Penalties for corporate compliance failures are changing dramatically with far-reaching, new compliance requirements built into recent integrity agreements that cost companies untold millions for years after a case is resolved.

How can you get a handle on this? Here’s where to start…

To understand how life is changing, for companies operating under corporate integrity agreements, you need to look deep into the recent settlement agreements that drug and device companies are signing. There, you’ll find the requirements spelled out for:

• Expanded compliance attestations that must be signed by multiple layers of management
• Extensive financial auditing and monitoring requirements conducted by company-hired consultants
• Company-wide training and education programs
• Added responsibilities for boards of directors
• Increased quality manufacturing audits
• New personal liability for company managers
• And more…

From compliance expert David Yarin of Navigant Consulting and the editors and reporters of FDAnews, here is protection-oriented reporting on what key government enforcement cases reveal about the trends — and new dangers — involved in hammering out corporate integrity agreements and settlements of false claims.

In addition to authoritative analysis, you’ll have reference for all the most recent relevant agreements and settlement documents — 18 in all — to study in detail.

Buy now to benefit from having one source for the latest compliance information, including:

• A clear overview of Department of Justice and Inspector General settlement and integrity agreements

• Insights into new settlement conditions, such as audit committees with detailed reporting obligations, greater board of directors responsibilities, exclusion from Medicare, mandatory GMP audits and inspections, annual certifications of compliance by key employees, new personal responsibilities for corporate officers and employees, and more

• Important case details from the past year’s most significant prosecutions and settlements

• Expert analysis of what new priorities and trends from recent prosecutions signal for your own activities — from labeling, marketing and wholesale pricing to quality control problems that affect the sale of products to federal customers

• Full text of selected corporate integrity agreements and settlements

Remember, the drug and device compliance problems DOJ and OIG are targeting may be familiar, but the stakes are higher than ever. Use this FDAnews report now to protect against having to enter into a settlement that wreaks havoc on your board, executives, employees and operations.

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