- DEA To Host Supply Chain Conference March 31, 2023
- 2023 IS the Year for OTC Naloxone! March 30, 2023
- What is Special about September 24, 2023 for the UDI System? March 28, 2023
- The “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps” – Availability of HPM’s Presentation Deck and Recording of the Presentation March 28, 2023
- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 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
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.
Search FDA Law Blog
Subscribe
Latest Tweets
Tweets by @fdalawblogAwards & Honors
- The Best
Lawyers in America
US News & World Report - Ranked in Chambers USA 2018
- DEA To Host Supply Chain Conference March 31, 2023
- 2023 IS the Year for OTC Naloxone! March 30, 2023
- What is Special about September 24, 2023 for the UDI System? March 28, 2023
- The “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps” – Availability of HPM’s Presentation Deck and Recording of the Presentation March 28, 2023
- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 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