More commentary from BP, issued 05/05/2025 in their "Biotechnology - Drug Developers Q3 FY25 Review"
They report that the appointment of Marty Makary as FDA Commissioner provides optimism. BP considers Makary to be a relatively pragmatic Commissioner and they welcome this degree of regulatory stability.
Although the FDA cut about 3,500 staff out of about 18,000, Makary commented encouragingly. He noted that the cuts were to communication, lobbyist and IT staff and not to scientists, reviewers or inspectors. This is consistent with reports from ASX companies that FDA engagements in recent months have been conducted in accordance with agreed timelines. A few US companies have reported delays.
Makary also reported improvement in FDA's postmarketing surveillance capabilities to reduce pre-approval clinical trial requirements in certain instances, particularly in very rare diseases via a new approval pathway for drugs with a scientifically “plausible mechanism”.
Also, removing animal testing requirements to reduce preclinical requirements to be more in line with other agencies.
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