Prescription Drugs and Biologics

By Kurt R. Karst –       Those of us who work in the drug approval world know that a high degree of coordination among various FDA components is necessary for a smooth and efficient approval process.  This is particularly true for ANDA generic drug …

By Kurt R. Karst –       The question was not whether, but when, FDA would be sued over a decision involving 180-day generic drug exclusivity and the so-called “failure to obtain timely tentative approval” forfeiture provision at FDC Act § 505(j)(5)(D)(i)(IV).  That day has finally come.  …

By Kurt R. Karst –       Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourge the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing …

By Alexander J. Varond – On September 25, 2012, the President’s Council of Advisors on Science and Technology (“PCAST”) released a report entitled “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.”  PCAST is a commission of leading scientists and engineers who …

By Kurt R. Karst –        Public turmoil over FDA decisions involving orphan drug exclusivity has been relatively rare in recent years.  That has changed over the past several months.  First there was the lawsuit brough against FDA by K-V Pharmaceutical Company to “restore” …

By Kurt R. Karst –       Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (“GDUFA”) is expected to be introduced this week (and perhaps voted on by both the U.S. House of Representatives and the U.S. Senate).  …

By Kurt R. Karst –       In our recent post, “Hot Ticket Item – Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning patent settlement agreements (or “pay-for-delay” agreements if you prefer that term – we don’t).  It’s …

By Kurt R. Karst –       While Congress and The White House debate whether user fees paid pursuant to various UFAs – User Fee Acts – will be sequestered under the terms of the Budget Control Act (see here), FDA continues to move forward with planning …

By Kurt R. Karst –    In the world of Hatch-Waxman, disputes over 180-day generic drug exclusivity have been commonplace for well over a decade now.  Indeed, in 2012 alone there have already been a few lawsuits filed against FDA concerning generic ACTOS and generic PROVIGIL …

By Kurt R. Karst –       In a decision handed down late in the day on Thursday, September 6th, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia dealt a blow to K-V Pharmaceutical Company’s (“KV’s”) efforts to “restore” orphan drug …

By Kurt R. Karst –       As we patiently await FDA’s next annual report to Congress on 505(q) citizen petitions (see our previous posts on FDA’s annual reports here, here, and here) we thought we would take a minute to share with our readers some observations …

By Kurt R. Karst –       One recent afternoon we returned to our office from a meeting to find the new (2012) nine-volume set of Title 21 of the Code of Federal Regulations (“CFR”) placed on our desk chair.  There’s a special place on our desk …

By Kurt R. Karst –       It seems that hardly a day goes by without something new happening concerning patent settlement agreements.  They are generally referred to as “pay-for-delay” agreements; however, that’s a bit of a loaded term, and one we try to avoid.  We just …

By Alexander J. Varond – The Institute of Medicine (“IOM”) recently issued a paper titled “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary.” The IOM paper summarizes the “Maximizing the Goals of the Cures Acceleration Network to …

By Kurt R. Karst –       In a pair of Federal Register notices (here and here) set for publication on August 27, 2012, and in a pair of draft guidance documents released ahead of their announcement in the Federal Register next week (here and here), FDA …