News & Analysis as of

Health Care Providers Pharmaceutical Industry Marketing

Nelson Hardiman, LLP

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

Nelson Hardiman, LLP on

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

Mintz - Health Care Viewpoints

Guidance from FDA Clarifies a Key Issue for Industry: Non-Promotional Presentations About Unapproved Uses of Medical Products Can...

U.S. health care attorneys, investors, and industry stakeholders are very familiar with the well-worn mantra that prescription drug and medical device companies are not allowed to “market” or “promote” their...more

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

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

Fox Rothschild LLP

OIG Issues Special Fraud Alert On Speaker Programs

Fox Rothschild LLP on

Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...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

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...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

Robinson+Cole Health Law Diagnosis

Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...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

Mintz - Health Care Viewpoints

Warner Chilcott HIPAA Lesson Revisited – Mass. Physician Convicted of Criminal Violation

Back in late 2015, we blogged about the interesting twist in the $125 million Warner Chilcott settlement that a Massachusetts physician had been criminally charged with violating the Health Insurance Portability and...more

Hogan Lovells

New Jersey Joins Wave of States Proposing New Rules for Drug Marketing and HCP Interactions

Hogan Lovells on

Drug manufacturers are once again facing new state limits on marketing and interactions with healthcare providers. Manufacturers should review the new laws and regulations carefully, consider how they might engage with the...more

Cooley LLP

Blog: Comments to Draft Chicago Pharmaceutical Sales Representative License Rules Due April 2, 2017

Cooley LLP on

As previously discussed, pharmaceutical sales representatives that conduct business in the City of Chicago will need to be licensed as of July 1, 2017. The Commissioner of the Chicago Department of Public Health (CDPH) and...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

Cooley LLP

Blog: Pharmaceutical Reps Now Required to be Licensed in the City of Chicago; Includes Code of Ethics & Potential Transparency...

Cooley LLP on

Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for...more

Mintz - Health Care Viewpoints

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

Snell & Wilmer

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

Snell & Wilmer on

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

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