Leavitt: Reforms Will Improve Oversight and Openness at FDA

Health and Human Services Secretary Mike Leavitt says drug safety reforms at the Food and Drug Administration will improve openness and oversight and will enhance the agency's 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," Leavitt said during a Feb. 15, 2005, meeting at FDA 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."

As a complement to the board's oversight, the FDA will improve transparency by sharing drug safety information sooner, more broadly, and conveniently. The agency will launch a new Drug Watch Web page and will proactively share tailored drug safety information sheets with health care 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.

The 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 FDA-approved patient labeling (MedGuides), and overseeing development and implementation of drug safety policies. The board will be composed of members from the FDA and medical experts from other HHS agencies and government departments such as Veterans Affairs. The board also will consult with outside medical experts and representatives of patient and consumer groups.

"FDA understands that the public expects better and more prompt information about the medicines they take every day," says Acting FDA Commissioner Dr. Lester M. Crawford. "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

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.
Healthcare Professional Sheets--One-page information sheets for health care professionals for all drugs on the FDA's Drug Watch and all drugs with MedGuides, containing the most important new information for safe and effective product use.
Patient Information Sheets--One-page 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 the Drug Watch.

"The FDA is an icon of trust, a certifier of safety, an enabler of innovation, and a repository of information," 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."

For More Information

www.fda.gov/cder/drugsafety.htm

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