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  • Month: September 2021

    • Drug Pricing Reform Gathers Steam (Part 2)September 15th, 2021

      Drug pricing and payment reform is a three-legged stool drawing support from the Administration, the House, and the Senate.  Yesterday our post focused on the Administration’s priorities and initiatives, as described in HHS’s recent Comprehensive Plan for Addressing High Drug Prices.  Today we focus on …

    • Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat PrioritiesSeptember 14th, 2021

      Despite vigorous criticism of high drug prices from the public and politicians in both parties, drug companies have largely dodged bullets on drug pricing and payment reform.  In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and …

    • First North Dakota Quarterly Drug Price Transparency Reports Due in OctoberSeptember 13th, 2021

      Earlier this year, North Dakota enacted a prescription drug price transparency reporting law, HB 1032, that became effective on August 1, 2021. (See our summary here.) This new law requires prescription drug manufacturers to report the current wholesale acquisition cost (WAC) information for drugs sold …

    • FSIS Begins the Process of Rule Making for Labeling of Cultured or Cell-Based Meat and PoultrySeptember 9th, 2021

      As readers of our blog know, FDA and the Food Safety Inspection Service of the USDA (FSIS) agreed to jointly oversee the production of human food products using animal cell culture technology.  Under the Memorandum of Understanding signed in March 2019, FDA will oversee cell …

    • Ding Dong is the Skinny Label (Effectively) Dead?September 7th, 2021

      Innovators rejoice while generic sponsors mourn: In the wake of the latest in GSK v. Teva decision, the skinny label may be dead. The “skinny label,” also known as a “carve-out” or a “section viii statement,” is a widely-used statutory provision adopted in the Hatch Waxman …

    • Giving Regulatory Due Diligence Its DueSeptember 2nd, 2021

      The adage that “no one is perfect” applies as equally to companies as it does to people.  Before committing to a merger or acquisition with another company, a potential Buyer must conduct due diligence to identify the imperfections of a target company so the Buyer …

    • Is Facebook Ghosting Pharma?September 1st, 2021

      In what appears to be an “about face” in terms of Facebook’s historical wooing of big pharma (are we the only ones that immediately thought, “More Cowbell” when seeing that headline?  You can thank us for that 5 minute rabbit hole later), the social media …