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  • Hatch-Waxman

    • Teeth, They Must Be Very Much Worthwhile: GAO Report on REMS Abuses Notes Lack of Agency EnforcementNovember 20th, 2019

      The Government Accountability Office released a new Report last week focusing on the oft-analyzed tactics used by some innovator or brand-name pharmaceutical manufacturers to keep generic versions of products off the market.  Like some facets of then-Commissioner Gottlieb’s Drug Competition Action Plan, the GAO Report …

    • Distorted Drug Patents: Does the U.S. Legal System Steer Researchers Away From Drugs that Take a Long Time to Develop?October 3rd, 2019

      Does the U.S. legal system steer researchers away from drugs that take a long time to develop?  That’s the question asked and answered in a new research paper authored by our friend Erika Lietzan, Associate Professor of Law at the University of Missouri School of …

    • Is California Dreamin? Reverse Payment Agreements Presumptively AnticompetitiveSeptember 18th, 2019

      Following the recent trend of state intervention where federal legislative action has failed, California passed a bill last week discouraging patent infringement settlements that delay drug competition.  Pay-for-delay settlements or “reverse-payment agreements” arise when the RLD-sponsor pays the putative generic sponsor to drop any Paragraph …

    • GDUFA II User Fees: They Saved Paradise and Put Up a Parking LotSeptember 4th, 2019

      Fall is in the air.  We know that not only beacuse the kids are off to school and the Summer heat is tailing off, but because of the uptick in questions we field on a daily basis concerning user fees under both the Prescription Drug …

    • HP&M is Pleased to Welcome Suchira Ghosh to the FirmAugust 20th, 2019

      Hyman, Phelps & McNamara P.C. (“HP&M”) is pleased to announce that Suchira Ghosh has joined the firm as Counsel.  Suchira comes to HP&M with more than 10 years of FDA and Hatch-Waxman legal experience, as well as several years of experience working as a process …

    • Dust Yourself Off and Try Again: GAO Report On ANDA Approval Shows that Multiple Review Cycles Are Still Often NecessaryAugust 9th, 2019

      Over the last few years, FDA has clearly prioritized efficient generic development (see, for example, the Drug Competition Action Plan).  While FDA hosted public meetings, published MAPP revisions, and compiled lists of off-patent/off-exclusivity drugs, Congress reauthorized the Generic Drug User Fee Act in 2017 and …

    • FDA Law Alert: Issue #2August 7th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …

    • ACI’s Paragraph IV Disputes Master SymposiumAugust 7th, 2019

      The American Conference Institute’s (“ACI’s”) popular “Paragraph IV Disputes Master Symposium” is coming up again! The conference will take place from October 3-4, 2019 at the W Chicago in City Center, Chicago, IL. ACI has put together an excellent program for conference attendees that include presentations …

    • Go for It! (Connect) Paragraph IV! FDA Revamps ANDA Paragraph IV Certifications ListJune 19th, 2019

      The Paragraph IV certification list on FDA’s website is a very useful tool for generic drug manufacturers in evaluating the potential for 180 day exclusivity for any given product. The list generally describes drug products for which one or more substantially complete ANDA containing a paragraph …

    • The BLOCKING Act: “Oh You Know, Strikes and Gutters, Ups and Downs”June 3rd, 2019

      That quote from “the Dude” from one of the final scenes of the 1998 film The Big Lebowski sums up well where things stand—or should we say “cannot stand, man”—insofar as drug pricing legislation, and, in particular, the Bringing Low-cost Options and Competition while Keeping …

    • 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 …