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US FDA's Major ORA Reorganization Plan Puts Centers In Charge Of Complaint Handling

 
• By Bowman Cox

Agency proposal, now under HHS review,  further reduces chances of losing another whistleblower complaint by taking ORA out of the loop, while proposing a new name for its slimmed-down field organization: Office of Inspections and Investigations. Meanwhile, an agency veteran, Michael Rogers, will lead the revamped organization as associate commissioner.

Complaints
no more complaints for ora/oii • Source: Shutterstock

A major reorganization that the Food and Drug Administration proposed 13 December for departmental review includes a new change stripping complaint-handling responsibilities from the agency’s field organization, the Office of Regulatory Affairs.

Sparked by a lost whistleblower complaint, the revamping of the agency’s Human Foods Program and field operation makes both the food program and the agency’s product centers (such as the Center for Drug Evaluation and Research) responsible for receipt, triage and closing of consumer and whistleblower complaints. The centers and field offices have been sharing this responsibility

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More from US FDA

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

More from Agency Leadership

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.