By Kurt R. Karst – A few months have passed since the appeals Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”) filed with the U.S. Court of Appeals for the District of Columbia Circuit after …
By Kurt R. Karst – Congress has been busy in the lead-up to the holiday! In addition to the recently-enacted 2016 Consolidated Appropriations Act, which saddles FDA will meeting myriad requests and new requirements, a host of lawmakers from the U.S. House or Representatives recently sent …
The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 27th iteration, is slated to take place at The Carlton Hotel in New York, New York from March 9-11, 2016. The conference is billed as the premier event to provide folks with a …
By Kurt R. Karst – Here’s something you don’t often see: FDA initiating procedures to suspend the approval of an ANDA because of an Agency determination that the Reference Listed Drug (“RLD”) was withdrawn for what the Agency determined were safety or effectiveness reasons. But on …
By Kurt R. Karst – Last Wednesday, November 25, 2015, after a long slog through the legislative process (see our previous post here), President Obama signed into law the Improving Regulatory Transparency for New Medical Therapies Act (H.R.639). (Unlike other bills, H.R.639 doesn’t have a sexy …
By Kurt R. Karst – There are several important dates in the history of the Orange Book – FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations – some of which are the result of advancements in technology, and some of which occur (curiously) around the end …
By Kurt R. Karst – Earlier this week FDA finally released its Manual of Policies and Procedures (“MAPP”) on NDA Classification Codes (MAPP 5018.2) – formerly called “Chemistry Classification Codes.” The MAPP has been under development for quite some time . . . . and there’s …
By Kurt R. Karst – Hatch-Waxman Patent Term Extension (“PTE”) disputes never get old for this blogger. There’s often some new twist for FDA or the U.S. Patent and Trademark Office (“PTO”) to consider, as shown in a recent PTE denial for a patent concerning the …
By Kurt R. Karst – Predicting the future is a tricky business. Predictions don’t often pan out, even when most or all of the indicators prognosticators use say something will (or will not) happen. We have a pretty decent track record of guessing how a case …
By Kurt R. Karst – Hatch-Waxman controversies are often like trains barreling down railroad tracks. They first appear in the distance as small objects, seemingly moving at a slow velocity. But with each passing moment, the object grows larger and more distinct, and appears to pick …
By Kurt R. Karst – On September 30, 2015, Judge Randolph D. Moss of the U.S. District Court for the District of Columbia issued his highly-anticipated decision in a lawsuit lodged by Eisai Inc. (“Eisai”) last August challenging FDA's April 2014 denial of a Citizen Petition (Docket No. FDA-2013-P-0884) requesting that the Agency conclude that the …
By Kurt R. Karst – FDA recently released the Agency’s Seventh Annual Report to Congress, required by FDC Act § 505(q)(3), on FDA’s experience during Fiscal Year 2014 (“FY 2014”) with citizen petitions subject to FDC Act § 505(q). Other than some updated numbers fo FY …
By Kurt R. Karst – Finding new ways to incentivize and reward drug development for particular therapeutic needs is all the rage these days. Over the past few years we’ve seen several new incentives incorporated (and proposed for incorporation) into the FDC Act. These new incentives …
By Kurt R. Karst – Last week, Senators Amy Klobuchar (D-MN) and Charles Grassley (R-IA) announced the introduction of S. 2019, the Preserve Access to Affordable Generics Act. The bill is the latest attempt to pass legislation to address pharmaceutical patent settlement agreements (aka “reverse payment …
By Kurt R. Karst – It’s been a while since we peeked in on the appeals Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”) filed with the U.S. Court of Appeals for the District of Columbia …
