October 2007 - FDA Reform Bill Signed by President Bush

In late September, President Bush signed into law H.R. 3580, the Food and Drug Administration (FDA) reauthorization and drug safety bill, which gives the FDA the authority to seek monetary penalties for advertising found to be false or misleading. The bill contains an optional provision allowing the FDA Commissioner to require pre-review of DTC advertising for specific new drugs, but this pre-review requirement only applies to television ads. The new law also instructs the FDA to establish standards for determining whether the major statement in television advertisements is presented in a clear and conspicuous manner.

Less than 24 hours before final passage of the House-Senate Conference Report, conferees included a provision in the bill that requires print advertisements to contain a 1-800 number for consumers to use to report to the FDA any adverse drug reactions. While this provision does not apply to broadcast ads, it does direct the FDA to conduct a study on whether this 1-800 number should be included in television advertising as well.

First Published:
October 31, 2007