Final Rule for Generic Reporting Withdrawn

February 12, 2009

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration withdrew this week its direct final rule on Reporting Information About Authorized Generic Drugs.

Rockville, MD (Feb. 12)-The US Food and Drug Administration withdrew this week its direct final rule on Reporting Information About Authorized Generic Drugs. Originally issued in September 2008 and scheduled to go into effect this week (Feb. 11, 2009), the rule was set to require drugmakers to report information on authorized generics in their annual new drug application (NDA) reports going back to 1999. The rule was part of the FDA Amendments Act (FDAAA).

As part of the September 2007 FDAAA, the agency must publish on its website a list of all authorized generic drugs included in manufacturers’ annual reports. FDA also must update the list every quarter and notify relevant federal agencies, including the Federal Trade Commission, that the list has been published.

Under FDA’s direct final rules procedures, the receipt of any significant adverse comment will result in the withdrawal of the direct final rule, according to a written statement from the agency’s Associate Commissioner for Policy and Planning. Comments received will be considered in developing a final rule.