By Kurt R. Karst – Earlier this year we posted on two pending lawsuits brought by potential biosimilar applicants challenging the the so-called “patent dance” patent resolution provisions added to the PHS Act by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). The BPCIA …
By Kurt R. Karst – The years-long, knock-down, drag-out fight between the K-V Pharmaceutical Company (“KV”) – now known as Lumara Health Inc. – and FDA (and the Department of Health and Human Services) involving KV’s pre-term birth orphan drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, …
By Karla L. Palmer – Yesterday FDA provided drug compounders some pre-Fourth of July fireworks by issuing a slew of “policy documents” as part of the Agency’s implementation of the Compounding Quality Act (“CQA”) (Title I of the Drug Quality and Security Act (“DQSA”)), which was …
By Douglas B. Farquhar – Drug compounders who are thinking about registering with FDA to become “outsourcing facilities” – and those 40 + that already have – will be interested in the details of FDA’s recent recognition that all of the rigid requirements for “current Good …
By Kurt R. Karst – Ever since the FDC Act was amended in November 1997 by the the FDA Modernization Act (“FDAMA”) to add a new section creating a period of “pediatric exclusivity,” we’ve had more than a passing interest in the provision. In fact, it …
By Kurt R. Karst – It’s been quite a while since we last posted on the so-called “RLD (Reference Listed Drug) Theory of Liability.” It’s the theory put forward by plaintiffs’ attorneys in a lot of failure-to-warn generic drug product liability cases which posits that FDA’s …
By Kurt R. Karst – FDA’s recent posting of two Warning Letters (here and here) to companies that failed to pay Generic Drug User Fee Amendment (“GDUFA”) facility user fees for Fiscal Year 2014 (“FY14”) – for a grand total of three GDUFA Warning Letters thus …
By Kurt R. Karst – Although we’re not patent attorneys, we’re smart enough to know that the September 16, 2011 enactment of the Leahy-Smith America Invents Act (“AIA”) signaled a sea change in the patent world. Indeed, the effects of the AIA were immediately felt in …
By Kurt R. Karst – The so-called “drug lag” – i.e., the difference (or perceived difference some might say) in drug availability between the United States and other countries – was one of myriad reasons some folks back in the early 1990s thought it was necessary …
By Kurt R. Karst – After years of relative quiet, the Orange Book list of exclusivity terms has gotten quite a workout over the past year with the addition of several new terms to account for new non-patent marketing exclusivities. First there was the addition of …
By Jeffrey N. Wasserstein – As we previously noted, waiting for FDA to issue social media guidances was a little like Waiting for Godot. Well, Godot has returned and FDA finally released two long awaited draft guidances relating to social media, one relating to the presentation of …
By James E. Valentine – On June 11, 2014, a panel before the House Energy and Commerce Committee’s Subcommittee on Health hosted its second hearing on the 21st Century Cures Initiative. The Subcommittee sought input on whether current economic and regulatory incentives are sufficient to encourage …
By Kurt R. Karst – Although this blogger didn’t catch the episodes of The Six Million Dollar Man that originally aired in the mid-1970s, I did see them once they were syndicated. As I remember it, the opening theme and narration to the popular television show starring …
By Kurt R. Karst – In what might very well be the first decision in a case involving a counterclaim seeking an order to correct or delete patent information from the Orange Book (and not concerning a patent use code), last week the U.S. District Court …
By Kurt R. Karst – FDA’s Pre-Launch Activities Importation Request (“PLAIR”) program got a lot of attention last July when the Agency finally announced the issuance of a draft guidance document (Docket No. FDA-2013-D-0836) describing the program. Briefly, the PLAIR program allows, on a case-by-case basis and …
