By Kurt R. Karst – A couple of weeks ago we announced a massive and unprecedented undertaking by FDA’s Office of Generic Drugs (“OGD”) to address an outpouring of concern about, among other things, a Manual of Policies and Procedures (“MAPP”) – MAPP 5200.3 – titled “Responding …
By Kurt R. Karst – The Electronic Age has changed nearly every aspect of our daily lives, and the day-to-day operations of the U.S. Federal Government are no different. The government is no longer open for business from 9-5, but rather 24 hours a day by …
By William T. Koustas – The litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA may have come to an end on Tuesday, February 4th, when the United States Court of Appeals for the District of Columbia Circuit ruled against Regenerative, concluding that FDA has the authority …
By Kurt R. Karst – The Wachowski Brothers’ Matrix Trilogy of movies depict a post-apocalyptic world in which reality is not what it seems. The reality most people perceive is actually a simulated reality created by sentient machines – a dream world created by virtue of …
By Kurt R. Karst – In a new paper published by The Petrie-Flom Center for Health Law Policy, BioTechnology, and BioEthics at Harvard Law School, and presented at a February 3, 2014 Health Law Workshop, Kevin Outterson, a Professor of Law at Boston University and member …
By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) has finally issued a final decision in the long-running dispute over eligibility for a Patent Term Extension (“PTE”) for U.S. Patent No. 5,674,860 (“the ‘860 patent”) covering AstraZeneca LP’s SYMBICORT (budesonide and formoterol fumarate …
By Kurt R. Karst – FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) and adherence to the triad of key aims laid out in the accompanying Performance Goals and Procedures – Safety, Access, and Transparency – have been a bit of a …
Biosimilars (or follow-on biologics) are a hot topic these days – and getting hotter – whether one talks about FDA’s draft guidance documents (see here), battles brewing in state legislatures around the country concerning substitution (see here), the flurry of citizen petitions submitted to FDA …
By Kurt R. Karst – In a Januarry 22, 2014 letter to FDA Commissioner Margaret Hamburg, M.D. signed by 28 members of Congress, lawmakers express “grave concerns” about FDA’s November 2013 proposed rule to allow generic drug manufacturers to independently update product labeling (with respect to …
By Kurt R. Karst – In a notice that will appear in the Federal Register later this week, FDA is announcing the establishment of a public docket (Docket No. FDA-2014-N-0032) to receive input and suggestions on ways to improve the quality of ANDAs (original, amendments, and …
By Jeffrey N. Wasserstein & Delia A. Stubbs – For years, those of us who followed FDA’s attempt to provide guidance related to social media felt like Vladimir and Estragon from Samuel Beckett’s Waiting for Godot. FDA initially promised guidance by the end of 2010. But, …
By Kurt R. Karst – It’s been quite some time since FDA established a public docket soliciting comment on an ANDA approval/Hatch-Waxman issue. But FDA revived the process earlier this week when the Agency issued a “Dear NDA/ANDA Applicant” letter (Docket No. FDA-2014-N-0087) concerning approval of …
By Kurt R. Karst – So much of what we do and think about each day inevitably leads us back to one topic: Hatch-Waxman. Take, for example, Polar Vortex 2014. That recent event got us thinking about two things: Snowmageddon 2011, and how warm we hope …
By Kurt R. Karst – With primary briefing over (briefs here, here, and here), and a December 13, 2013 Oral Argument before Judges Griffith, Kavanaugh and Randolph concluded, we were waiting with bated breath for the U.S. Court of Appeals for the District of Columbia Circuit …
By Karla L. Palmer – FDA Commissioner Margaret A. Hamburg, M.D., sent open letters (here and here) to “Hospital Purchasers” and state officials including governors, state boards of pharmacy and health departments, informing them of the passage of the Drug Quality and Security Act (Public Law 113-54,127 …
