Hyman, Phelps & McNamara's attorneys counsel and assist HPM clients in gaining government approvals for new products and in developing strategies to support successful marketing in accordance with the requirements of the law and the enforcement policies of FDA and other regulatory agencies.
By Riëtte van Laack – Legislation that would require labeling of genetically engineered or bioengineered foods (generally referred to as “GMOs”) has been proposed in various states. If enacted, these state laws may expose companies to a patchwork of different...
By James C. Shehan – The Generic Pharmaceuticals Association (“GPhA”) opened a new front in its ongoing battle to shape the approval process for biosimilars, while also calling for more cooperation between the US and the EU in their oversight of traditional generic drugs. In a joint letter to the European Commission’s Trade Commissioner and […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
By Karla L. Palmer – The Energy and Commerce Committee’s Subcommittee on Health (chaired by Representative Joe Pitts (R-PA)), has scheduled a hearing for Monday, April 7, 2014, at 3:00 p.m. in room 2123 of the Rayburn House Office Building. The hearing is titled “Improving Predictability and Transparency in DEA and FDA Regulation.” Industry and […]
By Kurt R. Karst – In a 17-count, 84-page Complaint filed earlier this week in the U.S. District Court for the District of New Jersey, Mylan Pharmaceuticals Inc. (“Mylan”) alleges that Celgene Corporation (“Celgene”) has violated federal and state antitrust...
By William T. Koustas – FDA has begun its efforts to implement the Drug Supply Chain Security Act (“DSCSA”), also known as Title II of the Drug Quality and Security Act. As we have reported in prior posts (here and here), the DSCSA requires FDA to issue a series of guidance documents and hold public […]
By Kurt R. Karst – Earlier this week, Celltrion Healthcare Co., Ltd. and Celltrion, Inc. (collectively “Celltrion”) filed a Complaint for Declaratory Judgment in the U.S. District Court for the District of Massachusetts seeking a judgment with respect to certain patents allegedly convering Janssen Biotech, Inc.’s (“Janssen’s”) biological product REMICADE. The Complaint marks the beginning […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Earlier this week we gave a “Coming Soon” announcement about a forthcoming posting of an FDA-related crossword puzzle written by Jeffrey N. Gibbs and Etan J. Yeshua as part of a celebration of Hyman, Phelps & McNamara, P.C.’s 34th anniversary earlier this month. Well, it’s here – game on folks! Below is the crossword puzzle, followed […]
By Anne K. Walsh – The Supreme Court of Arkansas recently overturned (here and here) a lower court’s $1.2 billion award to the State of Arkansas, and also reversed and remanded the decision granting over $200 million in attorney’s fees and costs to the state. Putting aside the huge dollar figures at stake for Johnson […]
By Kurt R. Karst – In a Complaint filed last Friday in the U.S. District Court for the District of Columbia, Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company (collectively “Perrigo”) (represented by Hyman, Phelps & McNamara, P.C.) allege that FDA has shirked a duty under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) by […]
By Kurt R. Karst – Since we started this blogging gig seven years ago (March 6th was our anniversary) we’ve strived to cover topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested in FDA law. Among other things, this has meant compiling […]
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
By Allyson B. Mullen – On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”). FDA, Guidance for Industry and FDA Staff, Administrative Procedures for CLIA Categorization (March 2014). The 2014 Guidance replaces the final guidance with the same name originally issued on May […]
By John A. Gilbert – The 57th session of the Commission on Narcotic Drugs (“CND”) recently convened in Vienna, Austria. A prominent issue on the first day of the general session included concern over the increased use of cannabis, especially for recreational purposes. The International Narcotics Control Board (“INCB”), which serves as the secretariat for […]
By Riëtte van Laack – Defendants Wellness Support Network, and co-owners Robert and Robyn Held, marketed two diabetes products – Diabetic Pack and Insulin Resistance – as medical foods. In 2005 and 2006, FDA issued two Warning letters to them (here and here), claiming the products were marketed as unapproved drugs. In 2007, the FTC […]
By Kurt R. Karst – It was only about a year ago when the topic du jour was generic drug labeling and whether federal law – the FDC Act and FDA’s implementing regulations – preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic drug manufacturers. In fact, we were so inundated with […]
By Allyson B. Mullen – On February 18, 2014, the FDA issued the Final Guidance “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” (the “Pre-Sub Guidance”). FDA, Guidance for Industry and FDA Staff, Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings […]