Associate directors for safety and safety-regulatory program managers have begun their postmarket drug safety oversight roles within FDA's Office of New Drugs' 17 drug review divisions.

The positions were created as part of a culture change promised by CDER in its response to the Institute of Medicine's call for greater consideration of postmarket safety issues during new drug reviews (¹ [A#00690070010], p. 17).

Although the move to division safety managers is at an early stage, "the impact has already been positive and will continue to grow," OND Director John Jenkins told "The Pink Sheet." They "are working to more effectively oversee the portfolio of safety issues within each division and to ensure close working relationships with the staff in OSE [Office of Surveillance and Epidemiology]."

The new associate directors for safety are medical officers with experience in drug review and pre- and postmarket safety issues. In many cases, the deputy division directors have assumed this role, which includes coordinating and overseeing all postmarket safety issues within the division, Jenkins said.

Working with medical teams and division directors, the associate directors for safety set priorities, allocate resources for postmarket safety review, and ensure that other parts of the agency are consulted when appropriate.

In light of complaints that OSE concerns are given short shrift during drug review, the associate directors for safety will work with counterparts in OSE to ensure that staff from both offices regularly meet to discuss scientific and regulatory issues and to resolve disagreements. To ensure that pre- and postmarket staff members are clear on their roles, CDER is developing internal procedures that outline how OND and OSE are to interact on postmarket safety issues.

The safety-regulatory program manager is an administrative position that coordinates postmarket safety activities within a division. This includes maintaining a new safety database, following up with sponsors of products being assessed for new postmarket safety issues, and ensuring that project timelines are met.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

Postmarket Safety Managers Begin Oversight Roles In Drug Review Divisions

More from Archive

More from Pink Sheet