FDA Report Details Steps to Improve Safety Programs

February 1, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Jan. 30)?-In response to a set of recommendations made by the Institute of Medicine, the US Food and Drug Administration issued a report detailing a series of initial steps to improve its safety programs.

Rockville, MD (Jan. 30)-In response to a set of recommendations made by the Institute of Medicine (IOM, Washington, DC, www.iom.edu), the US Food and Drug Administration (FDA, www.fda.gov) issued a report detailing a series of initial steps to improve its safety programs.

FDA asked IOM to assess the US drug-safety system in 2005, and IOM released its report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, in September 2006. The report included recommendations about how FDA could improve its drug-safety efforts.

The recommendations FDA intends to act on include: improving communication and information flow among all stakeholders, strengthening the science that supports FDA’s medical-product safety system, and improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the US drug-safety system.

As part of its effort to improve communication, FDA signed a memorandum of understanding with the US Department of Veterans Affairs (VA, Washington, DC, www.va.gov) to share information and expertise related to the review and use of FDA-regulated drugs, biologics, and medical devices. Together, FDA and VA intend to explore ways to enhance risk communication and the collection of postmarket medical-product safety data. They also will promote the efficient use of tools and expertise for medical-product risk identification.

FDA also intends to develop new scientific approaches to detect, understand, predict, and prevent adverse events. The agency hopes to develop and incorporate new quantitative tools to assess benefit and risk, and it plans to conduct a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis. In addition, FDA plans to engage external management consultants to help the Center for Drug Evaluation and Research (CDER, www.fda.gov/cder) develop a comprehensive strategy for improving CDER’s organizational culture. FDA intends to make organizational and management changes to increase communications among review and safety staff.

If adopted by Congress, many of the recently proposed recommendations for the reauthorization of the Prescription Drug User Fee Act will respond to some of the IOM recommendations, thus providing increased resources for drug safety and added flexibility to FDA in the use of fee funding to address the entire drug life cycle.