False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
340B Drug Pricing Program Compliance
Podcast: Post-Dobbs Access to Reproductive Health Care and Abortion-Inducing Drugs - Diagnosing Health Care
Podcast: Impact of COVID-19 on Pharmacist Scope of Practice: Before and After the PREP Act - Diagnosing Health Care
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Edible Bites Episode 3: Cannabis and Life Sciences Video Webinar Series
Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
Drug Pricing Initiatives During the Trump Presidency
Bill on Bankruptcy: AMR Make-Whole Opinion Vulnerable on Appeal
As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more
As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more
The Kingdom of Saudi Arabia issued Royal Decree number M/195 dated 03/09/1446H (corresponding to 03/03/2025G) (the “Royal Decree”), allowing foreign investment in retail pharmacies. This is a significant development as...more
Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more
The future direction of the Alabama Board of Pharmacy (“the Board”) hangs in the balance following recent legislation that, if passed, would revise many portions of the state Pharmacy Practice Act. House Bill 123, sponsored...more
Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more
A recent federal policy update and Quebec legislative changes are changing the healthcare landscape in Quebec, and may impact a variety of businesses operating in this sector....more
Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more
A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
On April 15, 2024, the Kentucky Board of Pharmacy (“Board”) posted a suite of proposed non-resident pharmacist rules that will require any pharmacist working in another state and who provides services on a Kentucky citizen’s...more
On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more
Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
On February 6, 2024, the New York State Department of Financial Services (“DFS”) released “pre-proposed” consolidated rulemaking related to the business practices of Pharmacy Benefit Managers (“PBMs”) licensed to operate in...more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. Ohio legislators are busy writing a marijuana law. STATES 2.0 makes an appearance in Congress. The Department of...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more