FDA Creates New Drug Safety Board

The US Food and Drug Administration (Rockville, MD, www.fda.gov) will form an independent Drug Safety Oversight Board (DSB). The creation of the new board, announced on Feb. 15 by Health and Human Services (HHS) Secretary Mike Leavitt and Acting FDA Commissioner Lester M. Crawford, follows months of criticism regarding FDA's handling of safety concerns about Cox-2 pain relievers and the pediatric use of antidepressants.

The new safety board will manage important drug safety issues within the Center for Drug Evaluation and Research (CDER). Examples cited include resolving disagreements over approaches to drug safety issues, assessing the need for MedGuides (printed prescription drug information distributed to patients with their prescriptions), and overseeing the development and implementation of CDER-wide drug safety policies.

The DSB will include members from the FDA and medical experts from other HHS agencies and government departments (such as the 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.

The independence of the new board from existing safety oversight divisions within CDER such as the Office of Drug Safety is intended to improve internal decision-making for risk-benefit analyses and consumer safety. Recent criticism of the agency has included accusations by staff employees such as FDA safety officer David J. Graham that the agency has stifled internal dissent.

In an HHS statement released following a meeting with FDA employees, Secretary Leavitt was quoted as saying, "The public has spoken and they want more oversight and openness. 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."

At the same time, FDA also announced the creation of a new "Drug Watch" Web page, to be launched by Feb. 23, for emerging drug data and risk information. At the direction of the new DSB, this page will include emerging information—before regulatory action is taken—about possible serious side effects or other safety risks regarding both previously and newly approved drugs. Through the new Web page, the agency also plans to increase its use of one-page drug information sheets written for healthcare professionals and patients.

The Agency also announced plans to seek public input on how FDA should manage the dissemination of emerging information before regulatory action is taken. The Agency will issue draft guidance covering procedures and criteria for identifying drugs and information for the Drug Watch Web page.

The American Association of Pharmaceutical Scientists (AAPS) was among the first industry groups to voice its support of the new board. A statement by the association quotes AAPS President Jerome Skelly, PhD, as saying, "AAPS applauds the FDA for its proactive decision on this issue," adding that discussing drug risks and benefits in "such as environment" helps ensure public safety.

–Laura Bush