By Kurt R. Karst – In music, “coda” is a term used primarily to designate a passage that brings a piece (or a movement, which may be part of a symphony – an extended musical composition) to an end – the “fine.” A coda can be …
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Hyman Phelps McNamara
- The Coda in the ANGIOMAX Symphony; Approaching Fine (the End)February 9th, 2012
- The Year of the Orphan; Orphan Drug Designations and Approvals Hit All-Time High in 2011February 8th, 2012
By Kurt R. Karst – It’s about that time of year again when we do some number crunching and take stock of the year that was in orphan drug designations and approvals. And what a year it was! FDA not only approved a record 26 marketing …
- DC District Court Grants FDA Summary Judgment in Generic LOVENOX DisputeFebruary 7th, 2012
By Kurt R. Karst – On February 7, 2012, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia issued her decision in the long-running dispute concerning FDA’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 077857 for a generic version …
- Senators Casey and McCain Introduce Bill to Streamline De Novo Process and Reclassify Preamendment DevicesFebruary 6th, 2012
By Jennifer D. Newberger – On Thursday, February 2, Senators Bob Casey (D-PA) and John McCain (R-AZ) introduced S. 2067, titled the “Safe, Efficient, and Transparent Medical Device Approval Act” or the “SET Device Act.” The bill would require FDA to reclassify preamendment Class III devices …
- CMS Publishes Proposed Rewrite of Medicaid Drug Rebate Program Regulation; HP&M Issues SummaryFebruary 5th, 2012
By Alan M. Kirschenbaum & Michelle L. Butler - A long anticipated proposed revision to CMS regulations governing the Medicaid Drug Rebate Program ("MDRP") appeared in the Federal Register on Thursday, February 2, 2012. As expected, the proposal implements amendments to the MDRP that were enacted …
- Drug Shortage Prevention Act Seeks to Improve Communication and Expedite Review of Drugs in ShortageFebruary 3rd, 2012
By Kurt R. Karst – Earlier this week, Representatives John Carney (D-DE) and Larry Bucshon (R-IN) introduced H.R.3839, the “Drug Shortage Prevention Act,” which, according to its sponsors, is intended to bring “more efficiency to the manufacturing and distribution processes” and to require “FDA to …
- A Solution in Search of a Problem: Safety of Untested and New Devices Act of 2012February 1st, 2012
By Jennifer D. Newberger – On January 31, 2012, Rep. Edward Markey (D-MA) introduced H.R. 3847, the “Safety of Untested and New Devices Act of 2012,” also known as the “SOUND Devices Act of 2012.” The bill attempts to limit the body of devices that may …
- GAO Report Criticizes FDA on Antibiotic Labeling; Finds No Evidence of Encouraged InnovationFebruary 1st, 2012
By Kurt R. Karst – A new report released by the Government Accountability Office (“GAO”), titled “Antibiotics: FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information,” says that since the September 27, 2007 enactment of the FDA Amendments Act (“FDAAA”) FDA has …
- PTO Challenged After Denying a Patent Term Extension Based on First Commercial Marketing or Use GroundsJanuary 31st, 2012
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) has been sued once again after denying a Patent Term Extension (“PTE”) request. The latest case in a long line of lawsuits concerns U.S. Patent No. 5,206,248 (“the ‘248 patent”), which is listed in …
- CDRH Issues its Strategic Priorities for 2012January 29th, 2012
By Jennifer D. Newberger – On Tuesday, January 24, FDA’s Center for Devices and Radiological Health (“CDRH”) released its strategic priorities for 2012: (1) fully implement a total life cycle approach; (2) enhance communication and transparency; (3) strengthen the CDRH workforce and workplace; and (4) proactively …
- Supreme Court Rules Federal Meat Inspection Act Preempts California’s Ban on Slaughter of Non-Ambulatory AnimalsJanuary 26th, 2012
By Riëtte van Laack – On Monday, January 23, 2012, the U.S. Supreme Court ruled that a California state law prohibiting the slaughter, processing, and sale of any non-ambulatory animals is preempted by the Federal Meat Inspection Act (“FMIA”). As we previously reported, under California's Downed Animal …
- GAO Recommends Coordination and Assessment of Federal Efforts to Educate About Prescription Pain Reliever Abuse and MisuseJanuary 25th, 2012
By John A. Gilbert, Jr. & Larry K. Houck – The Government Accountability Office (“GAO”) has issued a report focusing on federal agency efforts to educate prescribers and the public about prescription pain reliever abuse and misuse. The report’s title, “Prescription Pain Reliever Abuse: Agencies have …
- A New Hatch-Waxman DJ Jurisdiction Decision . . . . And an Added TwistJanuary 24th, 2012
By Kurt R. Karst – In a recent Hatch-Waxman decision from the U.S. District Court for the Northern District of Illinois (Eastern Division), the court denied Plaintiffs’ Seattle Children’s Hospital, Novartis Vaccines and Diagnostics, Inc., and Novartis Pharmaceuticals Corporation (collectively “Novartis”) Motion to Dismiss the lawsuit …
- Leap Year and Hatch-Waxman – An Unusual Conundrum Years in the MakingJanuary 23rd, 2012
By Kurt R. Karst – It’s absolutely amazing how, after nearly 28 years, the 1984 Hatch-Waxman Amendments continue to provide surprises. Consider the latest example we came upon recently (with a little help) involving PRISTIQ (desvenlafaxine) Extended-Release Tablets. FDA approved PRISTIQ under NDA No. 021992 in a …
- Congressional Representatives Press FDA For Action on Third-Party AuditsJanuary 23rd, 2012
By Ricardo Carvajal – In tandem with the release of a House Energy and Commerce Committee staff report on last year’s outbreak of Listeria monocytogenes in cantaloupe, members of that committee sent Commissioner Hamburg a letter calling for reforms in the conduct and oversight of third-party audits. …