Compassionate use of experimental drugs involves physicians prescribing unapproved treatments for patients who don’t have any other satisfactory alternatives on the market.
The decision follows the FDA’s possible deferral of Serapta Therapeutic’s muscle-wasting drug eteplirsen after an advisory panel determined the treatment was not effective. As of now, no other treatments for Duchenne muscular dystrophy are on the market.
While the FDA will allow drug companies to charge for an unapproved drug, it cannot force government or private health insurers to pay for these drugs.
More articles on supply chain:
FDA issues final guidance over post-market surveillance for medical devices
These drug, device companies are offering money-back guarantees to hospitals, payers
Medical device sales drive Medtronic’s $1.1B net income in Q4
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.