Docket for K-V v. FDA appeal, including deadlines

Court of Appeals Docket #: 12-5349 Docketed: 11/08/2012 Nature of Suit: 2890 Other Statutory Actions K-V Pharmaceutical Company, et al v. FDA, et al Appeal From: United States District Court for the District of Columbia Fee Status: Fee Paid

Case Type Information: 1) Civil US 2) United States 3)

Originating Court Information: District: 0090-1 : 1:12-cv-01105-ABJ Lead: 1:12-cv-01105-ABJ Motions Judge: Amy Berman Jackson, U.S. District Judge Date Filed: 07/05/2012 Date Order/Judgment: Date NOA Filed: 09/06/2012 11/02/2012

11/08/2012 US CIVIL CASE docketed. [12-5349] 11/08/2012 NOTICE OF APPEAL filed [1403832] by K-V Pharmaceutical Company and Ther-RX Corporation seeking review of a decision by the U.S. District Court in 1:12-cv-01105-ABJ. Assigned USCA Case Number [12-5349] 11/08/2012 CLERK'S ORDER filed [1403839] directing party to file initial submissions: APPELLANT docketing statement due 12/10/2012. APPELLANT certificate as to parties, etc. due 12/10/2012. APPELLANT statement of issues due 12/10/2012. APPELLANT underlying decision due 12/10/2012. APPELLANT deferred appendix statement due 12/10/2012. APPELLANT notice of appearance due 12/10/2012. APPELLANT transcript status report due 12/10/2012. APPELLANT procedural motions due 12/10/2012. APPELLANT dispositive motions due 12/24/2012; directing party to file initial submissions: APPELLEE certificate as to parties, etc. due 12/10/2012. APPELLEE entry of appearance due 12/10/2012. APPELLEE procedural motions due 12/10/2012. APPELLEE dispositive motions due 12/24/2012 [12-5349]

The Makena Story

Michelle Oxman has written a blog entry entitled, What Does the Makena Story Tell Us About the Orphan Drug Act?, (September 24, 2012).  The article deals with why prescription drugs are a large portion of health care spending.  The article does a good job of explain the  Orphan Drug Act (ODA) (P.L. 97-414)  and of discussing the K-V v. FDA decision.  To read this article click here.

DC Court has Issued Opinion in K-V v. FDA case

To view the decision click here