By Kurt R. Karst – Predicting the future is a tricky business. Predictions don’t often pan out, even when most or all of the indicators prognosticators use say something will (or will not) happen. We have a pretty decent track record of guessing how a case …
By Jeffrey K. Shapiro – A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. The intended use of …
By James E. Valentine* – In recent years there has been an increasing focus on patient engagement, centering on new opportunities for FDA to incorporate the patient perspective into its regulatory decision making. These discussions have resulted in Congress and FDA establishing new policies and programs …
By Kurt R. Karst – Hatch-Waxman controversies are often like trains barreling down railroad tracks. They first appear in the distance as small objects, seemingly moving at a slow velocity. But with each passing moment, the object grows larger and more distinct, and appears to pick …
By James E. Valentine* & David C. Clissold – On September 8, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies announced a Notice of Proposed Rulemaking (NPRM) to revise the Federal Policy for the Protection of Human Subjects, …
By Kurt R. Karst – On September 30, 2015, Judge Randolph D. Moss of the U.S. District Court for the District of Columbia issued his highly-anticipated decision in a lawsuit lodged by Eisai Inc. (“Eisai”) last August challenging FDA's April 2014 denial of a Citizen Petition (Docket No. FDA-2013-P-0884) requesting that the Agency conclude that the …
By Kurt R. Karst – FDA recently released the Agency’s Seventh Annual Report to Congress, required by FDC Act § 505(q)(3), on FDA’s experience during Fiscal Year 2014 (“FY 2014”) with citizen petitions subject to FDC Act § 505(q). Other than some updated numbers fo FY …
By Kurt R. Karst – The legal world is chock-full of tests, doctrines, and processes named after a particular case or court decision. It’s kind of a legal short-hand; a lexicon of legal eponyms. There’s the “Winter Standard” for preliminary injunctions in federal courts; the “Lemon …
By Kurt R. Karst – One day in the future, reporting on biosimilar patent dance challenges lodged pursuant to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) will be considered passé. Such challenges will be as commonplace as Hatch-Waxman Paragraph IV challenges. Indeed, earlier …
By Kurt R. Karst – Finding new ways to incentivize and reward drug development for particular therapeutic needs is all the rage these days. Over the past few years we’ve seen several new incentives incorporated (and proposed for incorporation) into the FDC Act. These new incentives …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features an analysis of the recent case of Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. May 7, 2015), written by Hyman, Phelps & McNamara, P.C. attorneys David C. Gibbons and Jeffrey N. …
By David C. Gibbons & Anne K. Walsh – In the wake of what industry is touting as Amarin’s First Amendment victory (read our Amarin posts here and here), Pacira Pharmaceuticals, Inc. (“Pacira” or the “Company”) filed a suit raising similar claims in the same district …
By Kurt R. Karst – In a September 10, 2015 Response to a September 2, 2011 Citizen Petition (Docket No. FDA-2011-P-0657) submitted by the National Organization for Rare Disorders (“NORD”), FDA refuses to add a statement to guidance documents concerning orphan drugs that the Agency’s official …
By Kurt R. Karst – Last week, Senators Amy Klobuchar (D-MN) and Charles Grassley (R-IA) announced the introduction of S. 2019, the Preserve Access to Affordable Generics Act. The bill is the latest attempt to pass legislation to address pharmaceutical patent settlement agreements (aka “reverse payment …
By Kurt R. Karst – It’s been a while since we peeked in on the appeals Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”) filed with the U.S. Court of Appeals for the District of Columbia …
