syndrome, which affects only about 150 people in the US and causes heart abnormalities and muscle weakness. About 85% of patients don’t make it past the age of 5.
In a statement Tuesday, Stealth said that “the U.S. Food and Drug Administration (FDA) communicated that it would not meet today’s prescription drug user fee action (PDUFA) date for its new drug application.”
Are the delays due to specific issues related to the drug? The answer seems to be no.
Typically, the FDA does not miss PDUFA dates unless it requests more data or raises safety or manufacturing concerns. Those sorts of delays are usually communicated to the companies with new decision dates.
The apparent delay comes in the middle of a period of huge upheaval across FDA and other US health agencies under Robert F. Kennedy Jr. The new HHS secretary and Elon Musk’s DOGE have fired thousands of staffers from the FDA, ousted CBER Director Peter Marks, and are looking at consolidating offices across the agency.
And more delays are likely coming:
One current FDA employee who requested anonymity previously confirmed to Endpoints that “hundreds” of drug and device reviewers have recused themselves to look for new jobs. Former FDA Commissioner Scott Gottlieb made similar comments in a CNBC interview last week.
Stay tuned to see if this is a one-off delay or part of a general trend.
