- Internal Mock DEA-Style and Mirror Inspections and Audits: Trust But Verify September 9, 2025
- Commissioner Makary and Center Directors Tidmarsh and Prasad Announce 2 New Programs for Ultra-Rare Disease Therapies: RDEP and Bespoke September 8, 2025
- Radical Transparency, Act II: FDA Releases 89 Previously Unpublished Complete Response Letters September 5, 2025
- Cannabis Redux: Marijuana Rescheduling Act Reintroduced in the U.S. House September 3, 2025
- FDA Lends a Single Arm: Papzimeos Approval Highlights FDA’s Willingness to Rely on Single-Arm Trials for Rare Diseases September 2, 2025
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Off-label Promotion Qui Tam Suits – a YouTube Video by HP&M’s John R. Fleder
October 24, 2008Hyman, Phelps & McNamara, P.C.’s John R. Fleder has now appeared in a Washington Legal Foundation “Legally Brief” YouTube video. In the 6-minute video Mr. Fleder notes the recent increase in federal False Claims Act cases initiated by private whistleblowers based on alleged “off-label” use promotional activities involving pharmaceutical companies, and explains why recent court rulings have dismissed such cases, and cast doubt on the viability of any off-label use “qui tam” action.
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- Best Lawyers in America® – 2025
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- Internal Mock DEA-Style and Mirror Inspections and Audits: Trust But Verify September 9, 2025
- Commissioner Makary and Center Directors Tidmarsh and Prasad Announce 2 New Programs for Ultra-Rare Disease Therapies: RDEP and Bespoke September 8, 2025
- Radical Transparency, Act II: FDA Releases 89 Previously Unpublished Complete Response Letters September 5, 2025
- Cannabis Redux: Marijuana Rescheduling Act Reintroduced in the U.S. House September 3, 2025
- FDA Lends a Single Arm: Papzimeos Approval Highlights FDA’s Willingness to Rely on Single-Arm Trials for Rare Diseases September 2, 2025
- 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