- Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter Requirement June 8, 2023
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The Dangers of Do-It-Yourself Enforcement
February 2, 2011In his recent article appearing in FDLI Update, Hyman, Phelps & McNamara, P.C. Associate Peter M. Jaensch discusses the increasing use of the False Claims Act ("FCA") to privately prosecute what are actually violations of the FDC Act, and examines the allegations underlying the recent GlaxoSmithKline ("GSK") settlement, in which GSK agreed to pay $750 million to resolve claims based on violations of current good manufacturing practices ("cGMP"). He proposes that the GSK case represents a clear case of private enforcement of the FDC Act, and argues that the Government’s willingness to press the FCA suit on the basis of what were plainly cGMP violations was shortsighted and increases the likelihood of conflicting precedents.
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- Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter Requirement June 8, 2023
- An Offer You Can’t Refuse: Merck Attacks Medicare Negotiation Program as an Unconstitutional Taking June 7, 2023
- AMCP Format for Formulary Submissions Revision – Comment Period Now Open! June 5, 2023
- CCP Improvements Allow Industry to Track Pre-submissions June 5, 2023
- CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program June 2, 2023
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized