As we previously noted, the intersection of exclusivity and off-label promotion issues is not common, but quite an interesting issue nevertheless. The intersection of these issues was raised earlier this year when Egalet Corporation (“Egalet”) issued a press release saying that the company had received …
The Orange Book has undergone – and continues to undergo – a lot of change as a result of FDA’s October 2016 promulgation of final regulations (effective as of December 5, 2016) to implement parts of the December 8, 2003 Medicare Modernization Act (“MMA”). We …
Amgen Inc.’s (“Amgen”) nearly two-week-old lawsuit filed against FDA in the U.S. District Court for the District of Columbia challenging the Agency’s denial of a period of 6-month pediatric exclusivity under the Best Pharmaceuticals for Children Act (“BPCA”) (FDC Act § 505A) applicable to SENSIPAR …
The drought is over! It’s been several months since we’ve seen a new dispute over non-patent exclusivity filed against FDA in a court. But with a May 25, 2017 Complaint and a Motion for Temporary Restraining Order and/or Preliminary Injunction filed in the U.S. District …
Earlier this week, the Subcommittee on Health of the House Energy and Commerce Committee held a mark-up session of several bills, including H.R. 2430, the FDA Reauthorization Act of 2017 (“FDARA”). (The Senate version of FDARA, S. 934, passed out of committee earlier this month.) …
Since it was first published in 1980, the Orange Book has undergone a lot of change. Over the decades we’ve seen the publication transform and evolve from a paper edition to an electronic database, and now to an app (see our previous post here). Although …
The American Conference Institute’s (“ACI’s”) “FDA Boot Camp: Drugs & Biologics Edition” – now in its 30th iteration – is scheduled to take place from September 13-15, 2017, at the Omni Parker House, in Boston, Massachusetts. The conference is billed as the premier event to …
In a new paper, titled “The Drug Innovation Paradox,” Professor Erika Lietzan of the University of Missouri School of Law (and a friend and fellow Hatch-Waxman addict) examines the relationship between the incentives offered under the law to develop drug products and the research and …
Every once in a while we come across an instance in which FDA’s Paragraph IV Patent Certifications List does not comport with our own 180-Day Exclusivity Tracker. Either the date on FDA’s list is different from the date we have (perhaps because of a change …
As simple as it may seem, counting can be a difficult human endeavor! You need only recall Monty Python’s Holy Hand Grenade of Antioch skit to cement that fact! Over the years we’ve commented (e.g., here) on the difficulty with counting to 60. That’s the magic …
In the rhythm of life, timing is everything! It was just last week when we posted on an interesting issue arising as a result of the intersection of exclusivity and off-label promotion. We suggested that some controversy might arise as a result of some decisions …
The intersection of exclusivity and off-label promotion issues is not common, but quite an interesting issue nevertheless. A recent press release from Egalet Corporation (“Egalet”) raises the possibility that FDA may be challenged – perhaps in court – as a result of the Agency’s decision …
On March 29, 2017, Senator Al Franken (D-MN) and several other Senate Democrats introduced S. 771, the “Improving Access to Affordable Prescription Drugs Act.” A companion bill, H.R. 1776, was introduced in the House on the same day by Representatives Jan Schakowsky (D-IL), Elijah Cummings …
The American Conference Institute’s (“ACI’s”) 11th annual “Paragraph IV Disputes” conference is right around the corner! The conference will take place from April 24-26, 2017 at the Conrad New York in New York, NY. ACI has put together an excellent program for conference attendees that includes presentations from esteemed …
Cue up Neil Sedaka’s 1962 hit “Breaking Up Is Hard to Do,” or, for some of us younger-minded folk, take your pick from one of many Taylor Swift songs (“We Are Never Ever Getting Back Together,” “I Knew You Were Trouble,” and so many more). What …
