• where experts go to learn about FDA
  • Month: August 2022

    • 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 …

    • Proposed Rule for Organic Livestock and Poultry Production; Outdoor Access Requires More than a Screened PorchAugust 17th, 2022

      On August 5, the United States Department of Agriculture’s Agricultural Marketing Service (AMS) announced a proposal to amend the organic livestock and poultry production requirements by adding new provisions for livestock handling, transport for slaughter, and avian growing/living conditions, as well as provisions to clarify …

    • FDA Inspections Back Up To Speed (Except Those Now Deemed Unnecessary)August 16th, 2022

      Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID.  That impression was corroborated this week at the GMP by the …

    • Landmark Drug Pricing Bill Set to Become Law; HP&M Releases Summary Slide DeckAugust 15th, 2022

      The Inflation Reduction Act of 2022 (“IRA”) has now passed both the Senate (on August 7) and the House (on August 12), and is headed to President Biden for signature.  We have prepared a slide deck that summarizes Subtitle B of the IRA, entitled “Prescription Drug …

    • 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 …

    • Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback StatuteAugust 5th, 2022

      In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS).  Pfizer, Inc. v. U.S. Department of Health and Human Services …

    • 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 …

    • ACI’s FDA Boot Camp – September 14-15, 2022 (Virtual)August 5th, 2022

      The American Conference Institute is hosting their 39th FDA Boot Camp from September 14-15, 2022.  The conference will be held virtually. Gain insight and training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts. The approval process, pre-approval concerns, product labeling, clinical trials, …

    • 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 …

    • It’s My Party and I’ll Cry if I Want to: A Bittersweet Happy 30th Birthday to LDTsAugust 3rd, 2022

      Happy Birthday Laboratory Developed Tests (LDTs). Thirty years ago today, FDA announced that it had the authority to regulate you.  Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products.  …

    • Biden Administration Facing Renewed Pressure to Legalize CannabisAugust 2nd, 2022

      At least one public interest group and several members of Congress remain frustrated with the Biden Administration’s failure to take action to legalize cannabis.  Within the last month, the Cannabis Regulators of Color Coalition (“CRCC”) and handful of Democratic Senators have separately reached out to …