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
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
In 2020, over 142 million prescriptions for opioid medications were filled in the U.S. That same year, 16,416 people died from overdoses on prescription opioids—a 376% increase from 1999....more
Ohio is eliminating the Ohio Board of Pharmacy’s (“BoP”) regulation of office-based opioid treatment (“OBOT”) clinics. Ohio law currently requires any clinic where a prescriber provides treatment for opioid dependence or...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
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
Last week, the Supreme Court (Court) heard oral arguments in companion cases Ruan v. United States and Kahn v. United States, concerning the application of the Controlled Substances Act (“CSA” or “the Act”) to medical...more
As the opioid abuse and drug overdose crisis rages, experts - after decades now of experience with powerful painkillers - continue to struggle with their proper handling and prescribing. The federal Centers for Disease...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
The Canadian Agency for Drugs and Technologies in Health (CADTH) published an interesting new report on January 29, 2021 about Health Technology Trends to Watch. The report identifies the following list of emerging trends...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
Consulting standard-bearer McKinsey & Co. will pay $573 million to resolve state investigations and allegations related to its role “in helping ‘turbocharge’ opioid sales, a rare instance of it being held publicly accountable...more
The Justice Department handed Walmart a huge slap in the face last year with the filing of a comprehensive civil case alleging that Walmart knowingly distributed large quantities of opioids in disregard of the law that fueled...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
The official transition to a new administration and early Cabinet selections helped drive Wall Street to new highs on Tuesday, with the Dow topping 30,000 for the first time and the S&P 500 up 1.6% to another new high, too....more
The DEA struggles to balance the pressing need to provide pain relief for those suffering from the novel coronavirus with the ongoing effort to reduce the opioid epidemic in the United States. I. Overview on the DEA and the...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
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 granted the petition for writ of mandamus brought by twelve...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
DUSTING SPRAY DEATHS AND INJURIES - Robins Kaplan LLP is investigating and litigating “dusting” cases, which arise when someone inhales—or “huffs”—compressed gas dusting spray for its intoxicating effects while driving and...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