New Day at FDA (Food and Drug Administration)

Reforms Will Improve Oversight and Openness at FDA
Secretary Leavitt Meets with Employees and Announces a New Day at FDA

In a meeting today with employees, HHS Secretary Mike Leavitt shared an emboldened vision for the Food and Drug Administration (FDA) that included a new culture of openness, improved oversight and enhanced independence. In keeping with this vision, the FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues, and will provide emerging information to doctors and patients about the risks and benefits of medicines.

"The public has spoken and they want more oversight and openness," Secretary Leavitt said during a meeting with FDA employees at the Parklawn Headquarters in Rockville, Md. "They want to know what we know, what we do with the information and why we do it. We will address their concerns by cultivating openness and enhanced independence."

The independent Drug Safety Oversight Board will oversee the management of important safety issues such as 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. The board will be comprised of members from FDA and medical experts from other HHS agencies and government departments (e.g., Department of Veterans Affairs) and will consult with outside medical experts and representatives of patient and consumer groups.

As a complement to the board's oversight, FDA will improve transparency by sharing drug safety information sooner and more broadly and conveniently. FDA will launch a new Drug Watch Web Page 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 FDA has reached conclusions that would prompt a regulatory action.

Acting FDA Commissioner Dr. Lester M. Crawford accompanied Secretary Leavitt at today's announcement. "FDA understands that the public expects better and more prompt information about the medicines they take everyday," Dr. Crawford said. "Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers."

The new communication channels include:

The Drug Watch Web Page. At the direction of the new Drug Safety Oversight Board, this page 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. The agency will enhance access to this information and call for assistance in prioritizing and further evaluating potential adverse health concerns.

Healthcare Professional Information Sheets. One-page 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.

Patient Information Sheets. One-page 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.

"The FDA is an icon of trust, a certifier of safety, an enabler of innovation and a repository of information," Secretary Leavitt said. "We will keep the promise of the FDA brand by putting in place more rigorous oversight and collecting and sharing important and emerging information about drug safety and effectiveness."

More detailed information about today's announcement can be found on FDA's Web site at fda.gov/cder/drugsafety. ###

FOR IMMEDIATE RELEASE Tuesday, Feb. 15, 2005 FDA Press Office (301) 827-6242