By Kurt R. Karst – The drama in the decade-old fight over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) has taken yet another turn. The U.S. Court of Appeals for the Federal Circuit …
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 Ricardo Carvajal – Senator Patrick Leahy (D-VT) reintroduced legislation to strengthen criminal penalties for food safety violators in the form of the Food Safety Accountability Act of 2011. As with the version of the bill introduced last year, the current version would amend Title 18 …
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By Susan J. Matthees – FDA is withdrawing its draft guidance titled “Draft Guidance for Industry: Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010,” which was published in August 2010. As …
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 Ricardo Carvajal – When FDA issued a report on the Reportable Food Registry ("RFR") 7 months after the RFR’s implementation, the agency cautioned that it was “too early to draw inferences concerning patterns of food and feed adulteration.” Not so in the agency’s first annual …
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 …
By Ricardo Carvajal – The Government Accountability Office ("GAO") issued a report recommending in part that FDA “identify and request from Congress the authorities needed to access evidence from food companies regarding potentially false or misleading structure/function or other claims on food that would allow the …
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 …
By Kurt R. Karst – Following the submission of two letters to FDA from both members of the U.S. House of Representatives and the U.S. Senate (see our previous posts here and here) critical of the Agency’s recent characterization of the 12-year reference product exclusivity period …
