Generic industry urges FDA to expand inspections as rehiring begins
Industry groups welcome the FDA’s move to rehire key Office of Generic Drugs staff and call for more inspection capacity to ease backlogs and support market supply.
Date: August 25, 2025
Summary
Generic drug industry representatives welcomed the US Food and Drug Administration’s rehiring of staff in the Office of Generic Drugs (OGD) after a recent reduction in force. They are asking the agency to expand both domestic and foreign inspections, noting that inspection volume has not returned to pre-COVID-19 levels. They also want OGD policy staff focused on product-specific guidances to address backlogs that affect generic development.
What happened
- The FDA began rehiring key employees in OGD and related support roles following a reduction in force imposed on April 1 and finalized on July 14, which resulted in the loss of about 600 staff from the Center for Drug Evaluation and Research.
- At a House Energy and Commerce Health Subcommittee hearing, the Association for Accessible Medicines (AAM) said rehiring should help increase the pace of inspections.
- AAM noted inspection volume still has not reached pre-COVID-19 levels and called for funding to maintain a fully functional inspection force.
- The FDA asked OGD policy staff who were affected by the reduction to return in June, with the goal of resuming work on product-specific guidances (PSGs) for potential generics.
Why it matters
- Inspections enable market entry: Inspection capacity is critical for bringing products to market and maintaining a reliable supply of medicines.
- Backlogs affect affordability: Delays in PSG development slow generic pathways, which can delay access to lower-cost options.
- Stability across the supply chain: More inspection capacity, including overseas, supports a stable flow of medicines to patients.
Inspection program updates
- A May Executive Order directed the FDA to streamline domestic site inspections and strengthen unannounced foreign inspections.
- AAM indicated it looks forward to working with the agency to expand inspections domestically and overseas.
Product-specific guidances (PSGs)
- Industry is watching for a restart of PSG issuance after earlier delays.
- AAM reported that some delays this year hindered manufacturers from requesting PSGs, but activity appears to be coming back online.
- The FDA released its first batch of PSGs during the second Trump Administration on May 20.
Key numbers and dates
- ~600 staff lost from CDER due to the reduction in force.
- April 1: Reduction in force imposed.
- June: OGD policy staff asked to return.
- July 14: Reduction in force finalized.
- May: Executive Order on inspections.
- May 20: First batch of PSGs released during the second Trump Administration.
What to watch next
- Whether inspection volumes increase toward or beyond pre-COVID-19 levels.
- Progress on reducing the PSG backlog and issuing new guidance.
- Funding decisions that affect FDA inspection capacity.
Source: Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff
