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  • Hatch-Waxman

    • You Don’t Change Horses in Mid-Stream: Product-Specific GuidancesMay 7th, 2019

      As you may have noticed, FDA recently unveiled a new website.  As part of this redesign, FDA “enhanced” the Product-Specific Guidances (“PSG”) for Generic Drug Development web page.  The “enhanced” version of the website includes new database and search function features, export features, and paginated …

    • When is a Period Not a Period? The Curious Case of Ivabradine and Pediatric ExclusivityApril 30th, 2019

      FDA’s interpretation and application of the Best Pharmaceuticals for Children Act (“BPCA”), which provides for a 6-month add-on period of pediatric exclusivity has piqued our interest more than once over the years, leading to several posts (see, e.g., here, here, and here).  We now have …

    • In a Parallel Universe: FDA Authorizes First REMS “Parallel System”April 3rd, 2019

      As we discussed last summer, FDA has recognized that negotiations surrounding the development of a Single, Shared System REMS may fail, and, to that end, issued a guidance detailing the Agency’s waivers process.  Now, the market has borne the fruits of that labor in the …

    • Don’t Test Me! FDA Applies “Deemed Triggered” Regulation to 180-Day Generic Drug ExclusivityApril 2nd, 2019

      “Don’t test me!”— that’s a warning that I, along with my younger brother, Erik, heard more than once from our parents while growing up.  The warning would come up from time to time—but particularly during our teenage years—when teenagers do what they sometimes do: challenge …

    • ANDA Suitability Petitions: The Way Back to Normalcy (and Some Sanity)March 26th, 2019

      The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments.  For several years after the enactment of Hatch-Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.  And although …

    • ACI’s 13th Annual Paragraph IV Disputes ConferenceMarch 26th, 2019

      Spring is here!  How do we know?  Is it the cherry blossoms starting to bloom in Washington, DC?  Is it the daffodils emerging from hibernation?  No – we know it’s Spring because the annual American Conference Institute (“ACI”) “Paragraph IV Disputes” conference is right around …

    • FDA: Recent Media Reports Calling Into Question the Quality of the Nation’s Generic Drug Supply Are Seriously FlawedFebruary 28th, 2019

      After months of ever expanding drug recalls, and multiple investigative reports by different media outlets calling into question the safety of the U.S. generic drug supply (see, for example, “America’s Love Affair with Cheap Drugs has a Hidden Cost,” “How a Tainted Heart Drug Made …

    • You Down With CGT?February 18th, 2019

      Yeah, you know me. Given Commissioner Gottlieb’s clear proclivity for blog posts with song titles rather than Orange Book puns, we’ll stick with those for a while. We just hope the Commissioner likes early 1990s rap as much as he likes rock from the 1970s …

    • FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same MessageFebruary 12th, 2019

      FDA released its annual Report to Congress on 505(q) Citizen Petitions last week – the Tenth Annual Report to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017.  The Report, which is …

    • HP&M’s Hatch-Waxman Practice Grows With the Addition of Michael ShumskyFebruary 8th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Michael Shumsky has become its newest Director.  Mike joined HP&M in February 2019 after nearly 15 years at Kirkland & Ellis LLP, where he played a key role in developing that firm’s FDA and …

    • Orange You Glad We Didn’t Make an Orange Book Pun?February 4th, 2019

      In yet another step to address drug pricing, Commissioner Gottlieb announced last week several new initiatives, including an update to the revered Orange Book.  Cue the crazy Muppet arms!  Proclaiming the Orange Book update a “transparency initiative,” FDA expects that this undertaking will “provide greater …

    • This Cannot Stand, Man! The BLOCKING Act of 2019 Would Unnecessarily Reform 180-Day Generic Drug ExclusivityFebruary 1st, 2019

      Over the 12 years that we’ve been doing this blogging gig, we’ve never before drawn inspiration for a post from Lebowski Pony – a.k.a. “the Dude” – that iconic character from the 1998 film The Big Lebowski, written and directed by Joel and Ethan Coen. …

    • M.C. Escher By Way of Generic Drug PricingJanuary 18th, 2019

      Though FDA does not have the legal authority to control or even directly address drug prices, Commissioner Gottlieb has certainly not shied away from the issue.  In fact, drug (and biologic) competition and accessibility is one of Dr. Gottlieb’s main efforts at the Agency (see …

    • The FTC and FDA May Face New Hurdles in Injunction ActionsDecember 13th, 2018

      On December 11, 2018, the authors of this blog post attended the oral argument in Federal Trade Commission v. Shire ViroPharma, Inc., No. 18-1807 (3d Cir. filed Apr. 12, 2018).  We have previously blogged about the case here, here, and here. In a nutshell, Shire …

    • International Plan of Mystery: ICH Guidelines for Generic DrugsNovember 28th, 2018

      Back in October, FDA announced that it submitted a proposal to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the development of common global standards for generic drugs. This proposal is yet another strategy in Commissioner Gottlieb’s Drug …