FCA

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John Bell Hood and the Measurement of Conduct Risk

Readers of this blog know I am huge Civil War buff. Growing up in Texas, I only focused on the Southern side as a youngster and while this led to a sometime myopic view of events, in my mid-20s when I did begin to study the...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

Third Circuit affirms dismissal of False Claims Act suit, citing contract ambiguity

Ambiguous contract terms are ordinarily a liability for government contractors, opening the possibility of misunderstandings, expensive disputes, and, potentially, unpaid additional work. However, contract ambiguity recently...more

Defining, Enforcing and Preventing Conduct Risk

An international focus on defining, preventing, and understanding the concept of “conduct risk” has become problematic for financial services organisations in the UK and beyond—in part because the term is not yet clearly...more

10 Popular Reads Covering Latest European Union Developments

Recap of popular updates covering latest developments in the European Union....more

The UK Bribery Act, Three Years On: Can We Relax Yet?

The Bribery Act 2010 has now been in force for three years. Despite the announcements and commentary that it heralded a new and aggressive face toward corporate corruption, there have as yet been no corporate prosecutions...more

Individual Liability: What’s Behind The Headlines?

It’s been open season on financial institutions since the 2008-2009 financial crisis (“Financial Crisis”). State and federal prosecutors and regulators are competing with each other for press coverage of their latest consent...more

Application of the European Market Infrastructure Regulation to Alternative Investment Fund Managers

European investment managers of non-UCITs funds will have to be authorised as an alternative investment fund manager (known as an “AIFM” under AIFMD) under the Alternative Investment Fund Managers Directive (“AIFMD”) from 22...more

Health Headlines: Also in the News - July 2014

New ACO Rules Sent to OMB for Review – On June 26, 2014, a proposed Accountable Care Organization (ACO) rule that would make changes to the Medicare Shared Savings Program in advance of the second round of ACO contracts...more

FCA Brings Greater Clarity and Rigour to UK’s “Soft Commission” Regime

Changes to the use of dealing commission rules, including a ban on “softing” of corporate access services, reflect the FCA’s continuing objective to ensure that investment managers control the costs that they pass on to their...more

Hospitals Urging SCOTUS to Limit False Claims Act Penalties

What do a moving company and a hospital association have in common? The False Claims Act (FCA). The American Hospital Association along with the United States Chamber of Commerce and the Pharmaceutical Research and...more

Copyright Litigation and the Risk of Double Costs

An American photojournalist, Ms. Leuthold, was on the scene in New York City on September 11, 2001. She licensed a number of still photographs to the CBC for use in a documentary about the 9/11 attacks. The photos were...more

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

UK Implementation of AIFMD – Transitional Period Extended

In December 2013, HM Treasury announced that the transitional period allowing existing U.K. alternative investment fund managers (AIFMs) to continue managing their alternative investment funds (AIFs) without receiving...more

FCA Chief announces Project Innovate: Helping Firms Meet the Technological and Regulatory Challenge

The head of the UK's Financial Conduct Authority, Chief Executive Martin Wheatley, used a speech at Bloomberg, London given on 3 June 2014 to promote the FCA's Project Innovate (the drafted text of Martin Wheatley's speech...more

Financial Regulatory Developments Focus - June #3

In this issue: - Compensation - Capital and Prudential Regulation - Bank Structure - Financial Services - Consumer Protection - Enforcement - People - Events...more

Third Circuit Adopts Relaxed Pleading Standard for False Claims Act Cases

The United States Court of Appeals for the Third Circuit recently rejected the strict approach taken by many federal circuit courts to Federal Rule of Civil Procedure 9(b) that requires a qui tam relator bringing a False...more

FCA Fines Retail Investment Management Firm for Failings Relating to Fund Management

In this report we consider the FCA’s decision to fine Invesco Asset Management Ltd and Invesco Fund Managers Ltd (together, Invesco Perpetual) £18,643,000 for failings relating to fund management and for exposing investors to...more

OIG's Proposed Rule to Expand Civil Monetary Penalties

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) on May 12, 2014 published a proposed rule (Proposed Rule) that would implement the OIG’s expanded authority under the Affordable Care...more

Insurance Recovery Law - June 2014

Lab’s “Body Bag” Presentations Triggered Coverage For Defamation Claims: Why it matters - We’ve all sat through some pretty boring PowerPoint presentations. But the lesson from a recent decision: it might be a...more

Joining AIM: A Field Guide For Applicants To AIM, A Market Of The London Stock Exchange

1. What is the process for admission to trading on AIM? Publication of either a prospectus or an admission document. A prospectus is required where a company is offering shares to the public under the Financial...more

2014: A Big Year in Whistleblower Laws

The Securities and Exchange Commission (SEC) began the whistleblower program on July 21, 2010 to incentivize people to come forward with information about financial wrongdoing. Under the program, a whistleblower is entitled...more

Court enforces False Claims Act’s first-to-file rule to bar complaint alleging details of off-label promotion scheme about which...

In Brief - When an alleged scheme to market drugs for unapproved “off-label” uses had already been identified by an earlier complaint, a later complaint providing additional details, but alleging the same “essential...more

Whistleblower’s one-two punch: Confidential informant/employee spurs criminal investigation, then successfully sues individual...

Schuylkill Products case highlights how a whistleblower can put an employer on track to face both criminal and civil proceedings under the False Claims Act....more

FCA Publishes Regulation Round-Up

On May 27, the Financial Conduct Authority (FCA) published its May issue of regulation round-up, a newsletter providing details of the FCA’s recent activity. One issue identified in the regulation round-up is the...more

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