• where experts go to learn about FDA
  • Kalie E. Richardson

    • FDA Takes Another Small Step to Increase Naloxone AccessOctober 13th, 2022

      While COVID-19 and monkeypox may be the public health emergencies garnering much of our current attention, we have been in the midst of another declared public health emergency for nearly 5 years: the opioid crisis.  FDA recently issued a Guidance (Exemption and Exclusion From Certain …

    • President Biden Gives the Green Light for Significant Marijuana ReformOctober 10th, 2022

      On October 6, President Joe Biden issued a brief but sweeping three-step statement towards reforming Federal marijuana law.  The president’s first step was a pardon of all prior federal offenses of simple marijuana possession and a direction to the Attorney General to develop an administrative …

    • The Wait is — Almost — Over: The Long-Anticipated Proposed Rule for Drug Wholesale Distributors and 3PLs is Out: Comments Due in 120 DaysFebruary 4th, 2022

      FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”).  The Drug Supply Chain Security Act (“DSCSA”), enacted back in November 2013, directed FDA to create national licensure standards for wholesale distributors and 3PLs within …

    • Pharmacy Owner Pleads Guilty to Federal Charges for Illegally Administering COVID-19 Vaccines to Children Under 12September 29th, 2021

      On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 …

    • Is Facebook Ghosting Pharma?September 1st, 2021

      In what appears to be an “about face” in terms of Facebook’s historical wooing of big pharma (are we the only ones that immediately thought, “More Cowbell” when seeing that headline?  You can thank us for that 5 minute rabbit hole later), the social media …

    • Minnesota Proposes to Reduce Opioid Product Registration Fees Related to HospitalsJune 29th, 2021

      A recent proposed amendment to Minnesota’s Opiate Product Registration Fee appears intended to ensure continued availability of certain opiate products at hospitals.  On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services …

    • New York Opioid Stewardship Act: Take 2 from the Second CircuitSeptember 16th, 2020

      On Monday, September 14, the United States Court of Appeals for the Second Circuit reversed the December 2018 opinion from the United States District Court for the Southern District of New York that invalidated the New York Opioid Stewardship Act (OSA).  In Association for Accessible …

    • State COVID-19 Response: Medical Marijuana and TelemedicineApril 7th, 2020

      State regulators across the healthcare professions continue to issue a number of guidances and waivers as part of the larger COVID-19 response.  We have previously blogged on a number of waivers issued by state pharmacy regulators in connection with COVID-19 response related to pharmacy staffing …

    • Update: State Controlled Substance Pharmacy Law Waivers and COVID-19 ResponseApril 2nd, 2020

      We previously blogged on a number of pharmacy law waivers issued by state pharmacy regulators in response to COVID-19.  Waivers are being updated and added to state pharmacy websites daily to address the constantly changing public health and regulatory landscape.  This blog post addresses a …

    • State Regulators Issue Pharmacy Law Waivers in COVID-19 ResponseMarch 30th, 2020

      As part of a larger COVID-19 outbreak response effort, many state pharmacy regulators have issued waivers or temporary suspensions of certain pharmacy laws. The California State Board of Pharmacy, State of Ohio Board of Pharmacy, Pennsylvania Department of State, and Texas State Board of Pharmacy …

    • In an Unusual Administrative Law Development, DOJ’s OLC States That FDA Has No Regulatory Authority Over Articles Used in Lawful ExecutionsMay 20th, 2019

      In a document as interesting for the “why” as the “what,” the Department of Justice, Office of Legal Counsel (“OLC”) recently issued a memorandum legal opinion concerning “Whether the Food and Drug Administration Has Jurisdiction over Articles Intended for Use in Lawful Executions.” The issuance of …

    • CMS Proposes Rule to Reduce Drug Costs Under Medicare Part D and Medicare AdvantageDecember 4th, 2018

      On November 30, CMS published in the Federal Register a proposed rule on Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. This proposal is the latest in a series of CMS actions to implement the HHS Blueprint to Lower …

    • 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 …

    • Congress Expands Sunshine ReportingOctober 9th, 2018

      Last Wednesday, October 3, a wide-ranging opioid bill cleared its last legislative hurdle by passing the Senate, and is expected to be signed by the President in the near future. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients …