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"U.S. v. Novartis: Reaffirming the Importance of Updating and Adhering to Corporate Policies"

A recent decision in a false claims act case, United States ex rel. Bilotta v. Novartis Pharmaceuticals Corporation (Novartis), underscores the importance of policing employee adherence to corporate policies and industry...more

11/18/2014 - Anti-Kickback Statute Chief Compliance Officers False Claims Act Health Care Providers Novartis Pharmaceutical Manufacturers Popular Risk Management

"FDA Guidance Limits Flexibility in Social Media Promotional Communications"

Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via social media and other interactive...more

7/22/2014

"Is the DOJ FCPA Enforcement Hegemony Dead?"

For nearly 15 years, the United States has had the worldwide corruption enforcement stage to itself, reaping billions of dollars in fines and settlement payments from companies that have acknowledged engaging in bribery in...more

6/27/2014 - DOJ Enforcement FCPA International Banks UK UK Bribery Act World Bank

"HHS OIG Issues New Guidance on Patient Assistance Programs"

On May 21, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a special advisory bulletin addressing independent charity patient assistance programs (PAPs) for federal health care...more

5/27/2014 - Healthcare HHS OIG Patient Assistance Programs Prescription Drugs

"Health Care and Life Sciences: Affordable Care Act Rollout to Impact M&A and Enforcement Activity"

Health care and life sciences companies face a variety of issues in 2014, including further difficulties with the Affordable Care Act (ACA) rollout because of legal and logistical challenges, the potential dampening of...more

1/28/2014 - Affordable Care Act CMS Enforcement Actions Healthcare Healthcare Reform Life Sciences Medicare Preexisting Conditions

"Health Care Enforcement Update: What Is in Store for the Next Five Years"

While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more

6/26/2013 - Affordable Care Act Criminal Prosecution DOJ Enforcement Actions False Claims Act FBI FDA Healthcare HHS Medical Devices OIG Pharmaceutical

OIG Releases Updated Provider Self-Disclosure Protocol

On April 17, 2013, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services released an updated Provider Self-Disclosure Protocol (SDP). As self-described, OIG updated the SDP to...more

5/21/2013 - Disclosure Requirements Eligibility OIG Self-Disclosure Requirements Transparency

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

5/15/2013 - Civil Monetary Penalty Criminal Sanctions False Claims Act FDA FDCA Penalties Settlement

"Second Circuit Vacates Conviction Based on Off-Label Promotion, Deals Blow to Government Theory in Drug Marketing Cases"

In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a...more

12/5/2012 - Commercial Speech Criminal Prosecution FDCA Free Speech Healthcare Off-Label Use Pharmaceutical

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