"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)...
View Article"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Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via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...
View Article"Insights Conversations: Life Sciences"
A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden...
View Article"HHS OIG Issues New Compliance Oversight Guidance for Boards of Directors"
On April 20, 2015, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published its “Practical Guidance for Health Care Governing Boards on Compliance...
View Article"Supreme Court Decision in FCA Case Both a Win, Setback for Health Care...
On May 26, 2015, the U.S. Supreme Court issued a rare unanimous decision in a False Claims Act (FCA) case that cuts both ways for the health care industry. In an opinion authored by Justice Samuel...
View Article"King v. Burwell: Round 2 for the Affordable Care Act"
On June 25, 2015, the U.S. Supreme Court announced its long-awaited decision in King v. Burwell. The Court concluded that statutory language in the Affordable Care Act (ACA) authorizing tax credits for...
View Article"The Future of Government Regulation, Enforcement of Off-Label Promotion"
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful,...
View Article"Key Takeaways: Fifth Annual Pharmaceutical and Medical Device Seminar"
On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the...
View Article"Financial Relationships Likely to Be a Focus in Life Sciences Enforcement...
For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and...
View ArticleRecent Corporate Integrity Agreements Highlight HHS OIG’s Compliance Program...
Corporate Integrity Agreements (CIAs) are among the most important tools in the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) toolbox for promoting compliance in the...
View Article"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal...
In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a...
View Article"Supreme Court Permits Use of Statistical 'Representational Evidence':...
On March 22, 2016, the U.S. Supreme Court issued a decision in the Fair Labor Standards Act (FLSA) class action Tyson Foods, Inc. v. Bouaphakeo. In an opinion authored by Justice Anthony Kennedy, the...
View Article"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"
The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of...
View Article"In Escobar, Supreme Court Upholds False Claims Act’s Implied Certification...
On June 16, 2016, the U.S. Supreme Court in Universal Health Services v. United States ex rel. Escobar unanimously upheld the implied certification theory of False Claims Act (FCA) liability. The Court...
View ArticleKey Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and...
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such...
View Article"Escobar and the Implied Certification Theory: Initial Cases Raise the Bar on...
On June 16, 2016, the U.S. Supreme Court in Universal Health Services, Inc. v. United States ex rel. Escobar1 (Escobar) unanimously upheld the implied certification theory of False Claims Act (FCA)...
View ArticleSupreme Court Holds That Violations of the False Claims Act’s Seal...
On December 6, 2016, the Supreme Court of the United States ruled unanimously in State Farm Fire and Casualty Co. v. United States ex rel. Rigsby that violations of the False Claims Act’s (FCA) seal...
View ArticleThe 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the...
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is...
View Article"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label...
On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such...
View Article"Republicans Chart New Course for US Health Care System"
While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health...
View Article"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use...
2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA...
View ArticleAegerion Settles Criminal and Civil Probe of Promotional Practices, REMS and...
On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a...
View ArticleA Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical...
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ)...
View ArticleAs Congress Struggles With ACA Repeal, Trump Administration Moves Forward...
The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid...
View ArticleHealth Care Investigation Trends: Corporate Integrity Agreements No Longer a...
2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies...
View ArticleEnforcement and Litigation Strategies: Skadden’s Eighth Annual...
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies...
View ArticleA Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and...
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies...
View ArticleFailure to Report Adverse Events Results in Criminal Misbranding Settlement...
On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of...
View ArticleHHS OIG Closes 2018 With New Fraud Risk Indicator for Corporate Integrity...
While the number of new corporate integrity agreements (CIAs) declined since last year, and was below the trailing five-year average, 2018 was an important year on the policy front for the Office of...
View ArticleSkadden's 2019 Insights: Trump Policy Actions Could Reshape Health Care and...
In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many...
View ArticleThe 10 Most Important Changes in the New and Improved AdvaMed Code of Ethics
At the close of 2018, the Advanced Medical Technology Association (AdvaMed) released an updated version of its Code of Ethics governing medical technology manufacturers in their interactions with...
View ArticleSweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans
The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and...
View ArticleA Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and...
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout...
View ArticleHHS-OIG Year in Review: Pharma and Medical Device CIAs Increase, Include...
Corporate integrity agreements (CIAs) continued to be an important tool for the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) in 2019. Notably, pharmaceutical and...
View ArticleDrug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life...
View ArticleSkadden's 2020 Insights
Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging...
View ArticleCoronavirus/COVID-19 Update
As health organizations and governments around the world work to contain the coronavirus (COVID-19), businesses should be mindful of the various ways the virus may impact their operations and...
View ArticleEnforcement Spotlight: US Prosecutors Continue To Target Medical Technology...
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice...
View ArticleFDA Issues Guidance on Prescription Drug Sample Distribution During COVID-19
On June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID-19 public health...
View ArticleFDA Announces That Domestic Inspections Will Resume
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility...
View ArticleNovartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry...
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care...
View ArticleHHS-OIG Signals Increasing Skepticism of Speaker Programs, Identifies...
On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated...
View ArticleHHS-OIG Year in Review: Despite Challenges Posed by the Pandemic, 2020 Saw an...
Despite the challenges posed by the COVID-19 public health emergency in 2020, the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) entered into the highest number of...
View ArticleDOJ Introduces Novel Theories of Liability and Requires Unprecedented...
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements...
View ArticleDOJ’s Evolving Enforcement Approach to Off-Label Promotion
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements...
View ArticleNavigating Relationships With Practice Support and Other Tech Vendors
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements...
View ArticleDOJ and FDA Target Companies That Undermine FDA Oversight
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements...
View ArticleJoint Promotional Programs With Physicians Raise Compliance Risks
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - Recent settlements between the U.S. Department of Justice (DOJ) and a...
View ArticleDOJ Puts Teeth in Sunshine Act Reporting Requirements
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers About the Enforcement in Life Sciences Series Recent settlements between...
View ArticleRecent Enforcement Settlements Highlight Continued Scrutiny of Quality and...
Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims...
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