FDA Revs Up Counter-Terrorism Activities

Washington, DC-To improve FDA's ability to respond to terrorist attacks, acting commissioner Bernard Schwetz tapped Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), to establish a formal crisis management program for the agency. Woodcock moved to the commissioner's office in November to develop a program to better track and coordinate FDA responses to terrorism. She will

• coordinate FDA actions with those of other government agencies

• develop contingency plans in case FDA becomes incapacitated

• prepare a long-range counter-terrorism program as part of FDA's permanent crisis management effort.

Woodcock is working with Andrea Meyerhoff, former counter-bioterrorism coordinator in FDA's Office of Science Coordination & Communications. Other key players are Kathryn Zoon, director of the Center for Biologics Evaluation and Research, who oversees anti-bioterrorism efforts for vaccines, the nation's blood supply, and biotech therapies,and Dianne Murphy, head of CDER's new Office of Pediatric Drug Development & Special Initiatives.

Woodcock may also work with former FDA acting commissioner Michael Friedman, who recently joined PhRMA to serve as industry's counter-bioterrorism spokesman. A physician, former cancer researcher, and now senior vice-president at Pharmacia, Friedman will head industry efforts to gain liability protection for biological warfare therapies and to provide the Department of Health and Human Services with information about available medicines and the capacity to make new ones. Friedman's assignment reflects industry efforts to visibly step up anti-bioterrorism responses. In October, corporate CEOs formed a PhRMA task force on emergency preparedness headed by Aventis CEO Richard Markham. The group told HHS Secretary Tommy Thompson that it is ready to provide all the medicines and vaccines the government needs, and Friedman is forming a scientific task force to meet regularly with government experts to evaluate current research and the need for new products and initiatives.

One proposal is to use industry's vast sales force to inform doctors how to treat conditions created by bioterrorism and other public health threats. The PhRMA CEO group suggested such an initiative in a recent meeting with the new Office of Homeland Security Director Tom Ridge. Companies say they will teach reps to deliver information about proper medical care, even if it means touting a competitor's product. Ridge said he'd consider the idea, but because that would open doctors' doors to often maligned sales forces, it has prompted strong opposition from patient advocates and healthcare providers.

Woodcock says she plans to return to CDER in a few months. Meanwhile, her deputy, Steven Galson, will serve as CDER's acting director. Galson has already established a new Office of Pharmacoepidemiology & Statistical Science and is preparing a risk management action plan for pharmaceuticals. In addition, FDA is forming a new pharmaceutical risk management advisory committee to provide expert advice on safety issues.