FDA releases draft of guidance on drug-safety issues

The FDA’s Center for Drug Evaluation and Research (CDER) released a new draft guidance on how it develops and classifies drug-safety issues.

The guidance, Drug Safety Information – FDA’s Communication to the Public, describes how CDER communicates emerging drug-safety information.

“In recent years, CDER has begun making information on potential drug risks available to the public earlier ­­-- often while the Center is evaluating safety data and determining whether any regulatory action is warranted,” according to a statement from CDER.

The guidance indicated that post-marketing safety issues will be tracked by CDER if they have the potential to lead to:

Withdrawal of FDA approval of a drug; limitations on a use in a specific population or subpopulation.

Additions or modifications to the Warnings and Precautions or Indications sections of the labeling Medication Guide, or other patient package insert.

Other risks.

In addition to the methods FDA already uses to communicate drug safety issues, the agency is exploring: concise advisories and other Internet postings; more detailed short articles; articles in trade and professional journals; and a standardized, 1-document solution for patient medication information.

CDER also further clarified its Drug Safety Communication, a tool used to communicate important safety information about marketed drugs.