By Ricardo Carvajal – A California district court granted Defendants’ motion to dismiss in a putative class action brought by Plaintiffs who alleged that certain plant-based beverages, including soymilk, almond milk, and coconut milk, were misbranded because FDA defines “milk” as being derived from lactating cows. …
By Kurt R. Karst – There’s a hot debate brewing over whether or not a biosimilar biological product licensed under Section 351(k) of the Public Health Service Act (“PHS Act”), as added by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), should share the …
By Anne K. Walsh – With no fanfare, the U.S. Supreme Court on Monday denied a writ of certiorari in a case watched closely by the drug and device industry. As reported earlier, the former CEO of InterMune Inc., Scott Harkonen, had filed a petition asking the …
By Riëtte van Laack & Wes Siegner – Hyman, Phelps & McNamara, P.C. has filed comments to FDA’s Draft Guidance on Frequently Asked Questions about Medical Foods – Second Edition. As discussed in a prior post, FDA’s Draft Guidance seeks to establish a policy with respect …
By Kurt R. Karst – In a recent Complaint filed in the U.S. District Court for the Western District of Washington (at Seattle), several trade groups – the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Generic Pharmaceutical Association (“GPhA”), the Biotechnology Industry Organization (“BIO”), and …
By Jennifer D. Newberger – As part of the Medical Device User Fee Act of 2012 (MDUFA III) Commitment Letter, FDA and the medical device industry agreed to participate in a comprehensive assessment of the medical device review process. MDUFA III Commitment Letter (April 18, 2012), …
By Kurt R. Karst – Last week, FDA announced the issuance of a long-anticipated draft guidance document, titled “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules,” providing details on acceptable physical attribute differences between generic drugs and their NDA Reference Listed Drug (“RLD) …
By Kurt R. Karst – On December 12th, a group of bipartisan lawmakers led by Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) introduced H.R. 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013 (“ADAPT Act”). If enacted, the ADAPT Act would, among other …
By Kurt R. Karst – Congress has been silent on new legislation addressing drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”) since the U.S. Supreme Court issued its June 2013 opinion in Federal Trade Commission v. Actavis, Inc., 570 U.S. ___ (2013). As …
It’s been quite a month for Hyman, Phelps & McNamara, P.C. (“HP&M”)! First, the American Bar Association named the FDA Law Blog to the 2013 ABA Journal Blawg 100 (see here). Now there are three more honors to report! Earlier this week at the Food and …
By Riëtte van Laack – In addition to the many (more than 20,000) comments to FDA on the draft rules regarding Produce and Preventive Controls implementing the Food Safety Modernization Act (“FSMA”) (Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921), FDA has received a flurry of letters from Congress …
By Jennifer M. Thomas – To the extent that Plaintiffs, or interested observers, hoped the District Court for the District of Columbia would seize an opportunity to take FDA to task for failing to prevent or stop drug shortages, they were disappointed by Judge Howell’s Thanksgiving …
By Kurt R. Karst – Our hopes that FDA might publish a proposed rule to implement at least some of the changes made to the Hatch-Waxman Amendments to the FDC Act by the Medicare Modernization Act (“MMA”), enacted on December 8, 2003, before the 10-year anniversary …
By Kurt R. Karst – A Complaint recently filed in the U.S. District Court for the District of Delaware by Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) against Par Pharmaceutical, Inc. (“Par”) concerning notice of a Paragraph IV certification contained in an ANDA Par submitted to FDA for …
The Food and Drug Law Institute (“FDLI”) will hold is annual – and quite popular – Enforcement, Litigation and Compliance Conference from December 10-11, 2013 at The Westin Georgetown in Washington, DC. You can register for the conference here. A copy of the conference agenda …
