FDA NEWS RELEASE

FDA Seeks Input on Communication of Drug Safety Information
Public Meeting Brings Together Experts to Assess Risk Communication Tools and Plan for Future Initiatives

As part of the Food and Drug Administration's continued commitment to improve communication about risks posed by prescription medications, its Center for Drug Evaluation and Research (CDER) is holding a public meeting today to evaluate current practices and to explore new tools and strategic partnerships to enhance future efforts.

"In the past year we have made significant strides in alerting healthcare professionals and their patients of emerging risks associated with prescription medications," said Andrew von Eschenbach, MD, Acting FDA Commissioner. "We intend to use the public feedback we receive at this meeting to advance our understanding of the effectiveness of our current efforts and to develop new tools to hone our ability to inform the public."

As patients take an increasingly active role in their healthcare, FDA is working to devise a modern system for communicating drug safety information to educate healthcare providers and their patients that will aid in the evaluation of the benefits and risks of taking prescription medications, ultimately leading to more informed prescribing and treatment decisions. Currently, almost 50 percent of CDER's resources across the organization are dedicated to drug safety.

To date, there are a number of initiatives currently underway to enhance FDA's systems for alerting physicians and their patients about the risks associated with prescription drugs. These activities will be expanded significantly as Congress has supported this progress by providing a $10 million increase for FDA's drug safety activities in the FY 2006 appropriations bill.

• FDA's aggressive development of electronic health information sharing has led to several new tools to disseminate information more rapidly and effectively to consumers and physicians. The development of a new standardized electronic drug label to be made available over the next year will allow physicians to access the most up to date information about a prescription drug through the DailyMed website, developed in collaboration with the National Library of Medicine. In addition, a new drug safety information page provides consumer-friendly drug safety information sheets to be shared proactively with healthcare professionals and patients: http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm.
• To further enhance the identification of risks associated with prescription medications, FDA has signed agreements with a number of external partners to increase drug surveillance capabilities. On October 7, 2005, FDA awarded four contracts that give the agency access to databases containing pharmacoepidemiologic information, which will be used to study the association of various medicines with serious adverse effects. FDA is also collaborating with Duke Clinical Research Institute (DCRI) to establish a consortium with other partners, including NIH, academia, and industry to perform data mining exercises using data from submissions that include more than 180,000 ECGs to identify trends and early indicators of cardiovascular risk in new and existing drugs.
• As a reflection of the continued commitment to a cross-Center approach to drug safety within CDER, a new organizational structure was unveiled in October 2005. After a comprehensive nationwide search, Dr. Gerald J. Dal Pan, M.D., was appointed Director of the Office of Drug Safety to provide a focus for critical safety-related activities such as policy development and implementation.
• FDA has committed to a new vision to promote a culture of openness and enhanced oversight within the agency. As a result, an independent Drug Safety Oversight Board (DSOB) was created to oversee the management of drug safety. The Board recently began deliberating about factors to be considered when deciding whether to notify the public about important drug safety concerns by analyzing recent efforts to communicate risks. The Board continues to conduct timely and comprehensive evaluations of drug safety concerns and assist FDA in ensuring that safe and effective drugs are available for patients: http://www.fda.gov/cder/drug/DrugSafety/DSOBmeetings/default.htm.

In addition to today's meeting, FDA is also seeking additional feedback about risk communication through an Institute of Medicine study on the effectiveness of the U.S. drug safety system. The goal of the research is to help further define additional steps to be taken in the post-marketing phase to monitor drug risks and benefits. The agency also conducts routine consultations on complex drug safety and risk management issues with experts from FDA, other federal agencies, academia, the pharmaceutical industry, and the healthcare community to gain additional perspective.

"It is imperative that FDA lead a collaborative effort to develop a comprehensive and effective approach to risk communication by engaging experts from a variety of disciplines," said Steven Galson, MD, Director of CDER. "Ensuring the safe and effective use of drugs throughout their lifecycle requires us to work closely with medical and patient groups to make sure they have the most up-to-date information about risks and benefits in order to make educated decisions about the products they use."

The public meeting is being held on December 7 and 8, 2005, at the National Transportation Safety Board, Boardroom and Conference, 429 L'Enfant Plaza, Washington, D.C., to address questions related to documents currently distributed by FDA. Six questions will be posed by FDA to gather information about which communication tools are effective and how risk communications can be improved. These tools include Patient Information Sheets, Healthcare Professional Information Sheets, Public Health Advisories, Press Releases, the MedWatch Listserv Safety Updates, Patient Safety News, CDER Educational Campaigns, and the CDER Internet site.

Please see the attached Federal Register Notice of Public Meeting for additional meeting information and background material: http://www.fda.gov/OHRMS/DOCKETS/98fr/05-19759.htm.

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