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Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion
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I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug Promotions & Trends
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
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On February 17, Daniel Russo, a Long Island resident, pleaded guilty in federal court in Brooklyn to multiple charges in connection with illegally distributing oxycodone. Russo faces decades in federal prison when he is...more
A plutocratic clan has upped its ante by $1.5 billion in an apparently successful bet that using bankruptcy courts, mediation, and offering to settle giant claims in the opioid abuse and drug overdose crisis will be cheaper...more
In a landmark opioid painkiller case, a federal bankruptcy judge has approved what potentially may be a $10-billion settlement. It included a plutocratic clan winning sweeping protections from further civil lawsuits by...more
When accomplished folks who have racked up awards like Oscars, Emmys, and Pulitzers provide their frank appraisal of the roles of Big Pharma, federal regulators, and law enforcement in the opioid abuse and drug overdose...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
So, who doesn’t daydream a little about money? Maybe even big money. Just imagine a scenario where, if you could put up $3,000, you could keep $13,000, or if you forked over $30,000, and walked away with $130,000? So how...more
For those who get a rise out of following the plight of plundering plutocrats, forget about pop culture shows like Succession, Dynasty, or Empire. Instead, it may be worth peeking in on the true-life Sackler family saga. It...more
Fintech firm Stripe Inc., which “allows internet companies and online marketplaces to accept credit cards for their goods and services and pay out money to the people and firms that sell on their platforms,” just wrapped a...more
The Bureau of Workers’ Compensation (BWC) recently announced that it will stop covering payments for OxyContin, as well as generic sustained-release oxycodone tablets, to workers who sustain work-related injuries on or after...more
OxyContin-maker Purdue Pharma and its owners, the Sackler family, reached a deal this week with the state of Oklahoma in which they will pay “$270 million to avoid going to a state court trial over the company’s role in the...more
OxyContin maker Purdue Pharm is prepping for a possible bankruptcy filing “as it seeks to contain liability from hundreds of lawsuits alleging it fueled the nation’s opioid epidemic.” Officially, the company went on the...more
On May 16, 2018, the U.S. Attorney’s Office for the Southern District of Georgia announced that it had entered into the “largest hospital drug diversion civil penalty settlement in U.S. History” in the amount of $4.1 million...more
This is the first episode in a series focused on the legal issues surrounding the nationwide opioid crisis. To begin the series, Carla DewBerry discusses the laws and regulations impacting health care providers caring for...more
A U.S. Senate Committee has ripped Big Pharma for making millions of dollars in pernicious payments to patient advocacy groups, so they could legitimize and assist in promoting powerful prescription painkillers, a practice...more
Purdue Pharma, which built a multi-billion-dollar family empire, in part, by overcoming doctors’ resistance to prescribing powerful painkillers like its own powerhouse OxyContin, has decided to curb its quarter-century of...more
Case Name: Purdue Pharma L.P., v. Mylan Pharms. Inc., 15-1155-RGA-SRF, 2017 U.S. Dist. LEXIS 28460 (D. Del. Mar. 1, 2017) (Fallon, M.J.). Drug Product and Patent(s)-in-Suit: OxyContin® (oxycodone hydrochloride); U.S....more
OxyContin in two decades not only has become a highly profitable, exceedingly popular prescription, it also has become one of the nation’s most abused painkillers-for a crucial reason, the Los Angeles Times says. The paper...more
Addressing product-by-process limitations and inherent anticipation issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling that the asserted claims of Purdue Pharma’s patents covering...more
The opioid crisis, an ever-increasing focus of the Obama administration and 2016 Presidential Primary field, has highlighted the efforts of the Drug Enforcement Administration (DEA) and the Department of Justice (DOJ) to...more
The nominee for the top job at the U.S. Food and Drug Administration is being held hostage by Congress until the agency agrees to revamp its approval process for opioid painkillers....more
Amid a recent surge in opioid-related deaths in Massachusetts, with over 1,200 accidental deadly overdoses last year, the Senate passed legislation on Thursday, October 1, that is designed to fight the epidemic on various...more
Case Name: Purdue Pharma L.P. v. Amneal Pharms., LLC, Civ. Nos. 04-Md-1603 (SHS); 13-cv-3372 (SHS), 2015 U.S. Dist. LEXIS 45967 (S.D.N.Y. Apr. 8, 2015) (Stein, J.) - Drug Product and Patent(s)-in-Suit: OxyContin®...more
- A Cautionary Tale: Takes One to Know One - Treatment with Drugs - Treatment with Exercise - Treatment with Modalities - Treatment with Injections - Quality Control for Pain Relief - Excerpt from Introduction:...more