Article Summary:
FDA Commissioner Marty Makary recently touted his first 100 days leading the agency, highlighting actions to encourage food manufacturers to remove petroleum-based dyes, reduce animal testing, and establish a new program to expedite reviews of drugs addressing significant public health needs. Makary has made media appearances to provide more details on this “Commissioner’s National Priority Voucher” initiative, which aims to speed up approvals for drugs that address national priorities like affordability and domestic manufacturing.
Makary has also criticized the agency’s multiple adverse event reporting systems, pledging to consolidate them into a single, user-friendly platform. He has championed the FDA’s new policy of publicly releasing complete response letters detailing why drug applications were rejected, in the interest of greater transparency.
Meanwhile, the Senate Appropriations Committee has advanced a $7 billion budget for the FDA in fiscal year 2026, while the House is considering a slightly lower figure. Upcoming FDA meetings will focus on user fee programs for generic drugs, biosimilars, and over-the-counter drugs.
Notable regulatory actions include the approval of KalVista’s oral treatment for hereditary angioedema, and recalls issued for certain ventilation products due to potential safety issues. The text also touches on the Biden administration’s federal hiring freeze, though Makary has assured FDA staff that hundreds of job openings remain at the agency.
Overall, the summary highlights Makary’s early initiatives, the agency’s budget and policy deliberations, and specific drug and device regulatory developments under the new FDA leadership.