• where experts go to learn about FDA
  • Serra J. Schlanger

    • Advertising Laboratory Tests: Change on the Way in MarylandApril 12th, 2019

      The 2019 Maryland Legislative Session closed on April 8th with an exciting development related to laboratory testing.  As we previously reported (see here), Maryland law currently prohibits directly or indirectly advertising or soliciting for medical laboratories.  Two bills were introduced earlier this year to address …

    • Laboratories Beware of EKRAMarch 5th, 2019

      On October 24, 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act was signed into law (the Act’s text is available here).  The SUPPORT Act includes a number of provisions to address the ongoing opioid crisis, such …

    • New Efforts to Expand Access to Laboratory Tests in MarylandFebruary 6th, 2019

      Readers who work with laboratory tests are likely aware that such tests can be subject to regulation by FDA, CMS, and individual states. A few state laws, particularly those in Maryland, New York, New Jersey, and Rhode Island, currently constrain how some laboratory tests are …

    • AdvaMed Updates Code of EthicsJanuary 17th, 2019

      On January 9, 2019, the Advanced Medical Technology Association (AdvaMed) announced updates to its “Code of Ethics on Interactions with Health Care Professionals” (Code).  The Code was last updated in 2008; the newest updates will become effective on January 1, 2020. The Code includes new sections …

    • Vermont Report Finds that the Costs of Prescription Drug Importation May Outweigh SavingsJanuary 15th, 2019

      As we previously reported, Vermont Governor Phil Scott signed a new law in May 2018 allowing for the wholesale importation of prescription drugs from Canada into Vermont.  Vermont’s Agency of Human Services (VAHS) recently issued a report containing the Agency’s preliminary design for a “Canadian …

    • Pharmacogenetic Tests: Recent FDA Authorization for One and Warnings about OthersNovember 21st, 2018

      On October 31, 2018, FDA announced that 23andMe could market its Personal Genome Service Pharmacogenetic Reports test (the “23andMe test”) as a direct-to-consumer test for providing information about genetic variants that may be associated with medication metabolism.  The 23andMe test was reviewed using the de …

    • New Vermont Law Seeks to Allow Wholesale Importation of Drugs from CanadaMay 22nd, 2018

      On May 16, 2018, Vermont Governor Phil Scott signed Senate Bill 175, which allows for the wholesale importation of prescription drugs from Canada into Vermont.  The new law directs the Vermont Agency of Human Services (VAHS) to design a wholesale prescription drug importation program that …

    • 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. …

    • CMS Finalizes National Coverage Determination for Next Generation Sequencing TestsMarch 20th, 2018

      On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a new National Coverage Determination (NCD) for Next Generation Sequencing (NGS) tests.  The granting of the new NCD resulted from the FDA – CMS Parallel Review of Foundation Medicine, Inc.’s FoundationOne CDx™ …

    • Oregon Jumps on the Drug Pricing Transparency BandwagonMarch 15th, 2018

      On March 13, 2018, Oregon became the latest state to enact a law focused on transparency in drug pricing (see our roundup of other recent state laws). The Prescription Drug Price Transparency Act, H.B. 4005, places new reporting requirements on drug manufacturers related to price …

    • New Jersey Finalizes New Limits on Pharmaceutical Manufacturer Gifts and Payments to PrescribersJanuary 17th, 2018

      As we previously reported, in October 2017, the New Jersey Attorney General and Division of Consumer Affairs issued a proposed rule in response to concerns about the amount of money being paid to prescribers in the state of New Jersey. On December 22, 2017, the …

    • Continued Interest in Drug Categorization – OIG Finds Ten Potentially Misclassified Drugs May Have Led to $1.3 Billion in Lost Medicaid RebatesJanuary 4th, 2018

      On December 20, 2017, the Department of Health and Human Services, Office of Inspector General (OIG) published a report entitled “Potential Misclassifications Reported by Drug Manufacturers May Have Led to $1 Billion in Lost Medicaid Rebates.” This report is the result of Congress’ September 2016 …

    • New Jersey Proposes New Limits on Manufacturer Gifts and Payments to PrescribersOctober 30th, 2017

      On October 2, 2017, the New Jersey Attorney General and Division of Consumer Affairs published Proposed New Rule N.J.A.C. 13:45J, Limitations On and Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers.  According to the preamble, the proposed rule responds to a concern …

    • OIG Issues an Advisory Opinion on Providing Replacement ProductAugust 28th, 2017

      In an advisory opinion posted on August 25, 2017, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) determined that enforcement action would not be taken against a drug manufacturer’s proposal to replace products that require specialized handling that …

    • 21st Century Cures Act: Three Notable Health Care Provisions and a Reminder to Sign Up for HP&M’s Two Complimentary WebinarsJanuary 5th, 2017

      To complete our initial summaries (see here, here, and here) of the 21st Century Cures Act (Act), we want to highlight the three health care provisions included in Title IV – Delivery and Title V – Savings that we think are of most relevance to …