cGMP Enforcement and Compliance in the Wake of <i>Rostholder</i>

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cGMP Enforcement and Compliance in the Wake of Rostholder

July 27, 2015

BY ERIC SUSSMAN, TERRA REYNOLDS & CHRISTOPHER ALLEN

In recent years, the Department of Justice (“DOJ”) has increasingly pursued pharmaceutical companies for alleged noncompliance with current good manufacturing practices (“cGMP”), and companies have faced criminal and civil penalties in the hundreds of millions of dollars for such violations. While the Fourth Circuit's recent decision in Rostholder casts serious doubts on the government's ability to use cGMP violations as a basis for liability under the False Claims Act, the DOJ’s continued interest in cGMP violations poses risks for the in-house legal and compliance departments of pharmaceutical companies.

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Navigating California’s Wage-and-Hour Laws Calls for Planning, Precision

Delaware’s Court of Chancery Upholds Forum Selection Bylaw Adopted on Day of Merger Announcement and Calling for Exclusive Forum Outside Delaware

The US States Inching Ever Closer to Legalising I-Gaming

ACO Shared Savings Program Fraud and Abuse Waivers Extended by CMS and OIG

Orange County Insider Trading Case Hastens SEC Retreat From Federal Court

SSM and the Quiet Revolution: Italy to Reform Banking and Finance Legislation Under EU Provisions

The Video Privacy Protection Act: Is It the New TCPA (aka Class Action Bonanza)? A Summary of Recent Developments and Tips for Avoiding Successful Suit

Deposing Nonparties in States Other Than Where Your Case is Pending

What are the major trends emerging for Asian cross-border investment into the U.S.?

The Law of Joint Ownership of Patents: The Right to Impede an Infringement Suit

Here We Go Again—The U.S. Government Brings Home Another FCPA Case Against a Life Sciences Company

Interagency Guidance on Leveraged Lending (March 2013)—A Summary of the 2014 Interagency Shared National Credit Review and Answers to the Most Frequently Asked Questions

SEC Increases Enforcement Activity in 2014

Administrative Review Board Makes Proof of Causation for Complainants in Sarbanes-Oxley Retaliation Cases Substantially Easier

The Changing Face of Italian Insurance Companies

District of Delaware Finds Specific Jurisdiction Exists Over an ANDA Filer in the Context of a Hatch-Waxman Case

California Court of Appeal Affirms: Early Discovery Will Not Be Permitted to Aid Derivative Plaintiff in Stating a Claim

The Single Supervisory Mechanism: A Further Step Towards the Banking Union

"QM Equals QRM" … CFPB Paves the Way for Key Exemption to Risk Retention Rule

European State Aid: A Trap for the Unwary Tax Director

Understanding CFPB Supervision and Enforcement—Important Considerations in Working with the Federal Financial Consumer Watchdog

IPOs in the JOBS Act Era 2014

France Levies Surcharge on Dividends

U.S. Government Revives "New Foreign Direct Investment" Reporting Requirement: Questions and Answers on Completing the BE-13 Survey

Attempting to Fix the "Broken Windows": Recent SEC Enforcement Action Targets Routine Disclosure Obligations of Public Corporations and Their Insiders

Transfer Tax Applies on Transfer of Controlling Interest in Legal Entity Holding California Real Property

More Than Mandatory Paid Sick Leave: 21 New California Laws Will Affect Employers With Operations in the State

Report of Counsel on Recent Legal Developments -- Third Quarter 2014

Italy Spices-up its Recipe for Growth with New Measures Aimed at Reinvigorating Appetite for Equity Investments

SEC Sends a $30 Million-Plus Warning to Companies: Beware of the Foreign Whistleblower

Trade Secrets Protection Continues to be a High Priority for Lawmakers: House Judiciary Committee Approves Bill Creating a Federal Civil Remedy for the Misappropriation of Trade Secrets

OFCCP Issues Proposed Rules Prohibiting Discrimination Based Upon Employee Inquiries and Disclosures Regarding Compensation

Real Estate Investment in France: Amendment of the France ‒ Luxembourg Tax Treaty

New EU Antitrust Commissioner, Margrethe Vestager, to Take Office in November 2014, Pending Approval

Italian Data Privacy Law: The Recent Decision on Google

High Stakes in Ukraine: U.S. and EU Ratchet Up Sanctions Against Russia as Fragile Peace Process Gets Underway

FERC Proposes Revisions to its Market-Based Rate Procedures

The SEC Guidance on Cybersecurity Measures for Public Companies

The Antitrust Review of the Americas 2015 - United States: Mergers

The Ninth Circuit Tightens the Screws on Plaintiffs’ Burden to Allege “Loss Causation” when a Corporation Announces an Internal Investigation

Legislative Reform of China’s Healthcare Sector Targets Corruption: Implications for Multinational Companies

IRS Releases New Guidance Regarding Taxpayer Eligibility for Renewable Energy Tax Credits Under Code Sections 45 and 48

SEC Adopts Money Market Fund Reforms

Not So Fast! Sixth Circuit Rescinds Award of Tax Refund to Bankruptcy Estate

Promoting a Culture of BSA/AML Compliance – FinCEN Ups the Ante

Confronting Employment Issues in China M&A Deals

Prosecution Bar in Protective Order Does Not Bar Outside Litigation Counsel from Participating in an Inter Partes Review Proceeding, SDNY Rules

You Win Some and You Lose Some, but Rarely at the Same Time – Iskanian and the California Supreme Court’s Conflicting Treatment of Group-Wide Lawsuits

Federal Contractor Requirements Continue to Expand – Department of Labor Proposes New Pay Data Collection Tool

Asia Outbound Real Estate Investment: Trends, Opportunities and Strategies (Part II)

The Tenth Circuit Rejects Section 11 Claims for "False" Opinions

FTC v. Cephalon, The Fray Begins

FDA Issues Draft Guidance on Reference Product Exclusivity for Biologics

New “Fair Pay and Safe Workplaces” Executive Order Places Unprecedented Demands on Federal Contractors

New Restrictions Curtail Use of U.S. Equipment or Technology for Oil & Gas Exploration and Production in Russia

Seven Environmental “Do’s” and “Don’ts” for Private Equity Investors

Washington Perspectives

"Pay Averaging" Post-Armenta – Revisiting the Prohibition Against "Averaging" Commissions and Piece Rates

New Coordinated U.S. and EU Sanctions Target Russian Banks, Oil Industry

For More Information:

Jay Darden

Email

+1 202 551 1961
Gary F Giampetruzzi

Email

+1 212 318 6417

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