Food and Drug Administration deputy chief for ligitation Eric Blumberg has said executives of companies guilty of promoting off-label uses of their products may be liable for misdemeanor prosecutions, according to a Bloomberg news release.
Under the Food, Drug and Cosmetic Act, a company is required to specify each intended use of a product in its application to the FDA. After the FDA approves the product for its specified uses, any promotion by the manufacturer for other uses renders the product misbranded.
Executive can be prosecuted for violating the Food, Drug and Cosmetic Act, though this strategy has not been widely used. Executives face the possibility of being hit with fines as much as $100,000 and one year in jail. The FDA can also bar the executives from working in the drug industry, according to the report.
Mr. Blumberg did not offer a timetable for the FDA to take disciplinary actions, according to the report.
Read the Bloomberg news report about FDA prosecutions against pharmaceutical company executives.
Read other coverage about pharmaceutical companies and fraud:
- Wright Medical Resolves Investigations Into Alleged Kickback Scheme, Agrees to Pay $7.9M
- Novartis Pays $422M to Settle Allegations of Illegal Drug Promotion, False Claims, Paying Kickbacks
- Pharmaceutical Company AstraZeneca Settles Allegations of Off-Label Marketing and Paying Kickbacks, Pays $520M
Under the Food, Drug and Cosmetic Act, a company is required to specify each intended use of a product in its application to the FDA. After the FDA approves the product for its specified uses, any promotion by the manufacturer for other uses renders the product misbranded.
Executive can be prosecuted for violating the Food, Drug and Cosmetic Act, though this strategy has not been widely used. Executives face the possibility of being hit with fines as much as $100,000 and one year in jail. The FDA can also bar the executives from working in the drug industry, according to the report.
Mr. Blumberg did not offer a timetable for the FDA to take disciplinary actions, according to the report.
Read the Bloomberg news report about FDA prosecutions against pharmaceutical company executives.
Read other coverage about pharmaceutical companies and fraud:
- Wright Medical Resolves Investigations Into Alleged Kickback Scheme, Agrees to Pay $7.9M
- Novartis Pays $422M to Settle Allegations of Illegal Drug Promotion, False Claims, Paying Kickbacks
- Pharmaceutical Company AstraZeneca Settles Allegations of Off-Label Marketing and Paying Kickbacks, Pays $520M