Pham et al. (2023) makes use of information on regulatory choices and well being know-how assessments (HTAs) in Australia, Canada, and the UK and compares them to the medicine which might be FDA-approved within the US. They discover that:
The FDA authorized 206 new medicine in 2017 via 2020, of which 162 (78.6%) have been granted advertising authorization by at the very least 1 different regulatory company at a median (IQR) delay of 12.1 (17.7) months following US approval. Conversely, 5 FDA-approved medicine have been refused advertising authorization by a world regulatory company on account of unfavorable benefit-to-risk assessments. An extra 42 FDA-approved medicine obtained unfavourable reimbursement suggestions from HTA companies in Australia, Canada, or the UK on account of uncertainty of medical advantages or unacceptably excessive costs. The median (IQR) US value of the 47 medicine refused authorization or not beneficial for reimbursement by a world company was $115 281 ($166 690) per affected person per yr. Twenty medicine have been for oncology indications, and 36 have been authorized by the FDA via expedited regulatory pathways or the Orphan Drug Act.
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