News & Analysis as of

Patients Pharmaceutical Industry

Stark & Stark

Guide to Ozempic/Wegovy Vision Loss Lawsuits and Settlements

Stark & Stark on

What types of eye injuries does Ozempic/Wegovy cause? Ozempic/Wegovy are two of the most common weight-loss medications known as GLP-1 drugs. Other  GLP-1 drugs include Mounjaro, Rybelsus, Saxenda, Victoza, Trulicity, and...more

McDermott Will & Schulte

New EO Targets Prescription Drug Costs – and Drug Manufacturers, Hospitals, and Health Centers

On April 15, 2025, President Trump signed an executive order (EO) aimed at addressing the cost of prescription drugs. This EO, titled “Lowering Drug Prices by Once Again Putting Americans First,” outlines specific directives...more

King & Spalding

OIG Issues a Favorable Advisory Opinion to a Pharmaceutical Manufacturer Regarding Free Transportation, Lodging and Support for...

King & Spalding on

On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more

Searcy Denney Scarola Barnhart & Shipley

Side Effects of Prescription Drugs: What You Should Know

Many prescription drugs have side effects. In fact, drug companies frequently include a list of side effects on their drugs’ labels and packaging (not because they want to, but because they are required to do so under federal...more

McDermott Will & Schulte

California Ballot Proposition 34 Targets Spending by Certain 340B Covered Entities

McDermott Will & Schulte on

Proposition 34 requires certain California healthcare providers to spend at least 98% of their net drug sale revenue on direct patient care. The measure targets certain providers who benefit from a federal drug discount...more

Sheppard Mullin Richter & Hampton LLP

California Votes to Impose 340B Spending Restrictions on Targeted 340B Providers

California is poised to pass a ballot measure aimed at imposing 340B spending restrictions for certain healthcare entities participating in the 340B Program who have historically engaged in spending that is not directly...more

Bass, Berry & Sims PLC

Hospital Faces Serious Patient Lawsuits Stemming from Drug Diversion

At least two private civil lawsuits have been filed against Asante Rogue Regional Medical Center in Medford, Oregon, in connection with a fentanyl diversion and related indictment of a former nurse. A wrongful death suit...more

Napoli Shkolnik

What Is Polypharmacy And Why Should You Care?

Napoli Shkolnik on

Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts....more

Arnall Golden Gregory LLP

OIG Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more

Arnall Golden Gregory LLP

OIG Greenlights Manufacturer’s Travel-Related Financial Assistance Offering

On June 17, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable Advisory Opinion 24-03 (“AO 24-03”) involving a pharmaceutical manufacturer’s proposed patient...more

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

Foley Hoag LLP on

On April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...more

Dentons

Ep. 4 - Ozempic, Wegovy, and the New Compliance Risks for Providers

Dentons on

Diabetes and obesity drugs have skyrocketed in popularity as of late. According to a report released by Trilliant Health in September 2023, healthcare providers in the United States wrote more than 9 million prescriptions for...more

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

McDermott Will & Schulte

This Week in 340B: November 2023

This weekly series provides brief summaries 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

Quarles & Brady LLP

District Court Allows for Expanded Interpretation of Eligible Patient in Impactful 340B Program Ruling

Quarles & Brady LLP on

In a decision likely to send shockwaves through the 340B Program space, the United States District Court of South Carolina recently provided a favorable ruling to 340B-participating covered entities hoping to take a more...more

Bass, Berry & Sims PLC

Court Guts 340B Program “Patient” Definition, Opening Door to More 340B Use

Bass, Berry & Sims PLC on

On November 3, a federal district court issued a monumental decision endorsing an expansive view of who is a “patient” of a 340B program covered entity eligible to receive a 340B drug. In Genesis Healthcare, Inc. v. Becerra,...more

Quarles & Brady LLP

HRSA Notice Provides Clarity on 340B Child Site Registration Requirements

Quarles & Brady LLP on

After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more

McDermott Will & Schulte

This Week in 340B: September 2023 #3

This weekly series provides brief summaries 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

Quarles & Brady LLP

Oklahoma Patient's Right to Pharmacy Choice Act Preempted by ERISA

Quarles & Brady LLP on

On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit issued an opinion in Pharmaceutical Care Management Association v. Glen Mulready, in his official capacity as Insurance Commissioner of Oklahoma, Oklahoma...more

McDermott Will & Schulte

This Week in 340B: July 2023 #4

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Sheppard Mullin Richter & Hampton LLP

PBM Practices Receive Increased Federal Scrutiny

Though many recent reforms regarding prescription drug affordability have been focused on manufacturers and health plans, pharmacy benefit managers (“PBMs”) are also the focus of increased attention from federal policymakers...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Legislative Efforts to Remove Impediments to Biosimilar Approvals and Marketing

Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more

McDermott Will & Schulte

This Week in 340B: February 2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Foley & Lardner LLP

USPTO-FDA Listening Session — Voices from Patient and Patent Advocates

Foley & Lardner LLP on

On January 19, 2023, the U.S. Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) held a “listening session” focusing on USPTO-FDA collaboration initiatives proposed pursuant to President Biden's...more

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes from the 41st Annual J.P. Morgan Healthcare Conference

I was struck on the first day of the 41st Annual J.P. Morgan Healthcare Conference by Sanjay Doddamani (CEO of UpStream Healthcare) saying that “Health is a state of independence.” A simple statement, but a very profound and...more

78 Results
 / 
View per page
Page: of 4

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide