• where experts go to learn about FDA
  • Month: July 2018

    • FDA’s Product Jurisdiction Proposal: More Changes are NeededJuly 19th, 2018

      Following our blog post on the topic, in which we urged others to comment in response to FDA’s Proposed Product Jurisdiction rule changes, we decided to take our own advice. On July 15, 2018, Hyman, Phelps & McNamara, P.C. filed comments to Docket No. FDA-2004-N-0191. Our …

    • Maine Law Aims to Increase Generic Drug Developers’ Access to Reference SamplesJuly 17th, 2018

      By Michelle L. Butler & Eliot Markman* – On July 4, 2018, 2017 ME S 432, titled “An Act To Require Drug Manufacturers To Comply with Federal Law” (the “Act”), became law without Maine Governor Paul LePage’s signature.  The Act amends 32 M.R.S.A. § 13702-A and …

    • FDA Proposes Amendment to Vending Labeling Rule Requirement for Font SizeJuly 16th, 2018

      In 2010, the Federal Food, Drug, and Cosmetic Act (FDC Act) was amended to include a requirement that certain vending machine operators engaged in operating and owning 20 or more vending machines provide calorie declarations for certain articles of food sold from vending machines. FDA …

    • PCAST Recommendation in Action: “Wildcard Exclusivity” Proposed for “Priority Antimicrobial Products”July 13th, 2018

      Way back in September 2014, the President’s Council of Advisors on Science and Technology (“PCAST”) released a report to the President, titled “Combating Antibiotic Resistant Bacteria.”  The report was part of a broader initiative announced by the Obama Administration to address the growing challenges posed …

    • Following Regulation, PhRMA and BIO Drop Challenge to State Drug Pricing LawJuly 11th, 2018

      By Alan M. Kirschenbaum & Eliot Markman* – On Thursday, June 28, 2018, two industry trade associations, Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Innovation Organization (“BIO”), agreed to drop a lawsuit against Nevada related to S.B. 539, a 2017 diabetes drug price increase …

    • Whither Regulation of Animal Cell-Cultured Foods?July 10th, 2018

      To anyone with an interest in that question, FDA’s public meeting later this week is a can’t miss event.  Perhaps the most critical issue facing this nascent industry is the need for clarity on which federal agency – FDA or USDA – will exercise jurisdiction …

    • New DOJ Policy Purports to Prevent Piling-On of PenaltiesJuly 9th, 2018

      Rather than rolling out the red carpet, DOJ has been highlighting with little fanfare a policy that could prove to be a powerful negotiating tool for companies in the government’s crosshairs. First announced by Deputy Attorney General Rod Rosenstein here, and later reinforced by Acting …

    • California to Pharmacies: Start Balancing your Opioid CheckbookJuly 6th, 2018

      The Drug Enforcement Administration (“DEA”) and the states are struggling with how to confront the challenges posed by the opioid abuse crisis. One aspect of this problem relates to employee theft, particularly at the pharmacy level. The California Board of Pharmacy (“BOP”), as well as …

    • FSIS Invites Comments on Petition Regarding Product of USA Labeling for Meat and Meat ProductsJuly 3rd, 2018

      On June 22, the Food Safety and Inspection Service (FSIS) announced the receipt of a Petition by the Organization for Competitive Markets and the American Grassfed Association to revise FSIS’s policy on “Product of USA” claims so that only U.S. domestic meat and meat products …

    • Blind Voting and PMA Advisory Panels: “Do Great Minds Think Alike?”July 2nd, 2018

      By Jeffrey N. Gibbs and David A. Gibbs* – FDA’s premarket approval (PMA) advisory panels are high visibility events. Both FDA and companies invest heavily in preparing for these meetings. Thus, when the rules governing PMA panel meetings change, it should be big news. Yet, when FDA …