FDA issues guidance on cost recovery in clinical trials 

USA – The US Food and Drug Administration (FDA) has released a comprehensive guidance outlining the process for pharmaceutical companies to recover costs associated with investigational drugs used in clinical trials.  

This guidance, replacing the previous version issued in June 2016, delineates the eligibility criteria and logistics for sponsors seeking to charge trial participants for access to investigational drugs under an investigational new drug application (IND). 

The updated guidance addresses concerns surrounding the financial burden on participants while ensuring the integrity of clinical trials, particularly in blinded and controlled settings.  

Sponsors urged to collaborate with FDA  

Meanwhile, sponsors have been advised to collaborate closely with the appropriate FDA review division, such as the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER), to maintain trial blind integrity. 

Under the FDA’s regulations, sponsors may charge for investigational drugs in expanded access programs, provided they demonstrate that such charges do not impede drug development. 

 Sponsors must justify the necessity of cost recovery, especially in cases of extraordinary drug costs attributed to factors like manufacturing complexity or resource scarcity. 

 The FDA evaluates the “extraordinary” status of these costs relative to the sponsor’s financial position. 

Each month, the FDA reviews numerous investigational new drug applications to facilitate clinical research. Recent approvals include Veru’s Phase IIb trial for Ostarine, a drug targeting GLP-1 RA-associated muscle loss, and Acepodia’s solid tumor trial. 

 Additionally, the FDA offers a pre-IND consultation program, allowing sponsors to address any queries or concerns regarding the IND process directly with the agency. 

This guidance serves as a crucial resource for sponsors navigating the complex landscape of clinical trial regulations, ensuring transparency, compliance, and equitable access to investigational drugs for participants while advancing medical research and innovation.