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    • B-B-B-B-Bad to the Bone? The Brought Back BLOCKING Act: Better, But Still Bad for Business and BuyersMay 2nd, 2023

      On the day I was born The nurses all gathered ‘round And they gazed in wide wonder At the joy they had found The head nurse spoke up Said, “Leave this one alone” She could tell right away That I was bad to the bone   As we noted in our post yesterday, on …

    • New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial ReviewMay 1st, 2023

      On May 2nd, the U.S. Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review.  That bill is S. 1067, the “Ensuring …

    • A PSA on PSGs: PSG Meetings Are Now AvailableMarch 6th, 2023

      FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug.  As the Office of Generic Drugs (“OGD”)  has stated, “[t]he clarity and transparency provided by PSGs help streamline generic drug product development, …

    • Eleventh Circuit’s Decision is Not a Catalyst For ChangeFebruary 1st, 2023

      FDA has not been shy about its distaste for the Catalyst decision; the Agency has published on its website the litany of problems that arise from it and has sent emails and letters to stakeholders essentially urging them to contact Congress to address the decision.  …

    • FDORA Enacted; HP&M Issues Detailed Summary and AnalysisJanuary 23rd, 2023

      On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (2022).  FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public …

    • ACI’s 40th FDA Boot Camp – March 22-23, 2023 (Virtual)January 3rd, 2023

      Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. This year’s conference co-chairs include …

    • “I’m Listening,” Says the PTODecember 15th, 2022

      In the wake of President Biden’s July 2021 Executive Order—Promoting Competition in the American Economy—and the exchange of letters between the Patent and Trademark Office (USPTO) and FDA, the USPTO announced recently a “public listening session” in collaboration with FDA to seek comments on how …

    • Is the Listing of REMS Patents in the Orange Book Patently Anticompetitive?November 18th, 2022

      FTC sure thinks so.  And the FTC said as much in a recent Amicus Brief (“Brief”) in paragraph IV litigation between Avadel CNS Pharmaceuticals (“Avadel”) and Jazz Pharmaceuticals Inc. (“Jazz”).  This type of statement from the FTC is unprecedented; not only is the FTC Brief …

    • FUFRA Enacted; HP&M Issues Detailed Summary and AnalysisNovember 9th, 2022

      On September 30, 2022, President Biden signed into law the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, Division F of which is titled the “FDA User Fee Reauthorization Act of 2022” (“FUFRA”).   In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several …

    • New Lawsuit Challenges FDA’s Authority to Compel Patent CertificationsAugust 11th, 2022

      For years, FDA has been wrestling with questions about what patents should be listed in the Orange Book, but, as we have reported, FDA has made little to no progress on addressing those questions.  One of those pressing questions that remains unanswered involves the listing …

    • ACI’s Paragraph IV Disputes Master Symposium – September 21-22, 2022 (Chicago)August 5th, 2022

      Join members of the Judiciary and leading pharmaceutical patent litigators from brand name and generic drug companies at the American Conference Institute’s 8th Annual Paragraph IV Disputes Master Symposium taking place September 21-22, 2022, in Chicago! As the industry prepares to address the fallout of global …

    • Teva Gets Knocked Down, But It Gets Up Again—and Petitions SCOTUSAugust 4th, 2022

      Teva may be down, but it’s not out yet.  By now, the ongoing Teva v. GSK litigation— concerning induced infringement of patents covering the use of carvedilol in decreasing mortality caused by congestive heart failure in a patient—is well-worn territory (see our multiple posts on …

    • Everything You Wanted to Know About the Orange Book But Were Too Afraid To AskJuly 26th, 2022

      In its second Orange Book Guidance in as many days, FDA is addressing all of your burning questions about the Orange Book—and boy are we excited at the Agency’s efforts to make the Orange Book accessible for everyone!  The Guidance is a Frequently Asked Questions …

    • TE Codes 101: FDA Guidance Teaches Basics of Therapeutic Equivalence CodesJuly 24th, 2022

      The Orange Book’s Therapeutic Equivalence Codes (TE Codes) play a critical role in our drug distribution and payment system.  All states have “automatic substitution” laws that require prescriptions to be filled using a generic where available (unless otherwise ordered by the physician), and those substitutions …

    • Is FDA Going to Get A Little Help From Its Friends at the PTO?July 21st, 2022

      Drug pricing has been a hot button issue in the U.S. for decades, and patent protections have been cited as a source of “gamesmanship” allowing brand companies to keep drug prices high.  Yet, as long as FDA and FTC have been trying to address anticompetitive …