By Kurt R. Karst – It was just yesterday that we commented on how folks in the Hatch-Waxman community have been patiently awaiting FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic …
By Kurt R. Karst – As folks in the Hatch-Waxman community patiently await FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic version of XYZAL (levocetirizine dihydrochloride) with skinny labeling that omits, via …
By Kurt R. Karst – Last week, substantively identical legislation was introduced in both the U.S. House of Representatives and in the U.S. Senate to amend the FDC Act to prohibit the manufacture, marketing, sale, or distribution of an authorized generic version of an NDA-approved drug …
By Kurt R. Karst – The tome that is the President’s Budget for Fiscal Year 2012 is chock-full of new proposals that, if implemented, would significantly affect both brand-name and generic drug manufacturers. What first caught our attention were some statements in an overview of the proposed …
By Kurt R. Karst – Late last year, Impax Laboratories, Inc. (“Impax”) filed a Complaint in the U.S. District Court for the District of New Jersey seeking a judgment with respect to U.S. Patent No. 6,911,217 (“the ‘217 patent”). The ‘217 patent is one of four …
By Susan J. Matthees – Six inmates on death row in three different states sued FDA in the U.S. District Court for the District of Columbia over the importation of thiopental sodium, one of the drugs used by some states to administer a lethal injection. The …
By Kurt R. Karst – The ANDA backlog in FDA’s Office of Generic Drugs (“OGD”) continued to grow unabated in 2010. OGD started out the year with a backlog of 1963 original applications and ended the year up almost 400 applications, for a grand total of …
In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Associate Peter M. Jaensch discusses the increasing use of the False Claims Act ("FCA") to privately prosecute what are actually violations of the FDC Act, and examines the allegations underlying the recent GlaxoSmithKline …
By Kurt R. Karst – FDA’s Office of Orphan Products Development (“OOPD”) was busy in 2010! According to recent data obtained by FDA Law Blog, after a banner year in 2009 in which OOPD surpassed the 2,000 orphan drug designation mark and designated a near-record 160 …
By Kurt R. Karst – Among the several FDA-related bills that have already been introduced in the 112th Congress – see our 112th Congress FDA Legislation Tracker – is Senator Herb Kohl’s (D-WI) Preserve Access to Affordable Generics Act (S. 27) concerning patent settlement agreements (or what …
By Kurt R. Karst – In yet another letter to FDA Commissioner Hamburg concerning the 12-year period of reference product exclusivity (which can be extended to 12.5 years with pediatric exclusivity) created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a bipartisan group …
By Kurt R. Karst – Yesterday, we posted on FDA’s report to Congress on encouraging the early submission of citizen petitions covered by FDC Act § 505(q). Today, we take a look at the two annual reports FDA has submitted to Congress detailing the Agency’s experience …
By Kurt R. Karst – On January 24th, the U.S. Court of Appeals for the Ninth Circuit issued its decision in Gaeta v. Perrigo, reversing a decision from the U.S. District Court for the Northern District of California (San Jose Division) that Plaintiff-Appellant Gaeta’s state law …
By Kurt R. Karst – Reports FDA submitted to Congress on the Agency’s implementation of FDC Act § 505(q) recently became available and show that only a few applications have been delayed by certain citizen petitions covered by the law, and that the Agency is timely …
On January 23rd, BioCentury This Week TV will broadcast a program concerning the latest thinking about how to create a sustainable economic model for both orphan drug developers and payers. The program, titled “The Economics of Orphan Drugs – Why Successful Cures Bring Challenges for …
