Michael O'Donnell - Blog Post #4

Name of Guidance: Guidance – Drug Safety Information – FDA’s Communication to the Public

Status of Guidance: Final

Release Date: March 2007

Link to Guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072281.pdf

Target Audience: Healthcare professionals, patients, and the public

Laws and Regulations Referenced:

• 21 U.S.C. 352
• 21 U.S.C. 355
• 21 CFR 201.66
• 21 CFR 202.1(e)
• 21 CFR 208.1
• 21 CFR 310.305
• 21 CFR 310.501
• 21 CFR 310.515
• 21 CFR 314.80
• 21 CFR 314.80(a)
• 21 CFR 314.98
• 21 CFR 600.80
• Docket No. 2005D-0062

Guidances and miscellaneous documents referenced:

• Guidance for industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
• FDA Fact Sheet (February 15, 2005)

Summary:
The guidance is about the process of presenting drug safety issues as publicly available information, as explained by the FDA to the general public. The guidance explicates in detail when, where, how, why, and what drug safety information is communicated.

The beginning of the guidance specifically discusses the importance of making drug safety data public for the purpose of fostering informed decision-making regarding any drug treatment. This applies not just to the general public, but healthcare professionals as well that are involved in the treatment process. The goal of the FDA in communication of drug safety is to aid all parties involved in or interested in such information to make as informed decisions as possible.

In the sections following the introduction, the guidance details what exactly constitutes safety information valuable to the public. It is explained that serious adverse drug experiences are an example of one type of information that should be made public, and this is broken down into two categories: post-approval in a new setting, and frequently occurring adverse experiences in patient subpopulations. Also recommended for dissemination to the public are medication errors. The guidance points out that these are just examples of what can be communicated, and that there are no limitations on what else might be necessary to make the public aware of, in the name of safety.

The guidance mentions many considerations that the FDA must fully evaluate before making a decision on issuing a public statement about safety concerns for a drug. Some of the bulleted list in the guidance includes factors such as plausibility, degree of exposure in a patient population, risk magnitude, and the severity of adverse experiences. It is explained in the guidance that the timing of when the FDA releases the safety information to the public is normally after a complete analysis of an approved drug, but there are instances where the FDA may feel it necessary to publicly release safety data prior to finalizing a decision on what, if any regulatory action is needed.

On page 6 of the guidance, a table is included that summarizes the communication methodologies for all manner of drug safety information. The table organizes this data with brief descriptions for type of communication, content, and target audience. Each of the distinct types of data is explored in much further detail in pages 7-10 of the guidance.

The next several sections of the guidance are devoted to explication of where safety information can be found by the public, how confidentiality of contributed information is protected, and how the data is continually updated. The closing sections of the guidance focus on FDA and sponsor interaction prior to releasing data to the public, and concern about implications for promotion of prescription drugs.

Rationale:
The goal of the FDA with this guidance is to explain their thinking and organizational approach to the release of drug safety information to the general public. The guidance will address concerns or confusion from healthcare professionals and the public, about the process of making safety data publicly available.

Resulting Recommendations:
Healthcare professionals with concerns about the release of drug safety data, and how it will effect promotion of prescription drugs, should consult this guidance to be aware of the FDA methodology for what, how, when, why, and where this information will be released to the public.

Also, any member of the general public that has questions about what safety data the FDA makes available, or has concerns about dissemination of drug safety information, would benefit from reading this guidance.

Impact:
This guidance is a multi-dimensional dissection of FDA drug safety data communication to the public. It answers questions in concise detail about the FDA decision-making process, the characteristics of the safety data communicated, and the methodology behind the multi-faceted process of how, why, when, where, and what is released to the public. Understanding of the public dissemination of drug safety information is fully realized upon a review of this guidance.