Guidance on Charging for Unapproved Drugs Undergoes Update

Drug companies and researchers looking to charge for investigational medications at cost will have more direction from US regulators on how to submit their paperwork.

The Food and Drug Administration is updating existing guidance in response to some of the most common inquiries it’s received since publishing the document more than than six years ago. The guidance answers questions about when it’s OK to charge for unapproved drugs being tested in a clinical trial or offered through an expanded access protocol, which requires a clinician to request access from federal authorities.

Companies and other sponsors of investigational new drugs typically ...