FDA issues guidance on drug safety communication.

FDA issued final guidance that describes its current approach to communicating drug safety information, including emerging safety information, to the public, the agency released in a statement March 2.

The guidance affirms what FDA said was its commitment to communicate important drug safety information in a timely manner, including in some situations when the agency is still evaluating whether to take any regulatory action.

It also includes the factors that influence when such information is communicated. Important drug safety information has the potential to alter the benefit/risk analysis for a drug in a way that can affect decisions about prescribing or taking the drug.

The guidance describes the various methods FDA currently uses to communicate established and emerging drug safety information to the public. In addition to drug product labeling, FDA's methods of communicating important drug safety information includes:

* Public Health Advisories--provide information and advice regarding an emerging drug safety issue or other important public health information to the public, including patients and health care professionals.

* Patient Information Sheets--provide concise summaries in plain language, with the most important information about a particular drug.

* Health care Professional Sheets--provide a summary of important and often emerging drug safety issues, with information about the detection of the issue, and points to consider for clinical decision-making.

* Alerts on Patient Information and Health Professional Sheets--provide a summary of important, and often emerging, drug safety

* issues. Alerts may be placed on public health advisories, or patient and health care professional sheets.

These may include:

* newly observed serious adverse events that may be associated with a drug;

* information about how such serious adverse events might be prevented by appropriate patient selection, monitoring of patients, or use or avoidance of the therapy; and

* information regarding a serious adverse event that FDA believes may be associated with use of a drug in populations in whom the drug was not previously studied.

The guidance describes the role of the Drug Safety Oversight Board and its staff in advising the Director of CDER on the management of and communication about emerging drug safety issues.

In connection with FDA's drug safety initiative, FDA published a draft guidance in May 2005 that described a proposal to establish a new communication channel called the "Drug Watch" Web page to provide information to the public on emerging drug safety issues.

This final guidance (which supersedes the draft guidance on "FDA's 'Drug Watch' for Emerging Drug Safety Information") reflects FDA's consideration of the public's comments, as well as FDA's experience with posting emerging drug safety information. http://www.fda.gov/cder/guidance/index.htm

The guidance on "Drug Safety Information-FDA's Communication to the Public" is available at http://www.fda.gov/cder/guidance/index.htm.