New board to improve internal oversight, consumer communication of drug safety issues

The new independent Drug Safety Oversight Board (DSB) within CDER will employ a two-pronged approach to create "a new culture of openness, improved oversight, and enhanced independence," according to FDA officials.

Specifically, the board will: 1) oversee the internal management of drug safety issues and 2) provide better communication channels regarding medication safety. The DSB will include representatives from FDA, HHS agencies, the DVA, and patient and consumer groups.

As part of its oversight component, DSB will address internal FDA disagreements over approaches to drug safety issues and oversee implementation of CDER drug safety policies.

Components of the proposed website include consumer-friendly literature for health-care professionals and patients. A 1-page sheet for health-care professionals will provide the latest notices on safe and effective product use, such as potential adverse events, new prescribing information, and approved indications. Patient hand-outs will include updated safety and drug use information.

FDA acting commissioner nominee Lester M. Crawford, DVM, PhD, said of the newly created DSB: "FDA understands that the public expects better and more prompt information about the medicines they take every day. 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 US consumers." Dr Crawford added: "There has been considerable publicity regarding high-profile products about which safety questions have been raised. It is important that these concerns do not distort the fact that drugs are safer today than they have ever been before."

The announcement about the creation of the new board came just before a joint FDA advisory committee meeting in February on the risk-benefit profiles of specific NSAIDs, especially the COX-2 inhibitors.

SOURCES HHS website. Reforms will help improve oversight and openness at FDA [press release]. Available at: http://www.hhs.gov/news/press/2005pres/20050215.html. Accessed April 25, 2005.

FDA website. FDA improvements in drug safety monitoring [press release]. Available at: http://www.fda.gov/oc/factsheets/drugsafety.html. Accessed April 25, 2005.

FDA website. Speech before FDA all-hands briefing with new HHS secretary Mike Leavitt [press release]. Available at: http://www.fda.gov/oc/speeches/2005/safedrugs0215.html. Accessed April 25, 2005.

Acronyms
CDER=Center for Drug Evaluation and Research; HHS=US Department of Health & Human Services; DVA=Department of Veterans Affairs