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Prescription Drugs Dept. of Justice

AGG Food and Drug Newsletter - August 2017

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

Department of Justice Pilot Program Will Focus on Opioid Fraud and Abuse

by Arnall Golden Gregory LLP on

On August 2, 2017, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit and a new Department of Justice (DOJ) data analytics program to combat opioid-related fraud and abuse. The...more

Antidotes for America’s Addiction Crisis

Opioid addiction and abuse has exploded into a national epidemic. Every three weeks, America faces a death toll equivalent to the September 11th attacks due to drug overdoses, 75 percent of which are from opioid use. ...more

Recent Department of Justice Crackdown on Fraud and Abuse

As reported by the New York Times in an article dated July 13, 2017, in an effort to crack down on fraud and abuse, and with a particular focus on opioids, the Department of Justice (“DOJ”) is charging 412 individuals for...more

Healthcare Law Update: June 2017

by Holland & Knight LLP on

Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...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

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

Teva FCPA Enforcement Action-Part I

by Thomas Fox on

Just when you were thinking things could not get any bigger after the Odebrecht/Braskem Foreign Corrupt Practices Act (FCPA) enforcement action, the Department of Justice (DOJ) and Securities and Exchange Commission (SEC)...more

A Cautionary Tale: DOJ Intervenes in Another Web Accessibility Lawsuit

by Seyfarth Shaw LLP on

Seyfarth Synopsis: Fighting a web accessibility lawsuit could invite DOJ’s intervention, as did a Florida retailer’s recent Motion for Judgment on the Pleadings. Fighting a website accessibility lawsuit is very tempting...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Your Daily Dose of Financial News

by Robins Kaplan LLP on

Some good news for the UK after a brutal few days for the pound? It appears that the pound’s precipitous fall has acted as a sort of “giant shock absorber” against Brexit—a release valve of sorts that has meant decreased...more

When It Absolutely, Positively Has to Be Indicted Overnight: How to Prevent Future Debacles Like the FedEx Prosecution

by Pepper Hamilton LLP on

Against the backdrop of years of unprecedented monetary penalties imposed through DOJ civil settlements and deferred prosecution agreements with financial institutions embroiled in the 2008 financial meltdown, the DOJ came...more

Drug Companies and Charitable Patient Foundations

by Michael Volkov on

Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....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

Pharmaceutical Company Reaches Preliminary Agreement in Principle to Resolve DOJ and SEC Investigations

by Arnall Golden Gregory LLP on

So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...more

Failure to Disclose Best Pricing: Pharmaceutical Companies Settle FCA Claims for $784 Million

by Dorsey & Whitney LLP on

The Department of Justice announced late last month that pharmaceutical manufacturers Wyeth and Pfizer would pay $784 million to resolve a False Claims Act investigation and qui tam lawsuit arising from Wyeth’s failure to...more

President Obama Signs Zika Priority Review, Controlled Substances Laws

by Reed Smith on

President Obama has signed into law S. 2512, which adds Zika virus to the Food and Drug Administration priority review voucher program to encourage the development of treatments for neglected tropical diseases. In addition,...more

A&B Healthcare Week in Review

by Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

Pharmaceutical Diversion – Risks and Steps to Address a Major DEA Focus

by K&L Gates LLP on

The opioid crisis, an ever-increasing focus of the Obama administration and 2016 Presidential Primary field, has highlighted the efforts of the Drug Enforcement Administration (DEA) and the Department of Justice (DOJ) to...more

Drug and Medical Device Corruption Risks in China

by Michael Volkov on

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

Health Care Update - November 2015

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Health Care Physicians in the Crosshairs: Criminal Prosecution

by Pullman & Comley, LLC on

Recent changes to our health care system have been at the forefront of the American news cycle for several years. But certain aspects have not received adequate attention. One example is the scrutiny federal and state...more

Health Law Pulse - October 2015

by Robinson & Cole LLP on

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

Southern District of New York Finds Amarin Pharma, Inc.’s Off-Label Promotion Is Protected Speech; Company Cannot Be Prosecuted...

by Saul Ewing LLP on

Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more

Kmart Settlement Shows Breadth of Healthcare Practices Government Says Violate False Claims Act

by Saul Ewing LLP on

A recent settlement by retailer Kmart Corp. illustrates the breadth of practices in the healthcare space that the government considers to be illegal kickbacks that violate the False Claims Act (FCA). The U.S. Department of...more

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