Premier Responds to RFI on Deregulation of HHS/FDA-Related Policies
In response to a request for information from HHS and the FDA, Premier submitted recommendations on regulations that should be rescinded or replaced because they have limited clinical benefits or are not well-suited to support coordinated, patient-centered care. Specifically, Premier urged the FDA to:
Collaborate with Congress to eliminate the biosimilar interchangeability pathway, and in the interim streamline biosimilar approval by enabling simultaneous biosimilarity and interchangeability designation, expedite review processes, clarify interchangeability guidance, and align naming conventions with international standards.
Optimize FDA’s regulations for pharmaceutical product review and approval.
Fully implement existing requirements under the CARES Act to address drug shortages before establishing new programs like Quality Management Maturity (QMM), which currently lacks operational clarity and risks unintended consequences.
Leverage artificial intelligence (AI) in clinical trials and drug manufacturing processes to streamline patient identification, enable synthetic data and control arms, enhance supply chain forecasting, optimize process control, and improve quality monitoring.
Streamline and clarify certain regulatory requirements to accelerate the use of new technology in clinical trials to foster innovation, while safeguarding data privacy and ethical standards.
