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Marketing Pharmaceutical Industry Healthcare

Troutman Pepper

2024 Mid-Year Review: State AGs Shaping Regulatory Landscapes

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In 2024, the landscape of state attorneys general (AGs) is poised for significant change, with numerous elections and regulatory actions reshaping priorities and enforcement strategies. This dynamic environment reflects the...more

Nelson Hardiman, LLP

Cracking the Whip: The FTC’s Clampdown on Healthcare Marketing

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The American reverence for entrepreneurial spirit and free enterprise is reflected in the profound influence of capitalism on our healthcare system. In contrast to many other advanced industrialized countries with state-run...more

Troutman Pepper

8 Ways Life Sciences Cos. Can Adapt to the Social Media Era

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Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more

Knobbe Martens

FDA Issues Long-Overdue Regulations on Direct-To-Consumer Advertisements for Prescription Medications

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On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers. The FDA first issued its proposed rule in 2010, which subsequently went through three public comment...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more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

Gardner Law

Back on the Case: FDA Issues Fresh Enforcement Letters

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After two years of decreased enforcement activity (with an out-sized portion of activity being COVID-19-related), the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued several Untitled...more

Arnall Golden Gregory LLP

It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product

“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more

Arnall Golden Gregory LLP

Out of Touch: FDA Takes Exception With Drug Company’s Promotion for Topical Drug Product

Who doesn’t remember Hall and Oates’ 1984 hit, “Out of Touch?” Perhaps, reviewers in the Food and Drug Administration’s Office of Prescription Drug Promotion were humming this song when it recently issued an Untitled Letter...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Manatt, Phelps & Phillips, LLP

[Webinar] Digital Health: Disruptive Technology or Just a Disruption? - October 23rd, 1:00 pm ET

The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more

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

Cracking down on medical hype could cut $30 billion in wasted costs

When reformers look for ways to slash the ever-higher costs of American medical care, one line item should leap from television screens, print pages, and radio broadcasts: How does the nation benefit from medical enterprises...more

Hogan Lovells

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

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Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more

Hogan Lovells

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

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The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

Holland & Knight LLP

Healthcare Law Update: December 2016

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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

Stinson LLP

FDA Launches New Webpage to Report Regulatory Misconduct

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Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

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

Why Industry Drug-Assistance Programs Are a Sham

You probably heard about the recent price hike for a drug critical to AIDS patients when the manufacturer sold it to an evil hedge fund manager who promptly marked it up 5,000%. This prompted Los Angeles Times columnist...more

Mintz

2011-2012 Massachusetts Legislative Session

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The formal legislative session for 2011-2012 concluded on July 31st. The session was defined by landmark legislation in healthcare cost containment, economic development, energy, and consumer protection. The Legislature will...more

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