News & Analysis as of

Marketing Pharmacies

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

Oberheiden P.C. on

Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more

Epstein Becker & Green

FDA PDMA Guidance in Response to COVID-19 Pandemic

Epstein Becker & Green on

The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.  The Prescription Drug Marketing Act of 1987 (PDMA)...more

Bass, Berry & Sims PLC

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

Hogan Lovells

Updates on the newest regulatory legislation (Royal Decree 717/2019) in Spain

Hogan Lovells on

On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...more

Smart & Biggar

Rx IP Update - February 2019

Smart & Biggar on

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

Baker Donelson

OIG Advisory Opinion 18-01: Excluded Individual May Serve as Marketing Liaison to LTC Pharmacies

Baker Donelson on

In OIG Advisory Opinion 18-01, published February 27, 2018, the OIG concluded a proposed employment arrangement between an excluded individual and a for-profit company selling discounted emergency medications to long term...more

Patrick Malone & Associates P.C. | DC Injury...

Why do drug prices soar? Blame PBJs, PBMs, weak regulators, and CME

What do PBJs, PBM “black boxes,” industry friendly advisory panels, and CME (aka doctor training programs) all share in common? They’re blamed for contributing to Big Pharma’s skyrocketing prices—and it’s worth diving into...more

Holland & Knight LLP

Healthcare Law Update: December 2016

Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Mintz - ML Strategies

Transparency in Drug Pricing: Issues to Consider from the Research Lab to the Consumer

Mintz - ML Strategies on

Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more

Thomas Fox - Compliance Evangelist

The Drugstore Cowboy And Compliance

One does not have to look very far in the business world to come across the phrase “Know Your Customer.” A company certainly needs to know if an entity that it may sell products or provide services to will pay for those...more

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