Health Secretary Robert F. Kennedy Jr. touts accelerated FDA oncology approvals under a new expedited review program, but researchers and former regulators say the comparisons may overstate the administration’s achievement.
In recent months, the Food and Drug Administration has approved a small number of drugs quite quickly under a new expedited review program. But Health and Human Services Secretary Robert F. Kennedy Jr. has overstated the program's impact by making misleading comparisons to past drug approval rates.
“We just approved two new drugs, two new oncology drugs, in record time, one in 45 days,” Kennedy said at an April 16 congressional hearing, adding that the other was approved in 55 days. “The closest before that was 310 days.” At another hearing that same day, he called the two approvals the “fastest in history.”
The cancer drugs weren’t entirely new. Instead, the FDA approved an expanded use, or indication, for a previously approved drug and a new combination of previously approved drugs, reviewing the drugs 44 and 55 days after filing, according to FDA news releases. Meanwhile, Kennedy’s 310-day figure is the average new drug application review time for 2025, according to remarks on April 1 by now-former FDA Commissioner Dr. Marty Makary.
