News & Analysis as of

Public Disclosure Pharmaceutical Industry

Healthcare Fraud and Abuse Review 2016

by Bass, Berry & Sims PLC on

Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more

Fourth Circuit Holds False Claims Act Relators Cannot Use Facts Learned by Their Attorney in a Previous Case to Defeat the FCA’s...

by Ropes & Gray LLP on

Earlier this year, the Fourth Circuit held in United States ex rel. May v. Purdue Pharma L.P., 811 F.3d 636 (2016) that the a complaint that is “based on” relators’ attorney’s work on a prior dismissed FCA action triggers the...more

AGG Food and Drug Newsletter - February 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

A Relator by Any Other Name Not as Sweet: The Fourth Circuit Affirms Dismissal of FCA Suit Based on Facts Learned by Relator’s...

The Fourth Circuit recently held that a relator is prohibited from pursuing a False Claims Act (FCA) claim based on facts learned by relator’s counsel in a previous FCA suit. In United States ex rel. May v. Purdue Pharma...more

A Radical Overhaul? The Third Circuit Analyzes the Federal False Claims Act's Public Disclosure Bar after the Patient Protection...

by Pepper Hamilton LLP on

To dismiss a case based on the public disclosure bar, the defense will have to establish that the allegations of fraud already were exposed in the news media or certain federal sources of information. Pharmaceutical,...more

Generic Pricing Investigations Expand: Par Is Subpoenaed and the OIG Launches Its Own Investigation

Since we last reported on the generic pricing investigations the investigations have expanded. Par Pharmaceutical Companies, Inc. disclosed in its March 13, 2015 Annual Report that it had received a December 5, 2014...more

FDA Revises Approach to Presentation of Risk Information in Brief Summary

by King & Spalding on

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

Ensuring Data Protection In The Implementation Of The EFPIA Disclosure Code: Key Challenges And How Pharmaceutical Companies Are...

by Allen & Overy LLP on

The EFPIA Disclosure Code will, from 2016, require pharmaceutical companies to disclose details of payments and transfers of value made to healthcare professionals and healthcare organisations. The Code aims to promote,...more

Whistleblowers Must Have Independent Knowledge to Actually Blow the Whistle

by Foley & Lardner LLP on

To bring a valid qui tam action and overcome the so-called “public disclosure bar” under the False Claims Act (“FCA”), a whistleblower must have direct knowledge of the alleged fraudulent activity, independent of already...more

Advertising Law - Oct 2014

FTC Mows Down Astroturfing at Yahoo - The Federal Trade Commission has closed an investigation into “astroturfing” by Yahoo employees and declined to take enforcement action because of the limited number of workers...more

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

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