While the FDA was hit with staffing and budget cuts this year, the agency managed to increase its inspection and enforcement activities.
Despite significant budget and headcount reductions at the U.S Food and Drug Administration (FDA), the agency launched several initiatives this year meant to streamline regulations and support transparency, while boosting its enforcement activities against pharmaceutical manufacturers — both foreign and domestic.
In 2025, the FDA expanded its use of unannounced inspections at foreign manufacturing facilities, particularly in countries such as China and India which disproportionately supply active pharmaceutical ingredients to the U.S. market. In May, the agency announced that going forward foreign companies would not continue to enjoy the “double standard” previously afforded to them — with advanced notices before facility inspections — and would now be subject to the same oversight and scrutiny as American manufacturers.
This year, the FDA significantly increased its issuance of warning letters. Between July 1 and Dec. 3, the agency issued 327 warning letters — a 73% increase over the same period in 2024. Last month, a high-profile warning letter was issued to Novo Nordisk regarding a former Catalent site in Bloomington, Indiana, acquired last year by the Danish drugmaker. Among the cGMP violations, the FDA’s warning letter called out Novo Nordisk’s inadequate investigations into drug product failures and discrepancies.
On the policy front, a new program was launched in August — called FDA PreCheck — meant to provide drug manufacturers with earlier and more frequent interaction with the regulator on manufacturing facility design and construction. The goal is to accelerate the pharma industry’s efforts to expand U.S. manufacturing operations by increasing regulatory predictability and coordination with biopharma companies.
Although the Trump administration has made the onshoring of manufacturing a priority, critics contend that by gutting the FDA it has undermined the regulatory and scientific infrastructure needed to strengthen the U.S. They warn that workforce disruptions and tariff-driven price increases on essential equipment could undercut onshoring goals as well as the FDA’s essential functions — particularly when it comes to site inspections and reviews for product approvals.
Uncertainty at the FDA will no doubt continue to weigh on the biopharma sector heading into 2026.
Continue at: https://www.pharmamanufacturing.com/compliance/article/55340503/top-7-pharma-manufacturing-regulatory-stories-of-2025
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