• where experts go to learn about FDA
  • Year: 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 …

    • FDA Wants Your Input on Cybersecurity for Servicing of Medical DevicesAugust 31st, 2021

      On June 17, 2021, FDA has released a discussion paper to discuss cybersecurity issues related to the servicing of medical devices. We have previously posted blogs about FDA’s increasing interest on cybersecurity both in the premarket (see our past blog posts here, here, and here) and the postmarket …

    • DOJ Re-Brands Guidance DocumentsAugust 30th, 2021

      Companies often use rebranding to reposition and refocus their business.  Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally.  The federal government does its own version of rebranding with each change in administration.  Just before the July 4 holiday weekend, …

    • FIFA Cases Hold Lessons for FDA-Regulated Companies – Organizations can be Victims of Their Own Employees’ Criminal ConductAugust 26th, 2021

      It is a well-accepted fact that even well run ethical and compliant organizations can have serious problems.  The Sentencing Guidelines, the DOJ Manual, and the HHHS OIG–among others–all recognize that reality.  In its Compliance Guidance for Pharmaceutical Manufacturers, the HHS OIG notes: The OIG recognizes that …

    • PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker ProgramsAugust 24th, 2021

      On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals, which takes effect on January 1, 2022.  The PhRMA Code is a voluntary code of conduct focusing on the …

    • It’s Groundhog Day for Food Labeling, Again: The Food Labeling Modernization Act is BackAugust 20th, 2021

      In a repeat of 2013, 2015 and 2018, Rep. Frank Pallone (D-N.J.) has yet again introduced the Food Labeling Modernization Act (FLMA).  As in the past, there are a few new things of note, and a few other things have been removed (e.g., requirements for …

    • It’s PANDA-monium at FDAAugust 17th, 2021

      Meet the newest category of drug applications: the PANDA.  A PANDA, or the Pre-Hatch-Waxman Abbreviated New Drug Application, refers to abbreviated drug applications submitted and approved under sections 505(b) and 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) prior to the enactment of …

    • The 6-Year Saga Finally Ends: FDA Issues Final Rule Modifying The Intended Use RegulationAugust 16th, 2021

      A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices.  It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply.  It is embodied in parallel drug and …

    • The Code is Cracked: Interchangeable Biologics are HereAugust 13th, 2021

      About two weeks ago, FDA made an exciting announcement (and it remains exciting even if we’re late posting about it): FDA approved the first interchangeable biosimilar.  On July 30, 2021, FDA approved Semglee (insulin glargine-yfgn), an insulin product that relies on Lantus (insulin glargine) as …