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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- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 2024
- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 2024
- 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