News

Posted On: 12/12/2006

Congress Passes Dietary Supplement and Nonprescription Drug Consumer Protection Act

PharmaManufacturing.com

The U.S. Congress has passed S. 3546, "The Dietary Supplement and Nonprescription Drug Consumer Protection Act," an amendment to the Federal Food, Drug, and Cosmetic Act, which requires that manufacturers submit to the FDA any reports they receive of serious adverse events (AERs). The legislation was introduced to the U.S. Senate this past June by Senators Orrin Hatch (R-Utah), John Cornyn (R-Texas), Tom Harkin (D-Iowa), Richard Durbin (D-Ill.), Michael Enzi (R-Wyo.) and Edward Kennedy (D-Mass.), and in the U.S. House by Representatives Chris Cannon (R-Utah) and Frank Pallone (D-N.J.).

The law mandates that over-the-counter drug and supplement manufacturers report serious adverse events to the FDA within 15 business days of knowledge of the event, and requires that those manufacturers maintain a record of all such reports for six years. It also makes the submission of knowingly false reports a punishable offense.

Adverse event reporting does not associate a cause to the adverse event, but does let the FDA know that an event has occurred. Federal legislation will pre-empt state and local laws, and provide clear, understandable guidelines to consumers, healthcare professionals and manufacturers.

Having passed in both the House and Senate, the bill may proceed to a conference committee of senators and representatives to work out differences in the versions of the bill that each chamber approved. The bill then awaits the signature of the President before becoming law.