FDA Orphan Drug Requests Could Start To Rely More On Non-Profitability Criteria
This article was originally published in RPM Report
The Food & Drug Administration may start to see more requests for orphan drug designation based on a little-used criterion under the Orphan Drug Act: a drug that is not expected to recoup the development costs before the end of the seven-year exclusivity period.
You may also be interested in...
US FDA could revoke orphan designation or exclusivity if cost recovery requirements were not satisfied under bill unanimously passed by the House Energy and Commerce Committee.
In first-of-its-kind decision, agency concludes it relied on unreasonable assumptions regarding total market size, and failed to consider information about other dosage formulations, in granting designation for buprenorphine under the cost recovery provision; however, the FDA reaffirms that scope of Sublocade’s three-year exclusivity will keep Braeburn’s Brixadi off the market for another year.
Former FDA principal deputy commissioner Amy Abernethy says cell and gene therapy is an area primed for improved ‘parallel conversation’ between FDA and CMS on data requirements.