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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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. …
Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes. The appeal processes in both CDER and CDRH offer numerous strategic and procedural advantages that, when used …
The American Conference Institute will be holding its FDA Boot Camp conference in New York City from Tuesday, March 20 to Wednesday, March 21, 2012. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be …
