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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Regulatory Information about Biologics Advertising & Promotional Labeling

Food and Drug Administration Amendments Act of 2007 (FDAAA)

(Some of the links on this page take you to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and the Code of Federal Regulations on other government Web sites. Once you leave this page, click the back button on your browser to return to the FDA Web site.) 

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 ยง 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:

 

 

Contact FDA

301-827-3028
301-827-3528 Fax
Advertising and Promotional Labeling Branch (APLB)

Office of Compliance and Biologics Quality

Center for Biologics Evaluation and Research

Food and Drug Administration

1401 Rockville Pike, HFM-602

Rockville, MD 20852-1448