US FDA OTC NDA Review Process "In Six Months"

Developing a formalized and standardized over-the-counter New Drug Application review process to offer consistency, accountability and transparency will benefit the US Food and Drug Administration, the OTC industry and the public, according to Murray Lumpkin, deputy director for review management at the FDA Center for Drug Evaluation and Review.

He told the US Nonprescription Drug Manufacturers Association's Research and Scientific Development conference this month (see also page 13), that the agency should meet this goal within the next six months. To do so, discussions and final decisions need to be made on areas such as sign-off (the switch decision, the labeling and any interaction between the two) and the role of the advisory committee (does it need to meet to discuss the switch of the fourth product in a category, for example). Project management is being put into place in terms of process (an overview of products in various stages of review), management of individual Investigational new Drugs or reviews, and setting and reviewing time line templates without having them become rigid.

A standard policy is also needed on scheduling company/agency meetings, he said, noting this is not just an OTC problem, and would also include timeframes for responses. Issues relating to nomenclature also need to be resolved, provided that companies realize that early decisions on a name are not a guarantee that a product will either be approved or switched. He also commented that government downsizing will affect the timetable for getting out the last remaining OTC Final Monographs.