News & Analysis as of

Health Constitutional Law Consumer Protection

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Mobile targeting: A ‘secret weapon’ for good or ill?

by Thompson Coburn LLP on

It’s an advertiser’s dream — the ability to target customers through their mobile devices, right to down to where they are and what they are doing. But can such precisely targeted messages become a recipient’s nightmare?...more

Antitrust Not Always Available in Competitor Disputes in the Healthcare Sector

The antitrust injury and antitrust standing defenses/doctrines are alive and well in healthcare.  A recent case, SCPH Legacy Corp. et al. v. Palmetto Health et al., shows that a competitor is not always the most legally...more

House Republicans and Trump Administration File Joint Motion to Delay Suit Challenging Obamacare Subsidies

by Ruder Ware on

An interesting development transpired Tuesday, February 21, 2017 in a case pending in Federal District Court in the District of Columbia that challenges subsidy payments from the Federal Treasury to support Obamacare. The...more

Litigation Alert: The Third Circuit Holds That Allegations That Personal Information Was Improperly Disclosed in Violation of the...

by Fenwick & West LLP on

Last week, the Third Circuit held that allegations of the unauthorized disclosure of personal information in violation of the Fair Credit Reporting Act (FCRA) constituted a de facto injury sufficient to confer standing at the...more

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

TCPA Update - October 2016

by Mintz Levin on

We are pleased to present the latest edition of Monthly TCPA Digest, bringing you insights on TCPA regulatory and legislative updates, class action developments, and trends. If you have suggestions for content you would like...more

Upcoming FDA Public Meeting on Speech and Medical Products

by Reed Smith on

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” ...more

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

"Privacy & Cybersecurity Update - August 2016"

In this edition of our Privacy & Cybersecurity Update, we highlight guidance issued by the Irish data protection authority regarding the use of location data, as well as the FTC's request for comment on its Standards for...more

Settle or Fight FDA/DOJ Off-Label Use Allegations? WSJ Editorial Looks at Vascular Solutions Trial Win and Asks What's Next?

by King & Spalding on

In an editorial this weekend entitled “No Justice for Business,” The Wall Street Journal hailed a recent trial win by medical device maker Vascular Solutions, Inc. (VSI) as a “victory for common sense and the First Amendment”...more

Virginia’s Certificate of Need Laws May Stay, Fourth Circuit Says

by McDermott Will & Emery on

On January 21, the U.S. Court of Appeals for the Fourth Circuit upheld Virginia’s Certificate of Need (CON) laws, ruling that the scheme does not illegally discriminate against out-of-state health care providers. See Colon...more

Ruling on Economic Favoritism Puts ‘NC Dental’ Back in Spotlight

by BakerHostetler on

In a recent opinion, a divided panel of the U.S. Court of Appeals for the Second Circuit ruled that an economic regulation passed by a state agency solely to protect one group from competition would not violate the...more

One Small Step for Amarin & One Giant Leap for Pharmaceutical Companies? - Only Time Will Tell

Friday’s ruling in Amarin Pharma, Inc. v. United States Food & Drug Administration is a monumental event. It signals the dawn of a new era for prescription drug promotion....more

US District Court for the District of New Jersey Dismisses Data Breach Class Action on Lack of Article III Standing

In re Horizon Healthcare Services, Inc. Data Breach Litigation was a class action law suit arising out of the theft of two of Horizon’s password-protected laptops that contained the personal information of more than 839,000...more

The 'Palmetto Put-Down' Endangers Drug Cos. Nationwide

by Pepper Hamilton LLP on

On Feb. 25, 2015, nearly two years after argument, the South Carolina Supreme Court directed entry of a $136 million judgment against Janssen Pharmaceuticals Inc. These civil penalties stemmed from a suit brought by the...more

FDA Proposed Rule in Flux?

by Morrison & Foerster LLP on

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Un test sulle ipotesi delle proiezioni a medio-lungo termine della spesa farmaceutica

by Nicola Carmine Salerno on

We use the same methodology, that Ecofin-Oecd apply for projecting expenditure in the medium-long term, to reconstruct expenditure in the medium-long past. It is possible to compare the effective expenditure with the...more

NFLPA Investigates Buccaneers on MRSA Issue

by Anthony Caruso on

NFLPA Investigates Buccaneers on MRSA Issue by Anthony Caruso on September 11, 2013 The Tampa Bay Buccaneers may be in hot water over whether the team communicated the outbreak of MRSA - a dangerous bacteria resistant...more

Second Circuit Vacates Misbranding Conviction for Pharmaceutical Representative on First Amendment Grounds

by Holland & Knight LLP on

In United States v. Caronia, No. 09-5006-cr, slip op. (2d Cir. Dec. 3, 2012), the U.S. Court of Appeals for the Second Circuit held that "the government cannot prosecute pharmaceutical manufacturers and their representatives...more

Lo sviluppo delle copie economiche dei farmaci off-patent e il bottleneck della distribuzione al dettaglio

by Nicola Carmine Salerno on

Lo sviluppo delle copie economiche dei farmaci off-patent e il bottleneck della distribuzione al dettaglio. Brevi riflessioni sull'Italia...more

Le farmacie nel Diritto dell'Economia

by Nicola Carmine Salerno on

Nel dibattito che accompagna i tentativi di riforma degli esercizi farmaceutici e della distribuzione del farmaco si continua, in maniera pretestuosa, a far riferimento a un presunto contrasto tra da un lato le indicazioni...more

Commento di Nicola ad articolo di Luisa Grion su la Repubblica

by Nicola Carmine Salerno on

Il copay che può far bene alal sanità e al Federalismo (di Nicola C. Salerno) data = 20 Dicembre 2010...more

La regolamentazione delle farmacie in Italia (Fabio Pammolli e Nicola C. Salerno, CeRM, 12 Novembre 2010)

by Nicola Carmine Salerno on

All’indomani dell’audizione del Presidente dell’Agcm Antonio Catricalà in Commissione Igiene e Sanità del Senato, questo Wp fa il punto sullo stato della distribuzione al dettaglio del farmaco...more

32 Results
|
View per page
Page: of 2
Cybersecurity

Follow Health Updates on:

"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:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.