OMB Reviews FDA Peptide Rule Amid Agency Staffing Concerns
What happened
The Office of Management and Budget is reviewing a proposed rule regarding peptides by the Food and Drug Administration. Meanwhile, some staff at the Department of Health & Human Services are concerned that a new performance assessment requirement may be part of reduction-in-force efforts. Former FDA Commissioners Robert Califf and Scott Gottlieb also criticized the Trump administration's reduction-in-force efforts through the Department of Government Efficiency last year.
From raps.org
Why it matters
The OMB review of the peptide rule could affect drug development costs and market access for pharmaceutical companies. Additionally, criticisms regarding agency staffing cuts suggest that medical product companies might have to deal with less experienced reviewers, potentially impacting regulatory timelines.
From raps.org
Who's involved
- Office of Management and BudgetAgency reviewing the proposed FDA peptide rule and overseeing agency actions.
- FDARegulatory agency whose peptide rules are under review by the OMB.
- Heidi OvertonPolicy advisor appointed to the formal leadership role of the FDA Commissioner.
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- PfizerSpeculative
The review of the peptide rule could affect Pfizer's drug development costs and market access.
Keep exploring
The entities involved
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FDA
- TraceLink advances multinational compliance roadmaps in Egypt and Ethiopia while addressing FDA's transition to 12-digit National Drug Code.
- Hemogenyx Pharmaceuticals Plc submitted an IND application for its HG-CT-1 therapy with the FDA and is building infrastructure for early commercialization in Europe.
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Office of Management and Budget
agency that prepares and evaluates the President of the United States' annual budget to Congress
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Heidi Overton
American policy advisor
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