Status: Final
Date: March 2007
Target Audience: Healthcare professionals, patients, and the public
Laws and Regulations:
  • 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
  • Guidance for industry on Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
  • FDA Fact Sheet (February 15, 2005)
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 also healthcare professionals 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.
Then 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: (1) post-approval in a new setting, and (2) frequently occurring adverse experiences in patient subpopulations. Also recommended for dissemination to the public are medication errors. These are just examples of what can be communicated, and 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, including factors such as (A) plausibility, (B) degree of exposure in a patient population, (C) risk magnitude, and (D) the severity of adverse experiences. The FDA releases the safety information to the public 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.
A table is included that summarizes the communication methodologies for all manner of drug safety information with brief descriptions for type of communication, content, and target audience.
Then there is 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. Then the focus is on FDA and sponsor interaction prior to releasing data to the public, and concern about implications for promotion of prescription drugs.
The goal of the FDA is to explain their thinking and organizational approach to the release of drug safety information to the general public. It addresses 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 affect 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 with questions about what safety data the FDA makes available, or has concerns about dissemination of drug safety information, would benefit from reading this guidance.
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.
For more information on this issue, contact the Kulkarni Law Firm.