FDA reorganizing to improve drug safety, development.(Practice Trends)

Officials at the Food and Drug Administration are planning to reorganize its Center for Drug Evaluation and Research in an effort to improve the agency's approach to drug safety and to help improve drug development.

The FDA plans to appoint a new associate director at the Center for Drug Evaluation and Research (CDER) to focus on broad drug safety, policy, and communication issues. Agency officials also plan to consolidate some drug safety-related activities and have that staff report to the new associate director. This would include MedWatch reporting staff and Drug Safety Oversight Board staff.

The reorganization plans also call for elevating the status of the current Office of Drug Safety, which is primarily responsible for epidemiology and surveillance activities, and its staff will report to the CDER director. The name of the office will also be changed.

"Over the past year, the Center has been the focus of intense internal and external scrutiny regarding drug safety," Dr. Steven K. Galson, CDER director, said in a memo to the center staff. "The current organizational structure perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety."

While the Office of Drug Safety is a small unit, about half of CDER's resources are dedicated to drug safety activities, said Deborah Henderson, R.N., director of the Office of Executive Programs at CDER.

But the proposal includes no plans to make the Office of Drug Safety independent from CDER, as some in Congress have proposed. When reviewing drugs, FDA staff members need to balance the effectiveness of the drug against the risks, Ms. Henderson said, so pulling the safety activities out of the center wouldn't be in the best interests of public health.