Report: FDA to strengthen ongoing evaluation of drugs

According to a news release from the Food and Drug Administration, a new report by the FDA’s Center for Drug Evaluation and Research (CDER) outlines a shift in the agency’s approach to evaluating drug safety, subjecting those approved, “postmarket” drugs to the same level of scrutiny as “premarket” drugs that have not yet received approval.

The FDA also hopes to improve communications with consumers on the subject of drug safety. The news release notes that the CDER released 68 “drug safety communications” in 2011, a substantial increase over the 39 issued in 2012. The aim of such communications is to keep patients and providers informed regarding emergent drug safety concerns.

The impetus for the FDA’s efforts can be traced back to a 2004 policy decision to further address drug safety. In addition, the Food and Drug Administration Amendments Act of 2007 called for dramatic changes in postmarket drug evaluation, including granting the FDA the authority to mandate safety studies for postmarket drugs and issue new requirements for drug labeling in response to new developments.

CDER Director Janet Woodcock, M.D., said that the aim is to improve the “quality, accountability, and timeliness” of the agency’s response to drug safety problems.

The full news release from the FDA can be found here.