Spectrum Pharm., Inc. v. Burwell
| Docket Number | 15-5166 |
| Decision Date | 03 June 2016 |
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6 cases
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Eagle Pharm., Inc. v. Azar
...because the comparatively small demand for treatment left little motive for research and development."1 Spectrum Pharm., Inc. v. Burwell , 824 F.3d 1062, 1064 (D.C. Cir. 2016) (citing § 1(b)). The ODA’s goal is to "reduce the costs of developing" and "provide financial incentives to develop......
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Vanda Pharm. v. Ctrs. for Medicare & Medicaid Servs.
... VANDA PHARMACEUTICALS, INC., Plaintiff, v. CENTERS FOR MEDICARE & MEDICAID SERVICES, et al., Defendants. Civil Action No ... treat rare diseases. See Spectrum Pharm., Inc. v ... Burwell , 824 F.3d 1062, 1064 (D.C. Cir. 2016). One of ... those ... ...
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Eagle Pharms., Inc. v. Alex M. Azar II in His Official Capacity
...had deterred the development of drugs to treat rare diseases, often referred to as "orphan drugs." See Spectrum Pharm., Inc. v. Burwell, 824 F.3d 1062, 1064 (D.C. Cir. 2016); Genentech, Inc. v. Bowen, 676 F. Supp. 301, 302-03 (D.D.C. 1987). Accordingly, in 1983, Congress enacted the Orphan ......
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Catalyst Pharm., Inc. v. Becerra
...for which the orphan drug was designated pursuant to § 360bb.Fourth, the district court's reliance on Spectrum Pharmaceuticals, Inc. v. Burwell , 824 F.3d 1062 (D.C. Cir. 2016), and Sigma-Tau Pharmaceuticals, Inc. v. Schwetz , 288 F.3d 141 (4th Cir. 2002), in support of its finding of ambig......
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2 books & journal articles
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Off-label Innovations
...generic changes the proposed dosage to better match the use still subject to market exclusivity. See Spectrum Pharms., Inc. v. Burwell, 824 F.3d 1062, 1066, 1067-68 (D.C. Cir. 2016).146. The generic label must "carve out" any references to drugs currently under market exclusivity. 21 C.F.R.......
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BANNING OFF-LABEL DRUG PROMOTION OFFENDS THE U.S. CONSTITUTION: MAKING THE STRONGEST CASE.
...to strengthen risk information unilaterally), withdrawn, 83 Fed. Reg. 64,299 (Dec. 14, 2018). (17) See Spectrum Pharm., Inc. v. Burwell, 824 F.3d 1062, 1066 (D.C. Cir. 2016) ("FDA permits what is called a labeling 'carve-out' that allows producers to sell a generic if they exclude from its ......