More than one-fifth of drugs recently approved by the US Food and Drug Administration (FDA) were not approved or recommended for public reimbursement in other countries, according to a recent study published in JAMA Internal Medicine.
“This cross-sectional study demonstrated that more than one-fifth of the new drugs approved by the FDA in 2017 through 2020 were either refused marketing authorization or not recommended for reimbursement in Australia, Canada, or the UK as of May 2022 due to unfavorable benefit-to-risk profiles, uncertain clinical benefit, or unacceptably high price,” Catherine Pham, PharmD, MPH, of the Pharmacy Outcomes Research Group at Kaiser Permanente National Pharmacy in Downey, CA, and colleagues wrote in their study.
“Most of the drugs refused marketing authorization or not recommended for public reimbursement internationally were initially approved by the FDA under the Orphan Drug Act or at least 1 expedited regulatory pathway,” they said…
