Lessons From Aduhelm: Don’t Go Over Your FDA Review Team’s Head, Pazdur Says
US FDA’s oncology chief says he won’t talk to sponsors unilaterally when a company takes issue with their review division. Pazdur also weighed in on his long-term career plans and his views on the FDA-industry revolving door at two ASCO interviews.
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Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval
June 7 marks the one-year anniversary of the accelerated approval of Biogen’s aducanumab, an event that still reverberates throughout the drug development community. While the FDA continues to defend the approval, experts say the backlash has caused the agency to become more reluctant to use the expedited pathway. Meanwhile, Alzheimer’s patients find themselves where they were a year ago: without ready access to a disease-modifying therapy.
Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.
US FDA’s Oncology Center of Excellence Director and the National Institutes of Health National Cancer Institute Director defended the agency’s accelerated approval pathway, saying critics are missing the benefits reaped by many cancer patients. Pazdur worries pathway is at risk, unless champions work to counter critics.