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WLF Cautions FDA Regarding Park Doctrine
November 1, 2010By Peter M. Jaensch –
Over the last seven months, officials at FDA, including the FDA Commissioner, Margaret Hamburg, MD, and the Deputy Chief Counsel for Litigation, Eric Blumberg, have been promising to resume use of the individual criminal liability doctrine known as the Park Doctrine (also known as the Responsible Corporate Officer Doctrine). If this occurs, it would increase the stakes for alleged violations of the Federal Food, Drug, and Cosmetic Act. Because FDA appears to believe that fines, penalties, and other money payments have not deterred certain conduct, it now seems to believe that individual criminal liability for corporate officers will be a better deterrent. We have earlier written several pieces on this subject (here, here, and here among others).
On October 26, 2010, the Washington Legal Foundation (“WLF”) sent a letter to FDA. WLF calls on FDA to abandon its plans to seek criminal sanctions under Park for company executives for promotional activities in instances where the executives never participated in, encouraged, or had knowledge of the alleged violations.
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- FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting November 28, 2023
- Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act November 28, 2023
- FDA Proposes to Ban Brominated Vegetable Oil in Food November 23, 2023
- Going to 11: New Subsections at CDER’s Office of Pharmaceutical Quality Are Important Piece of FDA’s Inspection and Enforcement Strategy November 20, 2023
- HP&M Recognized by Best Law Firms® as National Tier 1 – FDA Law and Regional Washington, DC Tier 1 – FDA Law (2024 Edition) November 15, 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