By Kurt R. Karst – Sometimes curiosity gets the better of us . . . . We take some bait and go down a rabbit hole. That’s what happened last week after FDA published a notice in the Federal Register announcing the Agency’s determination that Ondansetron …
By James E. Valentine* & Jay W. Cormier – On June 1, 2015, FDA announced the availability of a draft guidance for industry entitled “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.” The draft guidance is intended to address a “lack of clarity” …
By Kurt R. Karst – We thought FDA would be hauled into court after the Agency denied, on October 10, 2014, two Petitions for Reconsideration (here and here) asking the Agency to rethink a February 21, 2014 Consolidated Response Denial to three Citizen Petitions requesting that …
By Kurt R. Karst – It was just a few weeks ago that we noted in a post concerning FDA’s recently finalized guidance document on “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” that the Agency removed from the 2012 draft version of the document …
By Kurt R. Karst – Here we are . . . on the eve of Oral Argument before the U.S. Court of Appeals for the Federal Circuit in a dispute over the applicability and correct interpretation of various provisions of the the Biologics Price Competition and …
By Kurt R. Karst – [FDA’s] ultimate conclusion that Vascepa, a drug “no active ingredient of which . . . has been approved” in a previous NDA, was not entitled to exclusivity, is contrary to the statute’s plain meaning. Rather than explaining this discrepancy, the administrative …
By Kurt R. Karst – Like rapid gunfire (judicial style), two courts – the U.S. District Court for the District of Maryland and the U.S. District Court for the District of Columbia – issued decisions on May 27, 2015 within hours of one another denying challenges …
By Karla L. Palmer – Last week, Senator David Vitter (R-LA) introduced S. 1406, the Saving Access to Compounded Medications for Special Needs Patients Act, to amend Section 503A of the Federal Food, Drug, and Cosmetic Act. The amendment addresses confusion over a compounding pharmacy’s “distribution” of …
By Kurt R. Karst – On May 19th, the House Committee on Energy and Commerce took up consideration of the 21st Century Cures Act. The bill, H.R. 6, is a 309-page behemoth that was officially introduced on May 19th, and is the fourth iteration of the …
By Kurt R. Karst – Each month we pore over the latest Orange Book Cumulative Supplement in an effort to keep our popular 180-Day Exclusivity Tracker as current as possible, and to look for interesting precedents. Last month, one entry in particular caught our attention. It …
By James E. Valentine* & Alexander J. Varond – After giving us a few months to shake our sticks at the nearly 400-page 21st Century Cures Act (the Cures Act) discussion draft, the House Energy and Commerce Committee (the Committee) dropped a 200-page version that was …
By James E. Valentine* – In late April 2015, FDA’s Bioresearch Monitoring (“BIMO”) Program released its annual report on inspections from the previous fiscal year. BIMO is FDA’s multi-center compliance program for on-site inspections and data audits to monitor all aspects of FDA-regulated research, domestically and …
By James C. Shehan – On April 28th, FDA finalized the three biosimilar guidances that it issued in 2012. Covering the topics of questions and answers regarding BPCIA implementation, scientific considerations in demonstrating biosimilarity, and quality considerations in demonstrating biosimilarity of proteins to reference products, the …
By Kurt R. Karst – There’s no rest for the weary! There certainly hasn’t been much rest for FDA’s litigation team this past week . . . . and it’s not getting any better. The week started off quiet (though clearly anxiety was in the air), …
In a new guidebook published by the Food and Drug Law Institute, David B. Clissold and James E. Valentine of Hyman, Phelps & McNamara, P.C. co-authored Chapter 3-1, “FDA Regulatory Scheme,” and Alexander J. Varond authored Chapter 3-7, “Orphan Drugs.” Both chapters cover essential elements of …
