• where experts go to learn about FDA
  • Sara W. Koblitz

    • 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.  …

    • Doctoring the Law: Congress May Let FDA Regulate the Practice of MedicineDecember 22nd, 2022

      Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost.  Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) …

    • “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 …

    • Papa Can You Hear Me? Now You Can Thanks to OTC Hearing AidsAugust 18th, 2022

      After 5 long years, FDA has finally adopted the long-awaited OTC hearing aid rules.  While the Proposed Rule was a year and a half overdue, FDA impressively turned out the Final Rule about 7 months after the close of comments on the Proposed Rule, which …

    • 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 …

    • 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 …

    • Here It Goes, Here It Goes, Here It Goes Again: The Build Back Better Act (Redux)July 14th, 2022

      The Build Back Better Act—the food and drug law implications of which we discussed last year—has popped up again in Congress, and it is just as dense as ever.  With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. As we explained …

    • ‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid RulesJune 22nd, 2022

      There is a lot to unpack in the 430 pages of FDASLA, which means that some provisions are falling a little under the radar.  One of those provisions is an unusual one in which Congress directs FDA to issue final rules concerning Over-the-Counter hearing aids.  …

    • Not So Retro: FDA Says IRTNMTA Cannot Be Retroactively AppliedJune 14th, 2022

      Market exclusivities—patent or otherwise—are a critical part of the Hatch-Waxman compromise, intended to encourage continued innovation in spite of the introduction of generic competition.  Even a month of market exclusivity is financially lucrative enough to fight for, so it is no surprise that a company …

    • FDA Can’t Always Get What It Wants…So It Asks CongressJune 7th, 2022

      As the User Fee Acts move through Congress, it has been clear that FDA is using them as a vehicle to legislatively overturn some big court losses over the last few years.  As faithful readers of our blog know, FDA’s broad interpretations of its governing …

    • Prescription Drug User Fees Ex-PAND-ed to PANDAs (PANDA-monium Part II)June 2nd, 2022

      A little less than a year ago, it was PANDA-monium at FDA when the Agency created a new category of drug applications called the PANDA—or the Pre-Hatch-Waxman Abbreviated New Drug Application—which referred to abbreviated drug applications submitted and approved prior to the enactment of the …