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
Share on Twitter Print Share by Email Share Back to top In spring 2025, the Food and Drug Administration (FDA) resolved and ended the GLP-1 medications shortage, subsequently releasing declaratory orders that neither...more
The New York State Department of Health (DOH) has published a set of Frequently Asked Questions (FAQs) to provide guidance on the "Disclosure of Material Transactions" law that took effect on Aug. 1, 2023. Pursuant to Article...more
The FDA released a Declaratory Order on December 19th re-evaluating and essentially re-instituting its previous position on the tirzepatide shortage, declaring the shortage resolved. As a bit of history, on October 2, 2024...more
On September 13, the Alaska Board of Pharmacy (Board) issued a notice summarizing a regulatory update stating that pharmacies, wholesale drug distributors, outsourcing facilities, third-party logistics providers, and...more
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ... ...more
On July 13, the Department of Health & Human Services (HHS) Office for Civil Rights (OCR) issued guidance to retail pharmacies that refusing to dispense a prescribed medication or making a determination on the suitability of...more
Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more
This month, a working group within the Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN) has reviewed and highlighted “some of the potential challenges regarding adopting biosimilars into clinical...more
And employers will like it. NOTE FROM ROBIN: This is the text of a Legal Bulletin that we sent out today. I am posting it here for those of you who don't subscribe to our bulletins. The U.S. Equal Employment Opportunity...more
Health Canada has recognized for many years that the current regulatory regime on drug sampling, which significantly restricts the distribution of drug samples to both consumers and health care professionals, is outdated. For...more
The coronavirus (COVID-19) outbreak has led to a dramatic increase in the demand for, and a shortage of, hand sanitizer in the US. In response, the US Food and Drug Administration (FDA) and the US Treasury Department’s...more
The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19...more
The recent Centers for Medicare & Medicaid Services (CMS) memorandum to all Medicare Advantage Organizations, Part D Sponsors, and Medicare-Medicaid Plans (CMS Memo) does not provide any express relief for specialty...more
In the face of these unprecedented times brought on by the COVID-19 pandemic, pharmacies are grappling to find ways to protect patients and employees. In response, state officials and boards of pharmacies have reacted in a...more
Over the weekend, Massachusetts executive agencies issued an array of further guidance to the healthcare provider community regarding COVID-19. All orders and guidance are available at https://www.mass.gov/2019coronavirus....more
On Monday, March 9, 2020, the Centers for Medicare and Medicaid (CMS) released information on permissible flexibilities and obligations that are in effect during a disaster and emergency resulting from COVID-19....more
Rochester Drug Co-Operative, Inc. (“RDC”), one of the 10 largest pharmaceutical distributors in the United States, was recently charged along with its former Chief Executive Officer and former Chief Compliance Officer, for...more
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more
On June 12, the FDA issued guidance that clarifies its recommendations for certain product communications made by medical product manufacturers, packers, and distributors (collectively “firms”). The guidance, “Medical Product...more
On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities - Questions and Answers"...more
CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their...more
In January 2018, the U.S. Food & Drug Administration (FDA) published two guidance documents on Compounded Drug Products That Are Essentially Copies Of Approved Drug Products under Section 503A and Section 503B of the Federal...more