By William T. Koustas – FDA has issued a new draft guidance titled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (Draft Guidance). This Draft Guidance is the first of many to come in FDA’s implementation of the Drug Supply Chain Security …
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 Riëtte van Laack – In Quesada v. Herb Thyme Farms, Inc., Plaintiff Quesada alleged that Herb Thyme Farms, Inc. (Herb Thyme) lied about the nature of its “Fresh Organic” line of herbs. According to Plaintiff, Herb Thyme misrepresented its “Fresh Organic” products as 100% percent …
By Anne K. Walsh – Late last Friday afternoon, FDA issued a new guidance document describing FDA’s recommended practices for distributing reprints that convey new risk information for approved drug and biologic products. The guidance defines “new risk information” as information that becomes available after a …
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Request (“PLAIR”) program got a lot of attention last July when the Agency finally announced the issuance of a draft guidance document (Docket No. FDA-2013-D-0836) describing the program.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 …
By Alexander J. Varond – On May 29, FDA issued its final guidance on “Expedited Programs for Serious Conditions – Drugs and Biologics.” We blogged previously on the draft guidance and each of FDA’s four expedited programs (fast track designation, accelerated approval, priority review, and breakthrough …
By Kurt R. Karst – FDA’s recent announcement that the Agency seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories (“Ascend”) is the latest, and most clear example yet of FDA taking action pursuant to the Agency’s September 19, 2011 Marketed Unapproved Drugs …
By James C. Shehan & David B. Clissold – Good brand names have been important to drug marketers as far back as Biblical times – the Book of Ecclesiastes tells us that “a good name is better than precious ointment.” In a new draft guidance applicable …
By JP Ellison & Anne K. Walsh – On May 22, 2014, the Justice Department announced that it had made a significant policy change regarding its policy concerning whether to electronically record statements made by individuals. A copy of the relevant DOJ memo is available here. Beginning …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Jay W. Cormier & Alan M. Kirschenbaum – Last summer, the Health Resources and Services Administration (“HRSA”) promulgated a final regulation to implement a statutory provision, added by the Affordable Care Act, that excludes orphan drugs from the ceiling price limitations of the 340B Program …
By Ricardo Carvajal – FDA filed a motion to dismiss the lawsuit brought by the Center for Food Safety challenging the legality of FDA’s GRAS notification program (for background information on the lawsuit, see our prior posting here). In its supporting memorandum, FDA argues that plaintiff …
By Kurt R. Karst – We’re not sure if it was merely the passage of time or something else that relieved the constipation, but FDA has finally acted on an October 24, 2008 Notice for an Opportunity for Hearing (Docket No. FDA-2008-N-0549) proposing to withdraw approval …
The American Conference Institute (“ACI”) will hold its 5th annual Summit on Biosimilars from June 5-6, 2014 at the InterContinental New York Barclay, New York, New York, and a pre-conference primer on June 4th with sessions titled “Biosimilars 101: Comprehensive Deep Dive Into the Relevant …
By Alan M. Kirschenbaum – CMS has posted relevant dates, instructions and other information regarding “Phase 2” of the 2014 reporting process under the Physician Payment Sunshine Act. (Background on this law and the 2014 reporting process can be found here.) CMS announced that Phase 2 of …
