By James C. Shehan – Aficionados of pro wrestling can regale you with the exploits of tag teams like The Bruiser and the Crusher, The Wild Samoans and The Fabulous Freebirds. The moniker FDA-IRS-FTC is far less colorful and mellifluous than those of WWE stars, but …
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 Karla L. Palmer – Last week, several congressional representatives announced the introduction of H.R. 3537, the “Synthetic Drug Control Act of 2015.” If enacted, the Synthetic Drug Control Act would strengthen existing federal law (specifically, the Controlled Substances Analogue Enforcement Act) (“Analogue Act”), which provides that …
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 Riëtte van Laack & Etan J. Yeshua – As we previously reported, when FDA announced a new compliance date for the menu labeling rule, it also announced that it would issue guidance. On Friday, September 11, FDA issued the promised draft guidance. The draft guidance is …
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 Ricardo Carvajal & Riëtte van Laack – FDA released pre-publication versions of the two final rules on current good manufacturing practice and preventive controls requirements – one governing human food (here), and the other animal food (here). The pre-publication versions total over 1,500 pages, so will …
The Expert Institute recently informed us that the organization is holding a “Best Legal Blog Competition” and that the FDA Law Blog has been selected to participate in the competition. From a field of more than 2,000 potential nominees, FDA Law Blog has received enough …
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 …
By Kurt R. Karst – The Order handed down last week by the U.S. Court of Appeals for the Federal Circuit denying Amgen Inc.’s (“Amgen’s”) Emergency Motion For An Injunction Pending En Banc Consideration and Review and Sandoz Inc.’s (“Sandoz’s”) September 3, 2015 launch of the …
By Kurt R. Karst – Finger through the “Discontinued Drug Product List” section of the Orange Book and youl’ll quickly realize that there are a lot of drug products no longer marketed. The “Discontinued Drug Product List” spans 337 pages in the current annual edition of …
By Alan M. Kirschenbaum, Michelle L. Butler & David C. Gibbons – On August 28, 2015, the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services published an omnibus guidance document to implement the 340B Drug Discount Program (the Proposed Guidance). Since …
