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  • Article

    FDA Will Not Implement User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements

    On January 16, 2008, the Food and Drug Administration (FDA) announced that it will not implement the Direct-to-Consumer Television Advertising User Fee Program because the necessary user fees for the program were not provided for in the Consolidated Appropriations Act of 2008 that President Bush signed into law on December 26, 2007.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Federal Trade Commission Votes To Reverse Stance On Pharmacy Benefit Managers

    On July 20, 2023, the Federal Trade Commission voted to withdraw its prior advocacy statements, studies and reports in support of pharmacy benefit managers.
    United StatesFood, Drugs, Healthcare, Life Sciences
Duane Morris LLP
Duane Morris LLP
  • Article

    First Cannabis Company Is Exchange-Listed Amid Uncertainty

    In a major positive step for the cannabis industry, the New York Stock Exchange last month listed a new real estate investment trust called Innovative Industrial Properties...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Following MOCRA's Enactment, Unpacking Litigation And Regulatory Risk For Cosmetics Brands

    On December 23, 2022, Congress enacted the first major statutory change to the Food and Drug Administration (FDA)'s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    FTC to Keep Healthcare and Pharmaceutical Sectors in Antitrust Crosshairs

    While the Trump Administration's antitrust policy is still developing, and most believe it will provide for less enforcement than antitrust policy under the Obama Administration, the Federal Trade Commission announced on Friday, March 31, that it has no intention of letting up on the healthcare and pharmaceutical sectors, where the FTC has been increasingly active over the past few years.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Government Cracks Down On Nursing Home Use Of Social Media

    On August 5, 2016, CMS published a Survey and Certification Memorandum urging State health departments to enforce violations by nursing homes in posting patient images on social media.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Healthcare False Claims Act Judgments/Settlements Lead Way In 2023

    The DOJ recently reported that two-thirds of the $2.68 billion in False Claims Act judgments and settlements in 2023, or $1.8 billion, came from the healthcare industry.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Inconsistency Among Courts Regarding Pleading Standards For Parallel Claims Involving Medical Devices

    Inconsistency Among Courts Regarding Pleading Standards for Parallel Claims Involving Medical Devices.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Kroger Agrees To Pay $1.37 Billion To State Attorneys General In Opioid Settlement

    On Monday, November 4, supermarket chain Kroger finalized a settlement agreement with dozens of state attorneys general requiring the company to pay a total of $1.37 billion...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Medical Director Arrangements Are Getting SNFs In FCA Hot Water

    Following up on a post from last week entitled "OIG Issues Fraud Alert on Medical Director Arrangements", the US Department of Justice announced today a $17 million settlement of a False Claims Act suit brought by the former CFO of a Miami nursing home network.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Nevada Supreme Court Imposes Duty To Warn On Pharmacists

    On November 23, 2011, the Nevada Supreme Court ruled in "Klasch v. Walgreen Co.", Nev. No. 54805, 1123(11), that a pharmacist who has knowledge that a patient may be at risk with respect to specific prescription drugs may be liable for failing to warn the patient or prescribing physician.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    New Limits On Regulatory Guidance From Federal Agencies

    A new policy recently issued by the Justice Department states that the Department will not use its enforcement authority to effectively convert agency guidance documents into binding rules.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    New York Adds Chronic Pain to Medical Marijuana List

    In a major development for New York, its Department of Health officially approved a regulation, first proposed in December, to allow people with "any severe debilitating pain that the practitioner determines degrades health and functional capability" that has lasted or is expected to last at least three months to access legal medical marijuana.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    OIG 2015 Work Plan – Home Health

    Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    OIG 2015 Work Plan – Hospice

    Recently, the Department of Health and Human Services Office of the Inspector General (the OIG) released its work plan for 2015.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    OIG Rescinds Advisory Opinion

    According to the OIG, the charity that sought and received the AO, breached two commitments made in its AO request.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Outlook For Life Sciences M&A: Industry Drivers Still Strong

    In a recent GEN Edge article, Duane Morris partner Rebecca Guzman discussed the state of M&A activity in the life sciences.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    PA Senate Passes Medical Marijuana Legislation Again

    Earlier this year , I wrote that 2015 might be the year that medical marijuana legislation is passed in Pennsylvania.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    Records Management

    I am about to work with the Illinois Hospital Association (IHA) on the third edition of IHA's Record Retention Reference.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
  • Article

    SCOTUS Strikes Down Texas Statute In Whole Woman's Health v. Hellerstedt; Duane Morris Amicus Brief Cited In Opinion (Pro Bono Newsletter | Summer 2016

    In a 5-3 decision, the U.S. Supreme Court in Whole Woman's Health v. Hellerstedt, No. 15-275, slip op. (June 27, 2016) reversed a decision of the Fifth Circuit and overturned as unconstitutional...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Duane Morris LLP
    Duane Morris LLP
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