Regulatory Information about Biologics Advertising & Promotional Labeling
Food and Drug Administration Amendments Act of 2007 (FDAAA)
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On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA) which includes the reauthorization and expansion of the Prescription Drug User Fee Act (PDUFA).
The FDA may require the submission of any television advertisement for a drug for review before dissemination of the television advertisement, under Sec. 901 of Title IX of FDAAA, which also contains a number of other provisions related to DTC advertising, including civil monetary penalties for violative DTC ads (amends § 303 of FDCA). Any person who disseminates or causes another party to disseminate a false or misleading DTC ad shall be liable for a civil penalty of up to $250,000 for the first violation, and up to $500,000 for subsequent violations in a 3 year period.
For more details on FDAAA and PDUFA, refer to:
- FDAAA (Public Law 110-85)
- Prescription Drug User Fees
- PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 Through 2012
- Federal Register Document: DTC User Fee Program Will Not be Implemented(1/16/08)