News & Analysis as of

Criminal Prosecution Pharmaceutical Industry

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

by Arnall Golden Gregory LLP on

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more

Criminal Overreach

by Reed Smith on

Come visit us in our office whilst we are poring over a brief and, with minimal provocation, we will put aside the task at hand and start gabbing about our days as a prosecutor. Come sit next to us while we are pouring a...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

U.S. Supreme Court’s Decision Not to Take Certiorari in United States v. DeCoster is a Reminder to the Food and Drug Industries to...

by Liskow & Lewis on

Earlier this year there was hope in the food and drug industries that the Supreme Court would revisit and possibly revise the Responsible Corporate Officer Doctrine, also known as the Park Doctrine, by granting certiorari to...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

Reimbursement Manager Pleads Guilty for Prior Authorization Process Issues

by Bass, Berry & Sims PLC on

On Monday, June 19, 2017, Elizabeth Gurrieri became the second former employee of Insys Therapeutics (Insys) to plead guilty to federal anti-kickback charges related to the drug Subsys, an expensive fentanyl-based painkiller....more

The Responsible Corporate Officer Doctrine in the Wake of DeCoster

Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more

The Government Seeks to Intervene in its Third Generic Drug Price-fixing Lawsuit

Since we last reported on the state and federal government’s generic drug pricing investigations and litigations (click here to read more), the U.S. Department of Justice (“DOJ”) has obtained its first guilty pleas. On...more

Health Care Fraud and Abuse in the Middle District of Florida in 2016 - a Year in Review

by Carlton Fields on

The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more

Dentons' pick of global regulatory trends to watch in 2017 - Competition/antitrust law

by Dentons on

Focus on the US - In the wake of the 2016 elections, we now await the decision as to who will be the "antitrust guard" at the top of the US Department of Justice (DOJ) and the Federal Trade Commission (FTC). At the...more

French Legal and Regulatory Update – December 2016

by Hogan Lovells on

The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e-newsletter, which offers a legal and regulatory update covering France and Europe for December 2016. Please see full...more

DOJ and SEC Close Out 2016 with a $520 Million FCPA Settlement

by Arnall Golden Gregory LLP on

The Securities and Exchange Commission (SEC) and Department of Justice (DOJ) wrapped up 2016 on December 22 with a near record-breaking Foreign Corrupt Practices Act (FCPA) settlement involving Teva Pharmaceuticals and its...more

Alert: Antitrust 2017: Trends and Developments to Watch

by Cooley LLP on

1. Transition to a Trump Administration is top of the agenda - President-elect Donald Trump's DOJ and FTC transition team appointments and public short list of candidates to run the agencies indicate that antitrust...more

Teva FCPA Enforcement Action – Part II

by Thomas Fox on

Yesterday, I began an exploration of the Foreign Corrupt Practices Act (FCPA) enforcement action involving Teva Pharmaceuticals Industries Ltd. (Teva). It was brought jointly by the Department of Justice (DOJ) and Securities...more

Two Executives Charged in Valeant Pharmaceuticals Criminal Investigation

by Michael Volkov on

Two executives were charged last week with criminal violations in the Southern District of New York relating to Valeant Pharmaceuticals activities. These charges are the first of more to come in an ongoing investigation...more

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

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 companies and included...more

New Anti-Corruption Laws on the Health Care Sector in Germany: Is There Any Impact on the Food Industry?

by King & Spalding on

Germany recently adopted new anti-corruption laws that now criminalize “taking bribes in the health care sector” and “giving bribes in the health care sector.” These new laws have implications for certain segments of the food...more

Leading a Briber On Isn't the Same as Accepting a Bribe: How Gov. McDonnell Beat His Corruption Rap

by Sands Anderson PC on

The Supreme Court has reversed Gov. Bob McDonnell's conviction for bribery under the Hobbs Act. In ruling his conviction must be set aside, the High Court conceded the case was "distasteful," but unanimously concluded that...more

Jury Acquits Former Pharma Exec in One of the First Post-Yates Memo Health Care Fraud Prosecutions

Like many before it, this year has been one to watch in government health care fraud enforcement efforts. In September 2015, the Department of Justice (DOJ) released the “Yates Memo,” which reaffirmed the government’s...more

For congressional overseers, red flags fly over issues at FDA

Congressional overseers of the federal agency that regulates drugs and medical devices have gotten red-flag warnings about problems at the Food and Drug Administration, including: two separate calls for improvements from...more

DOJ Folds Criminal Case Against Federal Express

by Michael Volkov on

In another set back last week, after a contentious criminal prosecution, the government dismissed its criminal charges against Federal Express. DOJ indicted Federal Express for drug trafficking relating to shipping of illegal...more

DOJ Suffers Criminal Trial Setbacks: Warner Chillcott President Acquitted

by Michael Volkov on

Last week was a tough week for the Justice Department’s criminal prosecutors. Before everyone gets out their Yates Memorandum trending claims, it is important to recognize that DOJ’s loss in several high profile cases does...more

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

by Foley Hoag LLP on

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

Competition/antitrust law

by Dentons on

Focus on the US - Cartel enforcement activity and stiffer criminal penalties against price fixing - The Department of Justice (DOJ) continues to investigate and seek criminal charges against worldwide cartels. This...more

Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

by Mintz Levin on

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann...more

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