FDA Improvements in Drug Safety Monitoring

On February 15, 2005, HHS Secretary Mike Leavitt and Acting FDA Commissioner Lester M. Crawford unveiled a new emboldened vision for FDA that will promote a culture of openness and enhanced oversight within the Agency. As part of this vision, FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues, and will provide emerging information to health providers and patients about the risks and benefits of medicines.

Acting FDA Commissioner Crawford announced specific proposals for immediate and fundamental steps to improve the way the FDA manages drug safety information. These proposals focus on making FDA’s review and decision-making processes more independent and transparent.

FDA will enhance the independence of internal deliberations and decisions regarding risk/ benefit analyses and consumer safety by creating an independent Drug Safety Oversight Board (DSB). The DSB will oversee the management of important drug safety issues within the Center for Drug Evaluation and Research (CDER). The DSB will comprise members from the FDA and medical experts from other HHS agencies and government departments (e.g., Department of Veterans Affairs) who will be appointed by the FDA Commissioner. The board also will consult with other medical experts and representatives of patient and consumer groups.

FDA will also increase the transparency of the Agency’s decision-making process by establishing new and expanding existing communication channels to provide targeted drug safety information to the public. These channels will be used to help ensure that established and emerging drug safety data are quickly available in an easily accessible form. The increased openness will enable patients and their healthcare professionals to make better-informed decisions about individual treatment options. The Agency is proposing a new “Drug Watch” Web page for emerging data and risk information and increased use of consumer-friendly information sheets written especially for healthcare professionals and patients.

As FDA develops these communications formats, the Agency will be soliciting public input on how FDA should manage potential concerns associated with disseminating emerging information prior to regulatory action. The Agency will issue draft guidance on procedures and criteria for identifying drugs and information for the Drug Watch Web page. In addition, FDA will actively seek feedback from healthcare professionals and patients on how best to make this information available to them.

A cornerstone of all information collection, evaluation, and communication proposals in an age of increasing electronic health information must be a strict adherence to maintaining patient privacy. FDA is committed to maintaining patient privacy as it undertakes these steps.

From U.S. FDA

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