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    • Trump Administration Takes a Turn at Medicare Part B Payment ReformNovember 7th, 2018

      On October 30, 2018, the Centers for Medicare and Medicaid Services (CMS) issued an Advanced Notice of Proposed Rulemaking (ANPRM) soliciting public feedback on a potential International Pricing Index (IPI) Model for payment of certain drugs covered under Medicare Part B. 83 Fed. Reg. 54546 …

    • Dead Men Tell No Tales . . . and They Don’t Violate the FTC Act, EitherOctober 17th, 2018

      Earlier this year, we blogged on an interesting case out of the District of Delaware, FTC v. Shire ViroPharma, No. 17-cv-00131 (D. Del. Feb. 7, 2017), which called into question the FTC’s authority to litigate pursuant to section 13(b) of the FTC Act (15 U.S.C. …

    • FDA’s Insanitary Conditions Revised Draft Guidance: Required Reading for Compounding FacilitiesOctober 11th, 2018

      Late last month, FDA published revised draft guidance, titled “Insanitary Conditions at Compounding Facilities: Guidance for Industry.”  The revised guidance comes two years after FDA released its August 2016 draft guidance addressing what it considers “insanitary conditions” during inspections of both Section 503A pharmacies and Section …

    • Following Regulation, PhRMA and BIO Drop Challenge to State Drug Pricing LawJuly 11th, 2018

      By Alan M. Kirschenbaum & Eliot Markman* – On Thursday, June 28, 2018, two industry trade associations, Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Innovation Organization (“BIO”), agreed to drop a lawsuit against Nevada related to S.B. 539, a 2017 diabetes drug price increase …

    • FDA Plays Hardball With Two Stem Cell ClinicsMay 15th, 2018

      The U.S. Food and Drug Administration, in two complaints (here and here) filed last week in federal court, is seeking permanent injunctions to prevent two stem cell clinics from marketing stem cell products without FDA approval. Specifically, a permanent injunction is being sought against US Stem …

    • How Safe is the Safe Harbor?April 18th, 2018

      As the breadth of the “patent safe harbor” continues to expand under the Federal Circuit’s growing body of relevant case law, some patent holders are looking to the Supreme Court to push back. In a Petition for Certiorari filed last week in Classen Immunotherapies v. Elan …

    • Fourth Circuit Finds Maryland Price Gouging Law UnconstitutionalApril 16th, 2018

      On Friday, April 13, 2018, the U.S. Court of Appeals for the Fourth Circuit ruled that Maryland’s law prohibiting “price gouging” by generic pharmaceutical manufacturers (HB 631) is unconstitutional because it violates the dormant commerce clause by directly regulating transactions that occur outside of Maryland. …

    • “Sham” Citizen Petition Case Opinion Calls FTC’s Litigation Authority Into QuestionMarch 26th, 2018

      Last February we reported on FTC v. Shire ViroPharma, in which the Federal Trade Commission (FTC) took the relatively unusual (although not unprecedented) step of suing a brand drug company for anti-competitive use of the Food and Drug Administration’s (FDA’s) citizen petition process to delay …

    • FDA’s Quality Metrics Program: The Sound of SilenceMarch 19th, 2018

      Back in 2015, FDA stated its intention of initiating a voluntary quality metrics reporting program (a cornerstone of FDA’s framework for building quality into drug products) and, in July of that year, announced the publication of a draft Quality Metrics Guidance. We blogged about the …

    • The PEW Charitable Trusts Releases Report on the State of Human Drug Compounding by Traditional Pharmacies and Outsourcing FacilitiesFebruary 27th, 2018

      Today the PEW Charitable Trusts released a detailed report on the general state of pharmacy compounding of human drug products in the United States. The Report focuses on compounding pharmacies, but addresses both sterile and non-sterile compounding regulation by states.  The Report also touches on …

    • Are You Talking? Because CDRH Says It’s Listening (At Least If You Are In the Digital Health Space): Notes from A Two Day WorkshopFebruary 11th, 2018

      The Center for Devices and Radiological Health (CDRH) says it has a plan for fostering digital health innovation while reimagining the regulatory oversight to provide patients with access to safe and effective digital health products. One step in the plan is developing a Digital Health …

    • ACI’s Food Law Regulation Boot CampOctober 1st, 2017

      The American Conference Institute’s (“ACI’s”) Food Law Regulation Boot Camp is slated to take place at the Wyndham Grand Chicago Riverfront in Chicago, Illinois from November 13-15, 2017.  The conference is billed as a way to “[c]onnect the dots of food regulatory law and gain …

    • CDRH Issues Final Guidances Regarding Use of Real-World Evidence and Procedures for Advisory Committee MeetingsSeptember 13th, 2017

      It appears that CDRH has now resumed issuing guidances after not issuing any in the first six months of the new administration. In late August and early September CDRH has issued several final guidances, including “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical …

    • Rehearing Urged for Bad Ninth Circuit DecisionSeptember 10th, 2017

      In July, as reported here, the Ninth Circuit reversed the lower court’s decision to dismiss a False Claims Act (FCA) case against Gilead Sciences, Inc.  Not surprisingly, Gilead timely filed a petition for rehearing or rehearing en banc with the Ninth Circuit, and several groups submitted …

    • PhRMA and BIO Team Up Again to Challenge a State Drug Pricing LawSeptember 7th, 2017

      On September 1, 2017, two industry trade associations, Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Innovation Organization (“BIO”), jointly filed a civil action seeking declaratory and injunctive relief against the Nevada Governor and Director of the Nevada Department of Health and Human Services …