The U.S. Food and Drug Administration's increasingly docile enforcement posture toward pharmaceutical advertisements may be emboldening drugmakers to take promotional liberties, a potentially perilous move despite the laid-back oversight. Here, experts share eight promotional pitfalls that pharma compliance officers need to know in today's enforcement environment.
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Feature

8 Promo Pitfalls Pharma Compliance Chiefs Need To Know

The U.S. Food and Drug Administration's increasingly docile enforcement posture toward pharmaceutical advertisements may be emboldening drugmakers to take promotional liberties, a potentially perilous move despite the laid-back oversight. Here, experts share eight promotional pitfalls that pharma compliance officers need to know in today's enforcement environment. Read full article »

Analysis

'On Sale' Ruling Shows Need For Earlier Patent Applications

The U.S. Supreme Court’s decision not to revive a Helsinn patent on the nausea drug Aloxi has clarified the scope of the on-sale bar under the America Invents Act and underscored the need for inventors to file their patent applications as early as possible. Read full article »

Walgreens Pays $269M In Milestone FCA Deals

Walgreens Boots Alliance Inc. has inked settlements worth $269 million to end False Claims Act allegations of egregious overbilling for various drugs, the U.S. Department of Justice said Tuesday, marking some of the largest FCA payouts ever by a retail pharmacy. Read full article »

Scientist Calls Studies Touted By J&J 'Dubious' At Talc Trial

An environmental health scientist pushed back Tuesday against Johnson & Johnson’s claims that multiple studies have shown no signs of asbestos in the talcum powder J&J used to make baby powder for decades, telling a California jury the FDA’s test methods in the 1970s were "dubious,” and others, inadequate. Read full article »

J&J To Pay States $120M For False Hip Implant Promos

A Johnson & Johnson unit will pay $120 million to end a wide-ranging investigation into whether it misled customers about the longevity and efficacy of its hip replacement devices, attorneys general in New York and Texas announced Tuesday. Read full article »

POLICY & REGULATION

Consumer Orgs Say NAFTA 2.0 Will Keep Drug Prices High

A group of 71 organizations sent a letter Tuesday to members of Congress urging them to remove provisions in the revised version of the North American Free Trade Agreement that would allow pharmaceutical companies to keep charging high prices, saying that pushing the same policies onto Mexico and Canada is not the solution to the drug pricing problem. Read full article »

FDA Releases Guidance On Clearing New Medical Devices

The U.S. Food and Drug Administration on Tuesday released final guidance outlining an updated pathway for bringing medical devices to market that uses objective performance criteria to show that the devices are safe and effective. Read full article »

LITIGATION

High Court Says AIA Did Not Change Meaning Of On-Sale Bar

The U.S. Supreme Court on Tuesday held the America Invents Act did not narrow the scope of the on-sale bar in patent cases, leaving unchanged a long-standing rule that confidential sales of an invention can be used to invalidate a patent. Read full article »

Hologic Settles Fujifilm's IP, Antitrust Mammography Suit

Hologic Inc. is settling out of a Delaware federal court lawsuit from Fujifilm Corp. accusing the medical technology company of patent infringement and maintaining an illegal monopoly over the U.S. market for mammography systems used to diagnose breast cancer. Read full article »

Valeant Urges Fed. Circ. To Revive Antifungal Patent

The Patent Trial and Appeal Board invalidated a patent covering Valeant Pharmaceuticals’ Jublia by expanding the definition of what the antifungal medication treated, the drugmaker told the Federal Circuit in a bid to revive the patent. Read full article »

Fed. Circ. Urged Not To Review Venue In $20M Cialis IP Row

A German pharmaceutical company has urged the Federal Circuit not to rehear a panel decision that upheld a $20 million Eastern District of Texas jury verdict that Eli Lilly and Co.’s Cialis drug infringed its patent, saying that Lilly lost its chance to make validity and venue challenges by not raising them earlier. Read full article »

Valeant Copycat Drug Row Can Stay In Calif., Judge Rules

A unit of Valeant Pharmaceuticals can keep its false drug marketing claims against a subsidiary of rival Virtus Pharmaceuticals in California federal court, a judge has ruled, finding the dispute didn’t have to go through the U.S. Food and Drug Administration first. Read full article »

Direct Buyers Fight GSK, Teva's Bid To Stay Lamictal Suit

Drug wholesalers urged a New Jersey federal court Monday to nix a bid from GlaxoSmithKline PLC and Teva Pharmaceutical Industries Ltd. to pause an antitrust suit over the availability of generic alternatives to epilepsy drug Lamictal while the companies seek Third Circuit review of the direct buyers’ class certification. Read full article »

Archer Daniels Escapes Bulk Of Deadly Horse Feed Suit

Archer Daniels Midland Co. on Tuesday dodged much of a proposed class action brought by two horse owners who alleged contaminated feed products harmed their animals, when an Illinois federal judge said most of the owners' claims don't have a legal foundation. Read full article »

DEALS

Deals Rumor Mill: Fawaz Alhokair, Saudi Aramco, Colfax

Fawaz Alhokair Group has reportedly tapped Morgan Stanley and Moelis related to reignited plans to float its Arabian Centres malls unit, Saudi Aramco could invest billions in natural gas in the United States, and Colfax Corp. has tapped Goldman Sachs to help it sell its Howden unit. Read full article »

EXPERT ANALYSIS

International Law In 2018: Key Developments

2018 was full of important developments in international law, including a new North American trade treaty, significant litigation at the International Court of Justice, and rulings by various bodies related to environmental, human rights and criminal law, say Viren Mascarenhas and Douglass Cassel of King & Spalding LLP. Read full article »

Opinion

Courts Are Getting It Right On Litigation Funding Discovery

Earlier this month, a California federal court denied discovery into the identification of third-party funders with a financial interest in the outcome of an underlying patent infringement action. This decision in MLC v. Micron follows a long line of well-reasoned precedent across U.S. federal courts, say Matthew Harrison and Sarah Jacobson of Bentham IMF. Read full article »

LEGAL INDUSTRY

Firms' Crawl To Gender Diversity Shows Long Road Ahead

U.S. law firms are on track to achieve gender parity in partner promotions by 2032, and gender parity within the partner ranks at a time far beyond that, a reality some say necessitates drastic change if firms hope to alter the current trajectory. Read full article »

Judiciary Says It Will Stay Funded Through January

The administrative agency of the federal court system said Tuesday that federal courts will have enough funding to continue operating until Jan. 31 despite the government shutdown, the third time the courts have extended the estimated date when they will have to start cutting staff. Read full article »

Skadden Deal Unfair, Russian Co. Says In Troll Farm Case

A Russian company criminally charged with thwarting enforcement of the Foreign Agents Registration Act asked a judge on Tuesday to make prosecutors explain why Skadden Arps Slate Meagher & Flom LLP "was permitted to purchase a declination" in its own FARA case. Read full article »

Legal Field Has 'Enthusiasm Gap' For Gender Equity Initiatives

While there is general support in the legal field for policies geared toward reaching gender equity in the industry, a survey released on Tuesday reveals an “enthusiasm gap” by which women are more likely to champion these efforts than their male colleagues. Read full article »

Girardi Keese, Thomas Girardi Owe $15M, Legal Lender Says

Law Finance Group LLC has hit the law firm Girardi Keese and trial attorney Thomas V. Girardi with a breach of contract suit in California state court claiming they have failed to make repayments on a debt of more than $15 million. Read full article »

Ex-Weil Partner Sues MetLife For Disability Benefits

A former Weil Gotshal & Manges LLP bankruptcy partner has hit Metropolitan Life Insurance Co. with a lawsuit in New York federal court accusing the insurance carrier of wrongly denying him long-term disability benefits even though he suffers from a series of psychiatric problems. Read full article »

Education Department GC Named Fla. Supreme Court Justice

Florida Gov. Ron DeSantis filled the final vacant seat on the Florida Supreme Court Tuesday with the appointment of Carlos Genaro Muñiz, who is serving as general counsel at the U.S. Department of Education and will be the first Nicaraguan-American on the state’s highest court. Read full article »

Interview

15 Minutes With Planet Fitness' General Counsel

To Planet Fitness World Headquarters General Counsel Justin Vartanian, the biggest challenge for his industry is to motivate others to incorporate fitness into their lives. Here, he explains the benefits lawyers can gain from healthy lifestyles as the legal industry strives to reduce stigmas that surround mental health, and offers advice on how to stick to wellness-related resolutions amid demanding workloads. Read full article »

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Activision Blizzard, Inc

Albertsons Companies LLC

American Bar Association

American Federation of Labor and Congress of Industrial Organizations

Archer Daniels Midland Co.

Argentum Pharmaceuticals LLC

CSL Behring LLC

CVS Caremark Corporation

Caterpillar Inc.

Chevron Corp.

Colfax Corporation

DePuy Synthes Cos.

Eli Lilly and Co.

FTI Consulting Inc.

Facebook

Fujifilm

GlaxoSmithKline

Goldman Sachs Group Inc.

Google Inc.

Helsinn Healthcare SA

Hologic, Inc.

Howden Insurance Brokers Ltd.

IMF Bentham Ltd.

Imerys SA

Instagram Inc.

Johns Manville Corp.

Johnson & Johnson

Kmart Corp.

Law Finance Group Inc.

MannKind Corporation

MetLife Inc.

Micron Technology Inc.

Morgan Stanley

NCB Capital Co.

New York University

Northeastern University

Oxfam America Inc.

Planet Fitness Inc.

Rochester Drug Cooperative Inc.

S.A.C. Capital Advisors LP

SUPERVALU INC.

Saudi Arabian Oil Co.

Teva Pharmaceutical Industries Limited

Twitter Inc.

United Nations Commission on International Trade Law

Valeant Pharmaceuticals International

Walgreen Co.

Walgreens Boots Alliance Inc.

Washington Legal Foundation

Zillow Inc.

LAW FIRMS

Ashby & Geddes

Bailey & Glasser

Bartlit Beck

Berger Montague

Brinks Gilson & Lione

Cohn Lifland

Debevoise & Plimpton

Dentons

Dilworth & Barrese

Eisner APC

Faruqi & Faruqi

Finnegan

Garwin Gerstein

Girardi & Keese

Goodwin

GrayRobinson

Heim Payne

Hogan Lovells

Husch Blackwell

Kazan McClain

King & Spalding

Kirkland & Ellis

Loeb & Loeb

Lowenstein & Weatherwax

Lowenstein Sandler

McAndrews Held

McGuireWoods

Nelson Mullins

Orrick Herrington

Paul Hastings

Pepper Hamilton

Rakoczy Molino

Reed Smith

Ropes & Gray

Saul Ewing

Skadden

Smith Segura

Stein Mitchell

Sterne Kessler

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