US HHS FDA CDER DSOB & WWW (phew!)

The United States Food and Drug Administration annouced that it will be creating a Drug Safety Oversight Board to oversee the management of drug safety issues, and will also create a website to provide emerging information to doctors and patients about the risks and benefits of medicines.

The DSOB will oversee the management of important safety issues, recommending information and updates for placement on the Drug Watch, resolving disagreements over approaches to drug safety issues, assessing the need for MedGuides, and overseeing development and implementation of Center-wide drug safety policies.

Comprised of members from the FDA and medical experts from other Health and Human Services agencies and government departments (e.g., Department of Veterans Affairs), the DSOB will consult with outside medical experts and representatives of patient and consumer groups.

As a complement to the board's oversight, the FDA will create a new Drug Watch section on its website to more quickly and proactively share tailored drug safety information sheets with healthcare professionals and patients. These new and direct communication channels will significantly enhance public knowledge and understanding of safety issues by discussing emerging or potential safety problems even before the FDA has reached conclusions that would prompt a regulatory action. Ultimately, this will include:

• A "Drug Watch Web Page," which will include emerging information for both previously and newly approved drugs about possible serious side effects or other safety risks that have the potential to alter the benefit/risk analysis of a drug, affect patient selection or monitoring decisions, or that can be avoided through measures taken to prevent or mitigate harm.
• "Healthcare Professional Information Sheets," which will be information sheets for healthcare professionals for all drugs on FDA's Drug Watch and all drugs with Medication Guides (FDA-approved patient labeling) containing the most important new information for safe and effective product use, such as known and potential safety issues based on reports of adverse events, new information that may affect prescribing of the drug, and the approved indications and benefits of the drug, and
• "Patient Information Sheets," information sheets for patients containing new safety information as well as basic information about how to use the drug in a consumer friendly format for all products on Drug Watch.

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

Visit the FDA CDER website (opens in new window).

Article References
FDA CDER Drug Safety Fact Sheet and Press Release (opens in new window). Accessed 3/29/2005.