Kurt R. Karst

FDA’s recent announcement (see our previous post here) that after 40 years the Orange Book may get a bit of a facelift – as well as a comment in a new draft guidance that folks could obtain prior editions of the Orange Book through the …

Much to our delight, the Orange Book is getting quite a bit of attention from FDA in 2020.  And why not?!?  After all, the Orange Book is celebrating its 40th anniversary this year.  There was even a special “BPCIA Orange Book Transition Edition” published in …

Hyman, Phelps & McNamara, P.C. is  pleased to announce that Sara Koblitz will be speaking in an upcoming Strafford live webinar, “Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation” scheduled for Thursday, February 13, 1:00pm-2:30pm EST. The panel will provide …

Earlier this week, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR) and Senate Health Committee Chairman Lamar Alexander (R-TN) announced that they reached agreement on a bipartisan, bicameral drug pricing bill, called The Lower Health Care Costs Act …

Does the U.S. legal system steer researchers away from drugs that take a long time to develop?  That’s the question asked and answered in a new research paper authored by our friend Erika Lietzan, Associate Professor of Law at the University of Missouri School of …

Fall is in the air.  We know that not only beacuse the kids are off to school and the Summer heat is tailing off, but because of the uptick in questions we field on a daily basis concerning user fees under both the Prescription Drug …

That quote from “the Dude” from one of the final scenes of the 1998 film The Big Lebowski sums up well where things stand—or should we say “cannot stand, man”—insofar as drug pricing legislation, and, in particular, the Bringing Low-cost Options and Competition while Keeping …

FDA’s interpretation and application of the Best Pharmaceuticals for Children Act (“BPCA”), which provides for a 6-month add-on period of pediatric exclusivity has piqued our interest more than once over the years, leading to several posts (see, e.g., here, here, and here).  We now have …

“Don’t test me!”— that’s a warning that I, along with my younger brother, Erik, heard more than once from our parents while growing up.  The warning would come up from time to time—but particularly during our teenage years—when teenagers do what they sometimes do: challenge …

Okay, okay . . . .  It’s now a month after Rare Disease Day (on which Hyman, Phelps & McNamara, P.C.’s own Frank J. Sasinowski took part in some of the festivities).  We’re a little late this year in pulling together and posting on the …

The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments.  For several years after the enactment of Hatch-Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.  And although …

Over the 12 years that we’ve been doing this blogging gig, we’ve never before drawn inspiration for a post from Lebowski Pony – a.k.a. “the Dude” – that iconic character from the 1998 film The Big Lebowski, written and directed by Joel and Ethan Coen. …

Waaaaayyyy back in 2012, when life (and practicing food and drug law) was simpler, something caused us to study and evaluate the year-over-year change (i.e., the change in girth by the number of pages) in Title 21 of the Code of Federal Regulations (“CFR”) from …

Please clear your mind of any premature thoughts and allusions that are untoward or prurient in nature. The title of this post refers only to an unusually extended time for one ANDA applicant to obtain tentative approval for a generic version of an erectile dysfunction …

Few drugs in the history of Hatch-Waxman have as storied a history as RESTASIS (cyclosporine) Ophthalmic Emulsion, 0.05%. First, there was litigation against FDA as to the status of the drug as an “antibiotic” (see here).  Second, there’s the recent fight over whether the St. …