Charging for IMPs? FDA has some Answers

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

The U.S. Food and Drug Administration (FDA) issued a revised Q&A document on charging for investigational medicinal products (IMPs). The draft guidance responds to frequently asked questions about FDA's processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances.  

Background

Since the FDA issued the guidance in June 2016, the agency has received questions from stakeholders related to implementation of the agency's regulation on charging for IMPs for the purpose of either clinical trials or expanded access for treatment use. FDA is providing the revised Q&A document to address the most recently asked questions and provide additional questions and answers. Significant changes to the 2016 version include additional recommendations related to the need for submission of a statement by an independent certified public accountant under certain circumstances, and distribution of the manufacturing, administrative, or monitoring costs from the first year over the expected duration of the expanded access IND or protocol. When finalized, the document will replace the 2016 final guidance.

Questions and Answers

The questions and answers are organized as follows:

• General Questions Related to Charging for Clinical Trials and Expanded Access Use (e.g., "Once FDA authorizes a request to charge, whom may the sponsor charge?"),
• Charging in Clinical Trials (e.g., "How long may a sponsor charge for an investigational drug in a clinical trial after FDA authorizes the charging?", "What is an independent certified public accountant?", "When a sponsor uses its own investigational drug in a clinical trial, what requirements must the sponsor satisfy to charge for the drug?"),
• Charging for Expanded Access Use (e.g., "What requirements must a sponsor satisfy to charge for expanded access use?" )
• Cost Recovery Calculations (e.g., "What information is a sponsor required to submit to support its cost calculation?").

More information is available in FDA´s draft guidance Charging for Investigational Drugs Under an IND: Questions and Answers.