US Orphan Drug Act
- PMID: 37160304
- DOI: 10.1136/bmj.p928
US Orphan Drug Act
Conflict of interest statement
Competing interests: The BMJ has judged that there are no disqualifying financial ties to commercial companies. The author declares the following other interests: JSR currently receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from Arnold Ventures; in addition, JSR was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc that was settled September 2022; he is also an associate research editor for the BMJ. Further details of The BMJ policy on financial interests are here: https://www.bmj.com/sites/default/files/attachments/resources/2016/03/16-current-bmj-education-coi-form.pdf.
Comment on
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FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis.BMJ. 2023 May 9;381:e073242. doi: 10.1136/bmj-2022-073242. BMJ. 2023. PMID: 37160306 Free PMC article.
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