Account

Sign in to access your account and subscription

The Changing Face of FDA Consent Decrees

Historically, when a health care company had a compliance failure, counsel could help it remain in business by negotiating with the relevant agency. If the problem involved sales, marketing or pricing, the company could seek a Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) at Health and Human Services (HHS). If the problems related to manufacturing, counsel could obtain a consent decree of permanent injunction ('consent decree') with the Food and Drug Administration (FDA) under the Food Drug and Cosmetic Act (FDCA). Consent decrees and CIAs each had their particular burdens and benefits, which health care practitioners had learned to navigate. Now this tidy distinction has become blurred as the FDA has borrowed features from HHS's CIAs.

17 minute readFebruary 27, 2007 at 08:36 AM
By
Joseph Savage
Adam Ziegler
The Changing Face of FDA Consent Decrees

Historically, when a health care company had a compliance failure, counsel could help it remain in business by negotiating with the relevant agency.

This premium content is locked for Business Crimes Bulletin subscribers only

ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN Business Crimes Bulletin

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

Already have an account? Sign In Now

For enterprise-wide or corporate access, please contact Customer Service at [email protected] or call 1-877-256-2473.

NOT FOR REPRINT

© 2026 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.

Continue Reading

The combination of increasing operating costs and uncertain government reimbursement funding continues to place health care providers under financial pressure, and in many cases, financial distress. Given the importance of Medicare/Medicaid funding of claims under provider agreements with the federal government, how courts interpret and apply the interplay between the Bankruptcy Code and Medicare Program Act determines the disposition of hundreds of millions of dollars of claims for reimbursement that support the health care system.

April 30, 2026

As AI becomes embedded in everyday business and legal operations, organizations are confronting a new expectation: simply disclosing AI use is no longer enough. A critical shift is taking place in the legal industry: transparency is no longer just about disclosure; it’s about comprehension.

April 30, 2026