False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more
In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more
Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more
Suboxone is a medication used to treat opioid addiction, containing buprenorphine and naloxone. While Suboxone is highly effective in helping individuals overcome opioid dependence, there have been concerns about its...more
F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more
On May 26, 2023, the Drug Enforcement Administration (DEA) published a final decision and order (the “Final Order”) affirming an Administrative Law Judge's (ALJ) August 29, 2019 recommendation (the “ALJ Order”) to revoke DEA...more
In Westfield National Insurance Co. v. Quest Pharmaceuticals, the Sixth Circuit held that two insurers owed no coverage obligations to Quest Pharmaceuticals in connection with 77 lawsuits filed against it alleging misconduct...more
In 2021, drug-related overdose deaths topped 107,000. Despite a nearly 50% decrease in opioid prescribing over the past decade, drug overdose mortality continues to trend in the wrong direction. In the face of these...more
Prompted by rising rates of overdose deaths, suicides and incidence of mental illness in at-risk populations, such as children, Congress has spent the better part of the year working in a bipartisan manner to develop and...more
In a shift from prior policy, the Centers for Disease Control and Prevention (CDC) proposed on February 22, 2022, new guidelines for prescribing opioid painkillers. The new guidance largely avoids figures on dosage strength...more
Patients who say they were injured by wealthy corporations must possess great fortitude as they seek justice in the civil system, as has been reaffirmed by the courts in California and Oklahoma that rejected separate cases...more
On July 6, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-113 titled “An Act Concerning Opioids” (PA 21-113), which establishes pilot programs to help serve persons with opioid use disorder in urban,...more
Health workers with legal prescribing privileges have gotten newly revised federal guidelines — once again — making it easier for them to help those addicted to powerful opioid painkillers by prescribing buprenorphine,...more
Members of the plutocratic Sackler clan have upped the ante yet again in a bankruptcy court bid to settle thousands of lawsuits targeting Purdue Pharmaceutical, the company long in the family’s grip and blamed for untold...more
While too many Americans struggle with skyrocketing prescription drug costs, so much so that a $10 insurance co-payment may be lethally dissuasive, Big Pharma firms are seeking billions of dollars in taxpayer-funded benefits...more
The opioid abuse and drug overdose crisis has tarred yet another of the nation’s business titans: McKinsey, a globally renowned consulting firm, has discovered that providing corporate clients sketchy advice about addictive,...more
The stain of the nation’s opioid abuse and drug overdose crisis has spread now to Bentonville, Ark., as federal prosecutors have sued Walmart, accusing the nation’s largest retailer of improperly allowing its pharmacists to...more
Heaps of ignominy are not in short order for parties that played sketchy roles in fostering the nation’s deadly opioid abuse and drug overdose crisis. The stain has spread now to one of corporate America’s most-favored...more
The Justice Department on Wednesday announced an $8.3 billion settlement with Purdue Pharma as part of a deal in which the company will plead guilty to criminal charges “related to its marketing of the addictive painkiller”...more
The civil justice system has scored a win in curtailing what once was a major maker of much abused and lethal prescription painkillers: Mallinckrodt, a global drug making giant, has agreed to send its opioids-making generics...more
In response to the opioid epidemic, many states, including Texas, created prescription drug monitoring programs to monitor high-risk patients and provider behaviors. The Texas Prescription Drug Monitoring Program (“PMP”) is...more
In a 63-page decision issued on Jan. 13, 2020, in Lebanon County Employees’ Retirement Fund v. AmerisourceBergen Corporation, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery found that stockholders of...more
On December 20, 2019, President Trump signed into law the National Defense Authorization Act for Fiscal Year 2020 (“NDAA 2020”), which includes numerous sanctions-related provisions. The law includes the previously introduced...more
Seyfarth Synopsis: In the latest development in the ultra-high stakes nationwide Prescription Opiate Litigation, the U.S. Court of Appeals for the Sixth Circuit recently granted the petition of six Ohio cities to appeal the ...more
The Drug Enforcement Agency’s National Prescription Drug Take Back Day is tomorrow: Saturday, October 26. This day has evolved over the years to address the growing opioid crisis, including misuse and abuse of unused...more